2018 Medicines in Development for Cancer...Vicinium Eleven Biotherapeutics BCG-refractory high-grade...
Transcript of 2018 Medicines in Development for Cancer...Vicinium Eleven Biotherapeutics BCG-refractory high-grade...
2018 Medicines in Development for Cancer
Bladder CancerProduct Name Sponsor Indication Development Phase
ABI-009 AADi Bioscience non-muscle invasive bladder cancer Phase I/II
(nab-rapamycin/mTOR inhibitor) Los Angeles, CA www.aadibio.com
ALT-801 Altor BioScience non-muscle invasive bladder cancer Phase I/II
(tumor antigen-specific T-cell Miramar, FL www.altorbioscience.com
receptor linked to IL-2) NantKwest
Culver City, CA
ALT-803 Altor BioScience non-muscle invasive bladder cancer Phase II
(IL-15 superagonist protein complex) Miramar, FL (BCG naïve) (Fast Track), www.altorbioscience.com
NantKwest non-muscle invasive bladder cancer
Culver City, CA (BCG unresponsive) (Fast Track)
B-701 BioClin Therapeutics 2L locally advanced or metastatic Phase I/II
(anti-FGFR3 mAb) San Ramon, CA bladder cancer www.bioclintherapeutics.com
Bavencio® EMD Serono 1L urothelial cancer Phase III
avelumab Rockland, MA www.emdserono.com
(anti-PD-L1 inhibitor) Pfizer www.pfizer.com
New York, NY
BC-819 BioCanCell Therapeutics non-muscle invasive bladder cancer Phase II
(gene therapy) Cambridge, MA (Fast Track) www.biocancell.com
Medicines in Development: Cancer ǀ 2018 1
Bladder CancerProduct Name Sponsor Indication Development Phase
Capzola® Spectrum Pharmaceuticals non-muscle invasive bladder cancer application submitted
apaziquone Henderson, NV (Fast Track) www.sppirx.com
Cavatak® Viralytics bladder cancer (+pembrolizumab) Phase I
coxsackievirus Sydney, Australia www.viralytics.com
CG0070 Cold Genesys non-muscle invasive bladder cancer Phase II
(oncolytic immunotherapy) Santa Ana, CA www.coldgenesys.com
Cotellic® Genentech urothelial cancer (+atezolizumab) Phase I
cobimetinib South San Francisco, CA www.gene.com
CV-301 Bavarian Nordic bladder cancer (+anti-PD-L1) Phase II
(CEA-MUC-1-TRICOM cancer vaccine) Morrisville, NC www.bavarian-nordic.com
Cyramza® Eli Lilly bladder cancer Phase III
ramucirumab Indianapolis, IN www.lilly.com
enfortumab vedotin (ASG-2ME) Astellas urothelial cancer Phase II
(antibody-drug conjugate) Northbrook, IL www.astellas.com
Seattle Genetics www.seattlegenetics.com
Bothell, WA
Halaven® Eisai bladder cancer Phase I/II
eribulin Woodcliff Lake, NJ www.eisai.com
Medicines in Development: Cancer ǀ 2018 2
Bladder CancerProduct Name Sponsor Indication Development Phase
Imfinzi® MedImmune 1L bladder cancer (+tremelimumab) Phase III
durvalumab Gaithersburg, MD www.medimmune.com
1L unresectable stage IV bladder Phase II
cancer (+olaparib) www.medimmune.com
INCB54828 Incyte bladder cancer Phase II
(FGFR1/2/3 inhibitor) Wilmington, DE www.incyte.com
INO-5401 Inovio Pharmaceuticals bladder cancer Phase II
(T-cell activating DNA immunotherapy) Plymouth Meeting, PA www.inovio.com
MAGE-A10 TCR Adaptimmune bladder cancer Phase I/II
(T-cell receptor therapy) Philadelphia, PA www.adaptimmune.com
MV-NIS Vyriad bladder cancer Phase I
(oncolytic virus cancer vaccine) Rochester, MN www.vyriad.com
nadofaragene firadenovec FKD Therapies superficial bladder cancer Phase III
(IFNA2B gene therapy) Kuopio, Finland
NC-6004 NanoCarrier bladder cancer (+gemcitabine) Phase II
(cisplatin micellar nanoparticle) Chiba, Japan www.nanocarrier.co.jp
NEO-PV-01 Neon Therapeutics bladder cancer Phase I
(personal neo-antigen vaccine) Cambridge, MA www.neontherapeutics.com
Medicines in Development: Cancer ǀ 2018 3
Bladder CancerProduct Name Sponsor Indication Development Phase
Opdivo® + Yervoy® Bristol-Myers Squibb urothelial cancer Phase III
nivolumab + ipilimumab Princeton, NJ www.bms.com
Rubraca® Clovis Oncology advanced or metastatic bladder cancer Phase II
rucaparib Boulder, CO www.clovisoncology.com
(PARP inhibitor)
RX-3117 Rexahn Pharmaceuticals metastatic bladder cancer Phase II
(DNA and RNA synthesis inhibitor) Rockville, MD www.rexahn.com
sacituzumab govitecan Immunomedics metastatic urothelial cancer Phase II
(anti-TROP-2-SN-38 ADC) Morris Plains, NJ www.immunomedics.com
TAR-200 TARIS Biomedical non-muscle invasive bladder cancer, Phase I
(DNA synthesis inhibitor) Lexington, MA muscle invasive bladder cancer www.tarisbiomedical.com
(Fast Track)
Tecentriq® Genentech muscle-invasive bladder cancer, Phase III
atezolizumab South San Francisco, CA 1L metastatic urothelial cancer www.gene.com
(+/- chemotherapy)
non-muscle invasive bladder cancer Phase I
www.gene.com
VesiGel™ UroGen Pharma bladder cancer (Fast Track) Phase II
mitomycin intravesicular New York, NY www.urogen.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 4
Bladder CancerProduct Name Sponsor Indication Development Phase
Vesimune™ UroGen Pharma high-grade non-muscle invasive Phase II
imiquimod intravesicular New York, NY bladder cancer www.urogen.com
ORPHAN DRUG
Vicinium™ Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III
recombinant fusion protein Cambridge, MA invasive bladder cancer www.elevenbio.com
BCG-refractory high-grade non-muscle Phase I
invasive bladder cancer (+durvalumab) www.elevenbio.com
Brain CancerProduct Name Sponsor Indication Development Phase
2X-111 2X Oncology brain metastases from breast cancer, Phase I completed
(liposomal doxorubicin) Cambridge, MA recurrent glioblastoma www.2xoncology.com
ORPHAN DRUG
abexinostat Xynomic Pharmaceuticals brain Phase I
(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com
Ad-RTS-hIL12 ZIOPHARM Oncology glioblastoma Phase II
(DNA-based therapy) Boston, MA www.ziopharm.com
ORPHAN DRUG
glioblastoma (+nivolumab), Phase I
glioblastoma (stereotactic treatment), www.ziopharm.com
pediatric brain tumors
Medicines in Development: Cancer ǀ 2018 5
Brain CancerProduct Name Sponsor Indication Development Phase
AG-881 Agios Pharmaceuticals glioma Phase I
(pan-IDH inhibitor) Cambridge, MA www.celgene.com
Celgene
Summit, NJ
aglatimagene besadenovec Advantagene glioma, pediatric glioma Phase II
(gene therapy) Auburndale, MA www.advantagene.com
ORPHAN DRUG
pediatric brain tumors Phase I
www.advantagene.com
AMG 596 Amgen glioblastoma Phase I
(anti-EGFRvIII x anti-CD3 Thousand Oaks, CA www.amgen.com
bispecific T-cell engager)
ANG1005 AngioChem brain metastases from breast cancer, Phase II
(peptide-paclitaxel conjugate) Montreal, Canada glioblastoma (Fast Track) www.angiochem.com
ORPHAN DRUG
antineoplaston therapy Burzynski Research Institute diffuse intrinsic pontine glioma Phase II
ORPHAN DRUG Houston, TX www.burzynskiresearch.com
APX005M Apexigen recurrent refractory brain tumors Phase I
(CD40 agonistic antibody) San Carlos, CA www.apexigen.com
AU101 Aurora BioPharma recurrent glioblastoma Phase I/II
(HER2-CD28 CAR-T cell therapy) Cambridge, MA www.aurora-biopharma.com
Medicines in Development: Cancer ǀ 2018 6
Brain CancerProduct Name Sponsor Indication Development Phase
AU105 Aurora BioPharma newly-diagnosed glioblastoma Phase I/II
(HER2-CMV CAR-T cell therapy) Cambridge, MA www.aurora-biopharma.com
Avastin® Genentech brain metastases Phase II
bevacizumab South San Francisco, CA www.gene.com
AZD1390 AstraZeneca glioblastoma (+radiation) Phase I
(ATM kinase inhibitor) Wilmington, DE www.astrazeneca.com
Azixa® Cytovia glioblastoma Phase II
verubulin Englewood Cliffs, NJ www.immunepharma.com
ORPHAN DRUG
BAL101553 Basilea Pharmaceutica newly-diagnosed glioblastoma Phase I
(tumor checkpoint inhibitor) Basel, Switzerland www.basilea.com
Adult Brain Tumor Consortium
Baltimore, MD
bavituximab Oncologie newly-diagnosed glioblastoma Phase II
Boston, MA www.oncologie.international
BMX-001 BioMimetix glioma Phase I/II
(mangano porphyrin antioxidant Greenwood Village, CO www.biomimetix.com
mimetic)
BXQ-350 Bexion Pharmaceuticals glioblastoma Phase I
(apoptosis stimulant) Covington, KY www.bexionpharma.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 7
Brain CancerProduct Name Sponsor Indication Development Phase
capmatinib (INC280) Novartis Oncology glioblastoma (combination therapy) Phase I completed
(c-Met inhibitor) East Hanover, NJ www.novartis.com
Incyte
Wilmington, DE
CC-122 (avadomide) Celgene glioblastoma Phase I
(pleiotropic pathway modulator) Summit, NJ www.celgene.com
Cerebral EDV™ EnGeneIC glioblastoma Phase I
doxorubicin encapsulated nanocells New York, NY www.engeneic.com
ORPHAN DRUG
DCC-2618 Deciphera Pharmaceuticals glioblastoma, glioma Phase I
(PDGFR-alpha kinase switch Waltham, MA www.deciphera.com
control inhibitor)
ORPHAN DRUG
DCVax®-L Northwest Biotherapeutics glioblastoma Phase III
cancer vaccine Bethesda, MD www.nwbio.com
ORPHAN DRUG
depatuxizumab mafodotin AbbVie glioblastoma Phase III
(anti-EGFR antibody-drug conjugate) North Chicago, IL www.abbvie.com
ORPHAN DRUG
pediatric brain tumors Phase I
www.abbvie.com
Medicines in Development: Cancer ǀ 2018 8
Brain CancerProduct Name Sponsor Indication Development Phase
Dicopp™ Cantex Pharmaceuticals recurrent glioblastoma Phase II
copper gluconate/disulfiram Weston, FL www.cantex.com
ORPHAN DRUG
DM-CHOC-PEN Dekk-Tec primary brain cancer, Phase II
New Orleans, LA brain metastases www.dekk-tec.com
DSP-7888 Sumitomo Dainippon Pharma recurrent glioblastoma Phase II
(adegramotide/nelatimotide) Osaka, Japan (combination therapy) www.ds-pharma.com
ORPHAN DRUG
eflornithine oral Orbus Therapeutics anaplastic astrocytoma Phase III
(ornithine decarboxylase inhibitor) Palo Alto, CA www.orbustherapeutics.com
ORPHAN DRUG
epacadostat Incyte glioblastoma Phase I
(IDO1 inhibitor) Wilmington, DE www.incyte.com
ERC1671 Epitopoietic Research glioblastoma Phase II
(therapeutic cancer vaccine) Pasadena, CA www.erc-immunotherapy.com
ORPHAN DRUG
fimepinostat (CUDC-907) Curis brain tumor Phase I
(HDAC/PI3K inhibitor) Lexington, MA www.curis.com
Medicines in Development: Cancer ǀ 2018 9
Brain CancerProduct Name Sponsor Indication Development Phase
GBM-Lamp-Vax Immunomic Therapeutics glioblastoma Phase II
(dendritic cell vaccine comprising Rockville, MD www.immunomix.com
CMV antigen pp65 expressed as Duke University
fusion protein with LAMP) Durham, NC
University of Florida
Gainesville, FL
GDC-0084 Kazia Therapeutics glioblastoma Phase I
(PI3K inhibitor) Sydney, Australia www.kaziatherapeutics.com
ORPHAN DRUG
Gilotrif® Boehringer Ingelheim Pharmaceuticals glioma Phase II
afatinib Ridgefield, CT www.boehringer-ingelheim.com
HER2.taNK NantKwest recurrent HER2-positive glioblastoma Phase I
(CAR-T cell therapy) Culver City, CA www.nantkwest.com
ICT-121 ImmunoCellular Therapeutics glioblastoma Phase I
(dendritic cell vaccine) Westlake Village, CA www.imuc.com
ifabotuzumab Humanigen glioblastoma Phase I
(anti-EphA3 mAb) Brisbane, CA www.humanigen.com
Olivia Newton-John Cancer
Research Institute
Heidelberg, Australia
indoximod NewLink Genetics pediatric malignant brain tumors Phase I
(IDO inhibitor) Ames, IA (+temozolomide) www.newlinkgenetics.com
Medicines in Development: Cancer ǀ 2018 10
Brain CancerProduct Name Sponsor Indication Development Phase
INO-5401 Inovio Pharmaceuticals glioblastoma Phase II
(T-cell activating DNA immunotherapy) Plymouth Meeting, PA www.inovio.com
ivosidenib Agios Pharmaceuticals glioma Phase I
(IDH1 inhibitor) Cambridge, MA www.agios.com
marizomib Celgene glioblastoma Phase II
(proteasome inhibitor) Summit, NJ www.celgene.com
ORPHAN DRUG
MB-101 Mustang Bio glioblastoma Phase I
(CAR-T cell therapy) New York, NY www.mustangbio.com
MDNA55 Medicenna Therapeutics glioblastoma (Fast Track) Phase II
(interleukin-4 superkine) Toronto, Canada www.medicenna.com
ORPHAN DRUG
MNX-100 MetronomX medulloblastoma Phase II
(nifurtimox) Houston, TX www.metronomx.com
MTX110 Midatech Pharma US diffuse interstitial pontine glioma Phase I
(nano-inclusion product) Raleigh, NC www.midatechpharma.com
MV-NIS Vyriad medulloblastoma Phase I
(oncolytic virus cancer vaccine) Rochester, MN www.vyriad.com
Medicines in Development: Cancer ǀ 2018 11
Brain CancerProduct Name Sponsor Indication Development Phase
napabucasin Boston Biomedical recurrent or progressed glioblastoma Phase I/II
(STAT3 inhibitor) Cambridge, MA (+temozolomide) www.bostonbiomedical.com
NEO100 NEONC Technologies recurrent malignant glioma Phase I/II
(perillyl alcohol intranasal) Los Angeles, CA www.neonctech.com
ORPHAN DRUG
NVX-108 NuvOx Pharma glioblastoma (combination therapy) Phase II
(perflenapent nanoparticles) Tucson, AZ www.nuvoxpharma.com
ORPHAN DRUG
Odomzo® Novartis Oncology medulloblastoma Phase II completed
sonidegib East Hanover, NJ www.novartis.com
OKN007 Oblato (GtreeBNT) glioblastoma Phase I
(disufenton sodium) Oklahoma City, OK www.gtreebnt.com
ORPHAN DRUG
omburtamab I-124 Y-mAbs Therapeutics diffuse intrinsic pontine glioma Phase I/II
(B7-H3 inhibitor) New York, NY www.ymabs.com
Medicines in Development: Cancer ǀ 2018 12
Brain CancerProduct Name Sponsor Indication Development Phase
ONC201 Oncoceutics recurrent H3-mutation high-grade Phase II
(dopamine receptor D2/3 antagonist) Philadelphia, PA glioma, recurrent glioblastoma www.oncoceutics.com
ORPHAN DRUG
newly-diagnosed diffuse intrinsic Phase I
pontine glioma (pediatric), www.oncoceutics.com
recurrent H3-mutation
high-grade glioma (pediatric)
Onzeald™ Nektar Therapeutics brain metastases from breast cancer Phase III
etirinotecan pegol San Francisco, CA (Fast Track) www.nektar.com
Opdivo® Bristol-Myers Squibb glioblastoma Phase III
nivolumab Princeton, NJ www.bms.com
OT-101 Autotelic glioblastoma Phase II/III
(TGF-beta antisense) Costa Mesa, CA www.oncotelic.com
ORPHAN DRUG Oncotelic
Agoura Hills, CA
PAC-1 (VO-100) Vanquish Oncology anaplastic astrocytoma, Phase I
(procaspase activating compound-1) Campaign, IL glioblastoma www.vanquishoncology.com
pamiparib (BGB-290) BeiGene USA glioblastoma (combination therapy) Phase I/II
(PARP inhibitor) Cambridge, MA www.beigene.com
PDT with Photofrin® Pinnacle Biologics brain cancer Phase II
porfimer sodium Chicago, IL www.pinnaclebiologics.com
Medicines in Development: Cancer ǀ 2018 13
Brain CancerProduct Name Sponsor Indication Development Phase
PEPIDH1M Annias Immunotherapeutics glioblastoma Phase I/II
(dendritic cell vaccine) Chapel Hill, NC www.aniasimmuno.com
Poly-ICLC Oncovir glioblastoma Phase I/II completed
(biological response modifier) Washington, DC www.oncovir.com
ORPHAN DRUG
Pomalyst® Celgene recurrent or progressive primary Phase II
pomalidomide Summit, NJ brain tumors (ages 1 to < 21 years) www.celgene.com
pritumumab Nascent Biotech glioma Phase II
(human IgG antibody) Vero Beach, FL www.nascentbiotech.com
ORPHAN DRUG
Prophage™ Agenus newly-diagnosed glioblastoma Phase II
vitespen Lexington, MA www.agenusbio.com
ORPHAN DRUG
PT2385 Peloton Therapeutics recurrent glioblastoma Phase II
(HIF-1 alpha inhibitor) Dallas, TX www.pelotontherapeutics.com
relatlimab Bristol-Myers Squibb glioblastoma Phase I
(anti-LAG3 mAb) Princeton, NJ www.bms.com
RRx-001 EpicentRx anaplastic glioma, newly-diagnosed Phase I
(free radical stimulant) La Jolla, CA glioblastoma (combination therapy) www.epicentrx.com
Medicines in Development: Cancer ǀ 2018 14
Brain CancerProduct Name Sponsor Indication Development Phase
selinexor Karyopharm Therapeutics glioblastoma Phase II
(nuclear export inhibitor) Newton, MA www.karyopharm.com
SGT-53 SynerGene Therapeutics recurrent glioblastoma Phase II
(gene therapy) Rockville, MD (+temozolomide)
SL-701 Stemline Therapeutics adult glioblastoma Phase I/II
(brain cancer vaccine) New York, NY www.stemline.com
ORPHAN DRUG
SurVaxM MimiVax glioblastoma Phase II
BIRC5 protein inhibitor vaccine Buffalo, NY www.mimivax.com
Sym004 Symphogen glioblastoma Phase II
(EGFR antagonist mAb) Somerville, NJ www.symphogen.com
Tafinlar® + Mekinist® Novartis Oncology BRAF V600+ relapsed/refractory Phase II
dabrafenib + trametinib East Hanover, NJ high-grade glioma www.novartis.com
tasadenoturev (DNA-2401) DNAtrix recurrent glioblastoma (Fast Track) Phase II
(oncolytic virus immunotherapy) Houston, TX (monotherapy and combination) www.dnatrix.com
ORPHAN DRUG
newly-diagnosed diffuse intrinsic Phase I
pontine glioma www.dnatrix.com
Medicines in Development: Cancer ǀ 2018 15
Brain CancerProduct Name Sponsor Indication Development Phase
TB-403 BioInvent International medulloblastoma Phase I/II
(anti-PIGF mAb) Lund, Sweden www.bioinvent.com
Oncurious
Leuven, Belgium
tesevatinib Kadmon Pharmaceuticals brain metastases, Phase II
(protein tyrosine kinase inhibitor) New York, NY leptomeningeal metastases, www.kadmon.com
recurrent glioblastoma
TG02 Tragara Pharmaceuticals anaplastic astrocytoma, Phase I/II
(CDK inhibitor) Carlsbad, CA glioblastoma www.tragarapharma.com
Toca 511 + Toca Fc Tocagen recurrent high-grade glioma Phase III
(vocimagene amiretrorepvec- San Diego, CA (Fast Track) www.tocagen.com
flucytosine gene therapy)
ORPHAN DRUG
TPI-287 Cortice Biosciences recurrent glioblastoma (+bevacizumab) Phase II
(next generation taxane) New York, NY www.corticebiosciences.com
secondary brain metastases (+radiation) Phase I
www.corticebiosciences.com
trans sodium crocetinate (TSC) Diffusion Pharmaceuticals glioblastoma Phase II
ORPHAN DRUG Charlottesville, VA www.diffusionpharma.com
brain metastases Phase I
www.diffusionpharma.com
Medicines in Development: Cancer ǀ 2018 16
Brain CancerProduct Name Sponsor Indication Development Phase
TRC-102 TRACON Pharmaceuticals glioblastoma Phase II
(methoxyamine hydrochloride) San Diego, CA www.traconpharma.com
TRC-105 TRACON Pharmaceuticals glioblastoma (combination therapy) Phase II
(carotuximab) San Diego, CA www.traconpharma.com
TVB-2640 3-V Biosciences astrocytoma Phase II
(FASN inhibitor) Menlo Park, CA www.3vbio.com
TVI-Brain-1 cancer vaccine TVAX Biomedical astrocytoma, glioblastoma, glioma Phase II completed
ORPHAN DRUG Olathe, KS www.tvaxmedical.com
USL311 Upsher-Smith relapsed/recurrent glioblastoma Phase I/II
(CXCR4 antagonist) Maple Grove, MN www.upsher-smith.com
ORPHAN DRUG
VAL-083 DelMar Pharmaceuticals refractory glioblastoma (Fast Track) Phase III
(dianhydrogalactitol) Menlo Park, CA www.delmarpharma.com
ORPHAN DRUG
varlilumab Celldex Therapeutics glioblastoma Phase II
(anti-CD28 mAb) Hampton, NJ www.celldex.com
VB-111 VBL Therapeutics glioblastoma (Fast Track) Phase III
(ofranergene obadenovec) Modi'in, Israel www.vblrx.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 17
Brain CancerProduct Name Sponsor Indication Development Phase
VBI-1901 VBI Vaccines glioblastoma Phase I/II
(bivalent cancer vaccine) Cambridge, MA www.vbivaccines.com
WP1066 Moleculin Biotech glioblastoma, melanoma Phase I/II
(STAT3 transcription factor inhibitor) Houston, TX metastases to the brain www.moleculin.com
Breast CancerProduct Name Sponsor Indication Development Phase
2X-121 2X Oncology breast cancer Phase II
(PARP/tankyrase inhibitor) Cambridge, MA www.2xoncology.com
abexinostat Xynomic Pharmaceuticals breast cancer (combination therapy) Phase II
(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com
adagloxad simolenin OBI Pharma metastatic breast cancer Phase II
(cancer immunotherapy vaccine) Taipei, Taiwan www.obipharma.com
AE37 (HER2.neu) Antigen Express newly-diagnosed breast cancer Phase II
(Li-key hybrid cancer vaccine) Wellesley, MA www.antigenexpress.com
AE37/GP2 peptide vaccine Antigen Express breast cancer Phase II
(Li-key hybrid cancer vaccine) Wellesley, MA www.antigenexpress.com
afimoxifene (4-OHT) BHR Pharma ductal carcinoma in situ of the breast Phase II
(percutaneous gel formulation) Herndon, VA www.bhr-pharma.com
Medicines in Development: Cancer ǀ 2018 18
Breast CancerProduct Name Sponsor Indication Development Phase
alpelisib Novartis Oncology hormone receptor-positive Phase III
(PI3K-alpha inhibitor) East Hanover, NJ HER2-negative advanced breast cancer www.novartis.com
(postmenopausal women),
2L breast cancer (+ fulvestrant)
metastatic or locally-advanced Phase I
breast cancer (premenopausal) www.novartis.com
Apristor™ Context Therapeutics progesterone receptor-positive Phase II
onapristone Philadelphia, PA metastatic breast cancer www.contexttherapeutics.com
ARX788 Ambrx HER2-positive breast cancer Phase I
(HER2 antibody-drug conjugate) La Jolla, CA www.ambrx.com
AZD5363 (capivasertib) AstraZeneca breast cancer Phase II
(Akt inhibitor) Wilmington, DE www.astrazeneca.com
AZD9496 AstraZeneca estrogen receptor-positive Phase I
(estrogen receptor antagonist) Wilmington, DE breast cancer www.astrazeneca.com
balixafortide (POL6326) Polyphor metastatic breast cancer Phase I
(CXCR4 antagonist) Allschwil, Switzerland (combination therapy) (Fast Track) www.polyphor.com
Bavencio® EMD Serono triple negative breast cancer (+4-1BB) Phase II
avelumab Rockland, MA www.emdserono.com
(anti-PD-L1 inhibitor) Pfizer www.pfizer.com
New York, NY
Medicines in Development: Cancer ǀ 2018 19
Breast CancerProduct Name Sponsor Indication Development Phase
bemcentinib (BGB324) BerGenBio triple negative breast cancer Phase II
(AXL kinase inhibitor) Bergen, Norway (+pembrolizumab) www.bergenbio.com
Bria-IMT™ BriaCell Therapeutics metastatic breast cancer, Phase I/II
SV-BR-1 GM cancer vaccine Berkeley, CA breast cancer (combination therapy) www.briacell.com
CB-839 Calithera Biosciences triple negative breast cancer Phase II
(glutaminase inhibitor) South San Francisco, CA (+paclitaxel) www.calithera.com
Cotellic® Genentech triple negative breast cancer Phase II
cobimetinib South San Francisco, CA (+atezolizumab +/- taxane) www.gene.com
DEBIO 1347 Debiopharm breast cancer Phase I/II
(FGFR 1/2/3 inhibitor) Lausanne, Switzerland www.debiopharm.com
DHES0815A Genentech breast cancer Phase I
South San Francisco, CA www.gene.com
eFT508 eFFECTOR Therapeutics triple negative breast cancer Phase II
(MKNK1/MKNK2 protein inhibitor) San Diego, CA www.effector.com
endoxifen Jina Pharmaceuticals breast cancer Phase II
(estrogen receptor antagonist) Libertyville, IL www.jinapharma.com
endoxifen (topical) Atossa Genetics breast cancer prevention in women Phase II
Seattle, WA with mammographic breast density www.atossagenetics.com
Medicines in Development: Cancer ǀ 2018 20
Breast CancerProduct Name Sponsor Indication Development Phase
ENMD-2076 CASI Pharmaceuticals triple negative breast cancer Phase II
(mulitple kinase inhibitor) Rockville, MD www.casipharmaceuticals.com
enobosarm GTx breast cancer Phase II completed
(SARM) Memphis, TN www.gtxinc.com
entinostat Syndax Pharmaceuticals advanced hormone receptor-positive Phase III
(HDAC inhibitor) Waltham, MA HER2-breast cancer (+exemestane) www.syndax.com
triple negative breast cancer Phase II
(+atezolizumab) www.syndax.com
EP-101 EpiThany breast cancer Phase I
(multi-antigen vaccine) Seattle, WA www.epithany.com
EP-301 EpiThany breast cancer Phase I
(HER2 ICD vaccine) Seattle, WA www.epithany.com
EP-302 EpiThany breast cancer Phase I
(multi-antigen vaccine) Seattle, WA www.epithany.com
ETBX-021 Etubics HER2-expressing breast cancer Phase I
(HER2/neu targeted cancer vaccine) Seattle, WA www.etubics.com
NantBioScience www.nantworks.com
Culver City, CA
Medicines in Development: Cancer ǀ 2018 21
Breast CancerProduct Name Sponsor Indication Development Phase
fulvestrant for injectable Eagle Pharmaceuticals hormone receptor-positive Phase I
suspension Woodcliff Lake, NJ breast cancer www.eagleus.com
fulvestrant intraductal Atossa Genetics breast cancer (neoadjuvant) Phase II
microcatheter delivery Seattle, WA www.atossagenetics.com
G1T38 G1 Therapeutics estrogen receptor-positive Phase II
(CDK4/6 inhibitor) Research Tringle Park, NC HER2-negative breast cancer www.g1therapeutics.com
GDC-0077 (RG6114) Genentech hormone receptor-positive Phase I
(PI3K inhibitor) South San Francisco, CA breast cancer www.gene.com
GDC-9545 (RG6171) Genentech estrogen receptor-positive Phase I
(SERD) South San Francisco, CA HER2-negative metastatic www.gene.com
breast cancer
Gilotrif® Boehringer Ingelheim Pharmaceuticals breast cancer Phase III
afatinib Ridgefield, CT www.boehringer-ingelheim.com
H3B-6545 Eisai estrogen receptor-positive HER2- Phase I
(estrogen receptor alpha antagonist) Woodcliff Lake, NJ negative metastatic breast cancer www.h3biomedicine.com
H3 Biomedicine
Cambridge, MA
Halaven® Eisai breast cancer (+pembrolizumab), Phase I/II
eribulin Woodcliff Lake, NJ breast cancer (+PEGPH20) www.eisai.com
Medicines in Development: Cancer ǀ 2018 22
Breast CancerProduct Name Sponsor Indication Development Phase
Ibrance® Pfizer high risk early breast cancer, Phase III
palbociclib New York, NY HER2-positive breast cancer (adjuvant), www.pfizer.com
early breast cancer (adjuvant)
Imlygic® Amgen triple-negative breast cancer Phase I
talimogene laherparepvec Thousand Oaks, CA (+atezolizumab) www.amgen.com
(oncolytic virus therapy)
Imprime PGG® Biothera Pharmaceuticals triple-negative breast cancer Phase II
immunostimulant PGG glucan Eagan, MN (+pembrolizumab) www.biothera.com
IMT-1012 Immunotope breast cancer Phase I completed
(immunotherapeutic vaccine) Doylestown, PA www.immunotope.com
ipatasertib Array BioPharma 1L triple negative hormone receptor- Phase III
(pan-Akt inhibitor) Boulder, CO positive breast cancer (+chemotherapy) www.arraybiopharma.com
Genentech www.gene.com
South San Francisco, CA
triple negative breast cancer Phase II
(neoadjuvant) www.arraybiopharma.com
www.gene.com
triple negative breast cancer Phase I
(+atezolizumab +taxane) www.arraybiopharma.com
www.gene.com
IPI-549 Infinity Pharmaceuticals triple negative breast cancer Phase I
(PI3K-gamma inhibitor) Cambridge, MA (+nivolumab) www.infi.com
Medicines in Development: Cancer ǀ 2018 23
Breast CancerProduct Name Sponsor Indication Development Phase
IRX4204 Io Therapeutics breast cancer Phase I
(RXR agonist) Santa Ana, CA www.io-therapeutics.com
Kadcyla® Genentech 1L HER2-positive metastatic Phase III
trastuzumab emtansine South San Francisco, CA breast cancer, 3L HER2-positive www.gene.com
metastatic breast cancer
Kanjinti™ Allergan HER2-postive breast cancer application submitted
trastuzumab biosimilar Madison, NJ www.allergan.com
(ABP 980) Amgen www.amgen.com
Thousand Oaks, CA
Keytruda® Merck breast cancer Phase III
pembrolizumab Kenilworth, NJ www.merck.com
Kisqali® Novartis Oncology hormone-receptor positive HER2- Phase III
ribociclib East Hanover, NJ negative breast cancer (adjuvant), www.novartis.com
(CDK4/6 inhibitor) 1L hormone-receptor positive
HER2-negative advanced breast cancer
(premenopausal women),
1L/2L hormone-receptor positive
HER2-negative advanced breast cancer
(postmenopausal women)
Korlym® Corcept Therapeutics triple negative breast cancer (+eribulin) Phase I
mifepristone Menlo Park, CA www.corcept.com
Medicines in Development: Cancer ǀ 2018 24
Breast CancerProduct Name Sponsor Indication Development Phase
ladiratuzumab vedotin Seattle Genetics HER2-negative breast cancer, Phase II
(LIV-1 antibody-drug conjugate) Bothell, WA triple negative breast cancer www.seattlegenetics.com
(+pembrolizumab), triple negative
breast cancer (+atezolizumab)
breast cancer Phase I
www.seattlegenetics.com
lasofoxifene Sermonix Pharmaceuticals estrogen receptor-positive Phase II
(SERM) Columbus, OH metastatic breast cancer www.sermonixpharma.com
LCL161 Novartis Oncology breast cancer (+PDR001) Phase I
(apoptosis protein inhibitor) East Hanover, NJ www.novartis.com
LSZ102 Novartis Oncology estrogen receptor-positive metastatic Phase I
(SERM) East Hanover, NJ breast cancer (monotherapy and www.novartis.com
combination therapy)
Lynparza® AstraZeneca gBRCA-mutated adjuvant breast cancer, Phase III
olaparib Wilmington, DE gBRCA-mutated metastatic breast cancer www.astrazeneca.com
margetuximab MacroGenics HER2-positive breast cancer (Fast Track) Phase III
(anti-HER2 mAb) Rockville, MD www.macrogenics.com
MCLA-128 Merus breast cancer Phase II
(ERBB2/3 receptor antagonist) Utrecht, Netherlands www.merus.nl
Medicines in Development: Cancer ǀ 2018 25
Breast CancerProduct Name Sponsor Indication Development Phase
MCS110 Novartis Oncology triple negative breast cancer Phase II
(CSF-1 mAb) East Hanover, NJ www.novartis.com
ME-344 MEI Pharma HER2-negative breast cancer Phase I/II
(MTORC1/2 protein inhibitor) San Diego, CA (+bevacizumab) www.meipharma.com
MM-121 (seribantumab) Merrimack Pharmaceuticals metastatic breast cancer Phase II
(anti-HER3 mAb) Cambridge, MA www.merrimack.com
MSI-1436 DepYmed HER2-postive breast cancer Phase I
(trodusquemine) Farmingdale, NY www.depymedinc.com
Nerlynx® Puma Biotechnology 3L metastatic HER2-positive breast Phase III
neratinib Los Angeles, CA cancer www.pumabiotechnology.com
(pan-ErbB inhibitor)
HER2-positive breast cancer with brain Phase II
metastases, HER2-positive breast www.pumabiotechnology.com
cancer (neoadjuvant therapy),
metastatic HER2-positive breast cancer,
metastatic ER2-mutant breast cancer
Neuvax™ Sellas Life Sciences HER2-positive breast cancer Phase II
nelipepimut-S New York, NY (Fast Track) www.sellaslifesciences.com
Onivyde® Ipsen Biopharmaceuticals breast cancer Phase I
irinotecan liposome injection Basking Ridge, NJ www.ipsen.com
Medicines in Development: Cancer ǀ 2018 26
Breast CancerProduct Name Sponsor Indication Development Phase
Onzeald™ Nektar Therapeutics metastatic breast cancer (Fast Track) Phase III
etirinotecan pegol San Francisco, CA www.nektar.com
Opdivo® Bristol-Myers Squibb triple negative breast cancer Phase I/II
nivolumab Princeton, NJ www.bms.com
Oraxol Athenex breast cancer Phase III
paclitaxel oral Buffalo, NY www.athenex.com
OTS-167 OncoTherapy Science advanced breast cancer, Phase I
(MELK inhibitor) Kanagawa, China triple-negative breast cancer www.oncotherapy.co.jp
PCA062 Novartis Oncology pCAD-positive triple negative Phase I
(p-cadherin modulator) East Hanover, NJ breast cancer www.novartis.com
pertuzumab subcutaneous + Genentech early breast cancer Phase II
trastuzumab fixed-dose combination South San Francisco, CA www.gene.com
PF-06873600 Pfizer metastatic breast cancer Phase I
(CDK inhibitor) New York, NY www.pfizer.com
poziotinib Spectrum Pharmaceuticals HER2-positive breast cancer Phase II
(pan-HER/tyrosine kinase inhibitor) Henderson, NV www.sppirx.com
Medicines in Development: Cancer ǀ 2018 27
Breast CancerProduct Name Sponsor Indication Development Phase
PTX-200 Prescient Therapeutics HER2-negative breast cancer Phase II
(Akt inhibitor) South Melbourne, Australia www.ptxtherapeutics.com
stage IIB-IV breast cancer Phase I/II
www.ptxtherapeutics.com
PU-H71 Samus Therapeutics metastatic breast cancer Phase I
(HSP90 inhibitor) Topsfield, MA www.samustherapeutics.com
PVX-410 OncoPep metastatic triple negative breast Phase I
(multi-peptide cancer vaccine) Boston, MA cancer (+pembrolizumab), www.oncopep.com
metastatic triple negative breast
cancer (+ durvalumab)
RAD140 Radius Health metastatic breast cancer Phase I
(SARM) Waltham, MA www.radiuspharm.com
rebastinib Deciphera Pharmaceuticals breast cancer (+chemotherapy) Phase I
(TIE2 immunokinase inhibitor) Waltham, MA www.deciphera.com
REM-001 (rostaporfin) Adgero Biopharmaceuticals cutaneous metastatic breast cancer Phase II
(photosensitizer) Princeton, NJ www.adgerobiopharm.com
RG6264 Roche/Genentech HER2-positive breast cancer Phase I
(pertuzumab/trastuzumab Basel, Switzerland www.roche.com
fixed-dose combination)
Medicines in Development: Cancer ǀ 2018 28
Breast CancerProduct Name Sponsor Indication Development Phase
RX-5902 (supinoxin) Rexahn Pharmaceuticals triple negative breast cancer Phase II
(P-p68 inhibitor) Rockville, MD www.rexahn.com
sacituzumab govitecan Immunomedics metastatic triple-negative breast Phase III
(anti-TROP-2-SN-38 ADC) Morris Plains, NJ cancer (Fast Track) www.immunomedics.com
(Breakthrough Therapy)
sapacitabine Cyclacel Pharmaceuticals breast cancer (+seliciclib) Phase II
(nucleoside analogue) Berkeley Heights, NJ www.cyclacel.com
sapanisertib Takeda Oncology breast cancer Phase II
(MTOR protein inhibitor) Deerfield, IL www.takeda.com
SAR439859 Sanofi metastatic breast cancer (+palbociclib) Phase I
(SERD) Bridgewater, NJ www.sanofi.com
SAR566658 Sanofi triple negative breast cancer Phase II
(anti-CA6 antibody-drug conjugate) Bridgewater, NJ www.sanofi.com
SC-005 AbbVie triple negative breast cancer Phase I
(antibody-drug conjugate) North Chicago, IL www.abbvie.com
seviteronel (INO-464) Innocrin Pharmaceuticals triple-negative breast cancer Phase II
(CYP17 lyase inhibitor) Durham, NC (Fast Track), estrogen receptor- www.innocrinpharma.com
positive breast cancer,
male breast cancer
Medicines in Development: Cancer ǀ 2018 29
Breast CancerProduct Name Sponsor Indication Development Phase
talazoparib Pfizer germline BRCA-mutated Phase III
(PARP inhibitor) New York, NY metastatic breast cancer www.pfizer.com
taselisib Genentech estrogen receptor-positive Phase III
(PI3K inhibitor) South San Francisco, CA HER2-negative breast cancer www.gene.com
HER2-negative metastatic breast Phase II
cancer (neoadjuvant) www.gene.com
tavokinogene telsaplasmid Oncosec Medical triple negative breast cancer Phase II
(interleukin-12 gene therapy) San Diego, CA www.oncosec.com
Tecentriq® Genentech 1L triple negative breast cancer Phase III
atezolizumab South San Francisco, CA (+paclitaxel), 1L triple negative breast www.gene.com
cancer (+nab-paclitaxel), triple negative
breast cancer (+nab-paclitaxel)
HER2-positive breast cancer (+K/HP) Phase I
www.gene.com
tesetaxel Odonate Therapeutics HER2-negative hormone receptor- Phase III
(taxane derivative) San Diego, CA positive metastatic breast cancer www.odonate.com
ThermoDox® Celsion recurrent chest wall breast cancer Phase I/II
doxorubicin liposomal Lawrenceville, NJ www.celsion.com
Medicines in Development: Cancer ǀ 2018 30
Breast CancerProduct Name Sponsor Indication Development Phase
TPIV100/110 TapImmune HER2/neu-positive breast cancer Phase I
(T-cell cancer vaccine) Jacksonville, FL www.tapimmune.com
TPIV200 TapImmune triple negative breast cancer Phase II
(folate receptor-alpha vaccine) Jacksonville, FL www.tapimmune.com
trastuzumab biosimilar Celltrion HER2-positive breast cancer application submitted
Incheon, South Korea www.celltrion.com
trastuzumab biosimilar Pfizer metastatic breast cancer application submitted
(PF-05280014) New York, NY www.pfizer.com
trastuzumab biosimilar Samsung Bioepis HER2-postive breast cancer application submitted
(SB3) Incheon, South Korea www.samsungbioepis.com
trastuzumab deruxtecan (DS-8201) Daiichi Sankyo breast cancer (Fast Track) Phase II
(anti-HER2 antibody-drug conjugate) Basking Ridge, NJ www.dsi.com
trastuzumab duocarmazine Synthon Pharmaceuticals pre-treated HER2-positive metastatic Phase III
(anti-HER2 antibody-drug conjugate) Durham, NC breast cancer (Fast Track) www.synthon.com
TRC-105 TRACON Pharmaceuticals breast cancer Phase I
(carotuximab) San Diego, CA www.traconpharma.com
trilaciclib G1 Therapeutics triple negative breast cancer Phase II
(CDK4/CDK6 inhibitor) Research Triangle Park, NC www.g1therapeutics.com
Medicines in Development: Cancer ǀ 2018 31
Breast CancerProduct Name Sponsor Indication Development Phase
TTC-352 TTC Oncology metastatic breast cancer Phase I
(estrogen receptor alpha agonist) Edina, MN
tucatinib Seattle Genetics HER2-postive breast cancer Phase II
(HER2 inhibitor) Bothell, WA (combination therapy) (Fast Track) www.seattlegenetics.com
ORPHAN DRUG
veliparib AbbVie breast cancer Phase III
(PARP inhibitor) North Chicago, IL www.abbvie.com
ORPHAN DRUG
Verzenio® Eli Lilly breast cancer (adjuvant) Phase III
abemaciclib Indianapolis, IN www.lilly.com
hormone receptor-positive/HER2- Phase II
positive metastatic breast cancer www.lilly.com
XMT-1522 Mersana Therapeutics HER2-expressing breast cancer Phase I
(anti-HER2 antibody-drug conjugate) Cambridge, MA www.mersana.com
Zejula® TESARO triple negative breast cancer Phase II
niraparib Waltham, MA (+pembrolizumab) www.tesarobio.com
ZW25 Zymeworks HER2-expressing breast cancer Phase I
(bispecific antibody) Vancouver, Canada www.zymeworks.com
Medicines in Development: Cancer ǀ 2018 32
Colorectal CancerProduct Name Sponsor Indication Development Phase
AbGn-107 AbGenomics colorectal cancer Phase I
(antibody-drug conjugate) Los Altos, CA www.abgenomics.com
ADXS-NEO Advaxis metastatic colon cancer Phase I
(neoepitope-based Princeton, NJ www.advaxis.com
immunotherapy vaccine) Amgen
Thousand Oaks, CA
AlloStim® Immunovative Therapies metastatic colorectal cancer Phase II
cancer vaccine Jerusalem, Israel (+cryoablation) www.immunovative.com
bevacizumab biosimilar Boehringer Ingelheim Pharmaceuticals colorectal cancer Phase III
(BI 695502) Ridgefield, CT www.boehringer-ingelheim.com
bevacizumab biosimilar Tanvex BioPharma metastatic colorectal cancer Phase I
(TX16) San Diego, CA www.tanvex.com
binimetinib Array BioPharma BRAF-mutant colorectal cancer Phase III
(MEK inhibitor) Boulder, CO www.arraybiopharma.com
microsatellite-stable metastatic Phase I/II
colorectal cancer with RAS mutation www.arraybiopharma.com
(+nivolumab +/-ipilimumab)
Medicines in Development: Cancer ǀ 2018 33
Colorectal CancerProduct Name Sponsor Indication Development Phase
colorectal cancer vaccine Targeted Diagnostics and Therapeutics colorectal cancer Phase I
Exton, PA www.viralgeneinc.com
Viral Gene
Exton, PA
CPI-613 Rafael Pharmaceuticals relapsed/refractory metastatic Phase I
(altered energy metabolism- Newark, NJ colorectal cancer www.rafaelpharma.com
derived medicine)
CPP-1X/sul Cancer Prevention Pharmaceuticals colon cancer risk reduction Phase III
(eflornithine + sulindac) Tucson, AZ www.canprevent.com
eFT508 eFFECTOR Therapeutics microsatellite stable colorectal cancer Phase II
(MKNK1/MKNK2 protein inhibitor) San Diego, CA (+avelumab) www.effector.com
eltanexor oral (KPT-8602) Karyopharm Therapeutics colorectal cancer Phase I/II
(nuclear export inhibitor) Newton, MA www.karyopharm.com
encorafenib Array BioPharma colorectal cancer Phase III
(BRAF inhibitor) Boulder, CO www.arraybiopharma.com
ensituximab Precision Biologics advanced colorectal cancer Phase II
(neoplasm antigen inhibitor) Rockville, MD www.precision-biologics.com
entinostat Syndax Pharmaceuticals colorectal cancer (+pembrolizumab) Phase II
(HDAC inhibitor) Waltham, MA www.syndax.com
Medicines in Development: Cancer ǀ 2018 34
Colorectal CancerProduct Name Sponsor Indication Development Phase
entolimod Cleveland BioLabs colorectal cancer (neoadjuvant) Phase I
(TLR5 agonist) Buffalo, N Y www.cbiolabs.com
epacadostat Incyte colorectal cancer Phase I
(IDO1 inhibitor) Wilmington, DE www.incyte.com
ETBX-011 Etubics colorectal cancer Phase I/II completed
(CEA targeted cancer vaccine) Seattle, WA www.etubics.com
NantKWest www.nantkwest.com
Culver City, CA
Hu5F9-G4 Forty Seven advanced colorectal cancer Phase I/II
(CD47 antigen inhibitor mAb) Menlo Park, CA (+cetixumab) www.fortyseveninc.com
Imlygic® Amgen colorectal cancer with liver metastases Phase I
talimogene laherparepvec Thousand Oaks, CA (+atezolizumab) www.amgen.com
(oncolytic virus therapy)
Imprime PGG® Biothera Pharmaceuticals colorectal cancer Phase I/II
immunostimulant PGG glucan Eagan, MN (+atezolizumab +bevacizumab) www.biothera.com
ipatasertib Array BioPharma 1L colorectal cancer (+abiratorone) Phase III
(pan-Akt inhibitor) Boulder, CO www.arraybiopharma.com
Genentech www.gene.com
South San Francisco, CA
Medicines in Development: Cancer ǀ 2018 35
Colorectal CancerProduct Name Sponsor Indication Development Phase
Keytruda® Merck colorectal cancer Phase III
pembrolizumab Kenilworth, NJ www.merck.com
MABp1 XBiotech advanced colorectal cancer (Fast Track), Phase III
Austin, TX symptomatic colorectal cancer www.xbiotech.com
MGD007 MacroGenics colorectal cancer Phase I
(gpA33 x CD3 bispecific antibody) Rockville, MD www.macrogenics.com
napabucasin Boston Biomedical colorectal cancer (+FOLFIRI ) Phase III
(STAT3 inhibitor) Cambridge, MA www.bostonbiomedical.com
ORPHAN DRUG
colorectal cancer Phase II
(combination therapy) www.bostonbiomedical.com
navicixizumab OncoMed Pharmaceuticals metastatic colorectal cancer Phase I
(anti-DLL4/VEGF bispecific mAb) Redwood City, CA www.oncomed.com
ONCOS-102 Targovax colorectal cancer Phase I/II
(oncolytic virus therapy) Oslo, Norway www.targovax.com
OncoVax® Vaccinogen colorectal cancer (Fast Track) Phase III
autologous cancer vaccine Baltimore, MD www.vaccinogeninc.com
Opdivo® + Yervoy® Bristol-Myers Squibb colorectal cancer Phase II
nivolumab + ipilimumab Princeton, NJ www.bms.com
Medicines in Development: Cancer ǀ 2018 36
Colorectal CancerProduct Name Sponsor Indication Development Phase
pLADD Aduro BioTech microsatellite stable colorectal cancer Phase I
(personalised LADD immunotherapy) Berkeley, CA www.aduro.com
PM184 PharmaMar advanced colorectal cancer Phase II
(tubulin polymerisation inhibitor) Madrid, Spain www.pharmamar.com
polyclonal antibody stimulator Cancer Advances colorectal cancer Phase II
(fusion peptide) Durham, NC www.canceradvancesinc.com
PolyPEPI1018 Treos Bio colorectal cancer Phase I
(immunotherapy cancer vaccine) London, United Kingdom www.treosbio.com
SC-006 AbbVie colorectal cancer Phase I
(antibody-drug conjugate) North Chicago, IL www.abbvie.com
Sym004 Symphogen 3L/4L metastatic colorectal cancer Phase III
(EGFR antagonist mAb) Somerville, NJ www.symphogen.com
Tecentriq® Genentech 2L/3L colorectal cancer Phase I
atezolizumab South San Francisco, CA (+bevacizumab +cobimetinib) www.gene.com
trastuzumab deruxtecan (DS-8201) Daiichi Sankyo colorectal cancer Phase II
(anti-HER2 antibody-drug conjugate) Basking Ridge, NJ www.dsi.com
TVB-2640 3-V Biosciences colon cancer Phase II
(FASN inhibitor) Menlo Park, CA www.3vbio.com
Medicines in Development: Cancer ǀ 2018 37
Colorectal CancerProduct Name Sponsor Indication Development Phase
varlilumab Celldex Therapeutics colorectal cancer (+nivolumab) Phase II
(anti-CD28 mAb) Hampton, NJ www.celldex.com
Gastric CancerProduct Name Sponsor Indication Development Phase
AbGn-107 AbGenomics gastric cancer Phase I
(antibody-drug conjugate) Los Altos, CA www.abgenomics.com
andecaliximab Gilead Sciences gastric cancer Phase III
(MMP9 inhibitor mAb) Foster City, CA www.gilead.com
APR-246 Aprea Therapeutics esophageal cancer Phase I
(tumor suppressor protein Boston, MA www.aprea.com
p53 stimulant)
avapritinib Blueprint Medicines unresectable, treatment-resistant Phase I
(PDGFRa/KIT inhibitor) Cambridge, MA gastrointestinal stromal tumors (GIST) www.blueprintmedicines.com
ORPHAN DRUG (Fast Track) (Breakthrough Therapy)
Bavencio® EMD Serono 1L gastric cancer Phase III
avelumab Rockland, MA www.emdserono.com
(anti-PD-L1 inhibitor) Pfizer www.pfizer.com
New York, NY
Medicines in Development: Cancer ǀ 2018 38
Gastric CancerProduct Name Sponsor Indication Development Phase
bemarituzumab Five Prime Therapeutics gastric/gastroesophageal junction Phase I
(FGFR2b receptor antagonist) South San Francisco, CA cancer www.fiveprime.com
ORPHAN DRUG
BMS-986205 Bristol-Myers Squibb advanced gastric cancer Phase II
(IDO1 inhibitor) Princeton, NJ (+nivolumab +ipilimumab +relatlimab) www.bms.com
cellspan esophageal implant Biostage esophageal cancer in clinical trials
ORPHAN DRUG Holliston, MA www.biostage.com
CPP-1X Cancer Prevention Pharmaceuticals gastric cancer Phase II
(eflornithine + high dose powder sachet) Tucson, AZ www.canprevent.cpom
ORPHAN DRUG
crenolanib AROG Pharmaceuticals GIST (Fast Track) Phase III
(tyrosine kinase inhibitor) Dallas, TX www.arogpharmaceuticals.com
DCC-2618 Deciphera Pharmaceuticals GIST Phase III
(PDGFR-alpha kinase switch Waltham, MA www.deciphera.com
control inhibitor)
ORPHAN DRUG
DKN-01 Leap Therapeutics esophagogastric cancer (+/-paclitaxel), Phase I/II
(anti-DKK1 mAb) Cambridge, MA esophagogastric cancer www.leaptx.com
(+pembrolizumab), gastric cancer
(+/-paclitaxel)
Medicines in Development: Cancer ǀ 2018 39
Gastric CancerProduct Name Sponsor Indication Development Phase
IMAB362 (zolbetuximab) Astellas gastric cancer, gastroesophageal Phase III
(anti-claudin 18.2 mAb) Northbrook, IL junction adenocarcinoma www.astellas.com
ORPHAN DRUG
Imfinzi® MedImmune gastric cancer (+tremelimumab), Phase II
durvalumab Gaithersburg, MD esophageal cancer (+tremelimumab) www.medimmune.com
1L esophageal cancer Phase I
(+tremelimumab +chemotherapy) www.medimmune.com
Kanjinti™ Allergan HER2-positive gastric cancer application submitted
trastuzumab biosimilar Madison, NJ www.allergan.com
(ABP 980) Amgen www.amgen.com
Thousand Oaks, CA
Keytruda® Merck esophageal cancer Phase III
pembrolizumab Kenilworth, NJ www.merck.com
Lonsurf® Taiho Oncology gastric cancer Phase III
tipiracil/trifluridine Princeton, NJ www.taihooncology.com
Lynparza® AstraZeneca gastric cancer (+AZD6738) Phase II
olaparib Wilmington, DE www.astrazeneca.com
margetuximab MacroGenics gastric cancer (+anti-PD-1) Phase II
(anti-HER2 mAb) Rockville, MD www.macrogenics.com
Medicines in Development: Cancer ǀ 2018 40
Gastric CancerProduct Name Sponsor Indication Development Phase
masitinib AB Science 1L GIST Phase III
(protein tyrosine kinase inhibitor) Paris, France www.ab-science.com
ORPHAN DRUG
napabucasin Boston Biomedical gastrointestinal cancer Phase I/II
(STAT3 inhibitor) Cambridge, MA (+chemotherapy) www.bostonbiomedical.com
ORPHAN DRUG
Opdivo® Bristol-Myers Squibb esophageal cancer, gastric cancer, Phase III
nivolumab Princeton, NJ gastroesophageal junction www.bms.com
adenocarcinoma
Opdivo® + Yervoy® Bristol-Myers Squibb gastric cancer, esophageal cancer Phase III
nivolumab + ipilimumab Princeton, NJ www.bms.com
Oraxol Athenex gastric cancer (+ramucirumab) Phase I
paclitaxel oral Buffalo, NY www.athenex.com
PCA062 Novartis Oncology pCAD-positive esophageal cancer Phase I
(p-cadherin modulator) East Hanover, NJ www.novartis.com
pegargiminase Polaris Pharmaceuticals gastrointestinal cancer (+FOLFOX) Phase I/II
(ADI-PEG-20) San Diego, CA www.polarispharma.com
PEGPH20 Halozyme Therapeutics gastric cancer (+pembrolizumab), Phase I
(pegylated recombinant San Diego, CA gastric cancer (+atezolizumab) www.halozyme.com
human hyalurinodase)
Medicines in Development: Cancer ǀ 2018 41
Gastric CancerProduct Name Sponsor Indication Development Phase
PLX9486 Plexxikon GIST Phase I
(c-kit inhibitor) Berkeley, CA www.plexxikon.com
polyclonal antibody stimulator Cancer Advances gastric cancer Phase III
(fusion peptide) Durham, NC www.canceradvancesinc.com
ORPHAN DRUG
rivoceranib LSK Biopharma advanced or metastatic gastric cancer Phase III
(VEGFr-2 antagonist) Salt Lake City, UT www.lskbiopharma.com
ORPHAN DRUG
ropidoxuridine Shuttle Pharmaceuticals gastrointestinal cancer Phase I
(radiation sensitizer) Rockville, MD www.shuttlepharma.com
Sutent® Pfizer GIST (pediatric) Phase II completed
sunitinib New York, NY www.pfizer.com
Tecentriq® Genentech gastric cancer Phase I
atezolizumab South San Francisco, CA (+bevacizumab +chemotherapy) www.gene.com
tislelizumab (BGB-A317) BeiGene USA esophageal squamous cell carcinoma Phase III
(anti-PD-1 mAb) Cambridge, MA www.beigene.com
Celgene www.celgene.com
Summit, NJ
trastuzumab biosimilar Celltrion HER2-positive gastric cancer application submitted
Incheon, South Korea www.celltrion.com
Medicines in Development: Cancer ǀ 2018 42
Gastric CancerProduct Name Sponsor Indication Development Phase
XmAb18087 Xencor GIST Phase I
(SSTR2 x CD3 bispecific mAb) Monrovia, CA www.xencor.com
XMT-1522 Mersana Therapeutics HER2-expressing gastric cancer Phase I
(anti-HER2 antibody-drug conjugate) Cambridge, MA www.mersana.com
ZW25 Zymeworks HER2-expressing gastric cancer Phase I
(bispecific antibody) Vancouver, Canada www.zymeworks.com
ORPHAN DRUG
Head and Neck CancerProduct Name Sponsor Indication Development Phase
ADXS-NEO Advaxis metastatic head and neck cancer Phase I
(neoepitope-based Princeton, NJ www.advaxis.com
immunotherapy vaccine) Amgen
Thousand Oaks, CA
axalimogene filolisbac (AXAL) Advaxis metastatic head and neck cancer Phase II
(cancer immunotherapy vaccine) Princeton, NJ (+durvalumab) www.advaxis.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 43
Head and Neck CancerProduct Name Sponsor Indication Development Phase
Bavencio® EMD Serono locally advanced head and neck cancer, Phase III
avelumab Rockland, MA locally-advanced squamous cell www.emdserono.com
(anti-PD-L1 inhibitor) Pfizer carcinoma of the head and neck www.pfizer.com
New York, NY
squamous cell carcinoma of the Phase II
head and neck (+OX40 or 4-1BBB) www.emdserono.com
www.pfizer.com
biropepimut-S (GL-0817) Gliknik squamous cell carcinoma of the Phase II
(MAGEA 3 immunomodulator) Baltimore, MD oral cavity www.gliknik.com
ORPHAN DRUG
BMX-001 BioMimetix head and neck cancer Phase I
(mangano porphyrin antioxidant Greenwood Village, CO www.biomimetix.com
mimetic)
CDX-3379 Celldex Therapeutics squamous cell carcinoma of the Phase II
(anti-ErbB3 mAb) Hampton, NJ head and neck www.celldex.com
Cotellic® Genentech head and neck cancer (+atezolizumab) Phase I
cobimetinib South San Francisco, CA www.gene.com
COTI-2 Cotinga Pharmaceuticals head and neck cancer Phase I
(p53 gene modulator) London, Canada www.cotingapharma.com
DPX-E7 Immunovaccine HPV-related head and neck cancer Phase I/II
(peptide cancer vaccine) Halifax, Canada www.imvaccine.com
Medicines in Development: Cancer ǀ 2018 44
Head and Neck CancerProduct Name Sponsor Indication Development Phase
epacadostat Incyte head and neck cancer Phase I
(IDO1 inhibitor) Wilmington, DE www.incyte.com
evofosfamide Molecular Templates squamous cell carcinoma of the Phase I
Austin, TX head and neck (+ipilimumab) www.mtem.com
ficlatuzumab AVEO Oncology squamous cell carcinoma of the Phase II
(HGF/c-Met inhibitor) Cambridge, MA head and neck www.aveooncology.com
Gilotrif® Boehringer Ingelheim Pharmaceuticals squamous cell carcinoma of the Phase III completed
afatinib Ridgefield, CT head and neck www.boehringer-ingelheim.com
IMA201 Immatics US squamous cell carcinoma of the Phase I
(adoptive T-cell therapy) Houston, TX head and neck www.immatics.com
Medicines in Development: Cancer ǀ 2018 45
Head and Neck CancerProduct Name Sponsor Indication Development Phase
Imfinzi® MedImmune 1L squamous cell carcinoma of the Phase III
durvalumab Gaithersburg, MD head and neck (+tremelimumab), www.medimmune.com
2L squamous cell carcinoma of the
head and neck (+tremelimumab)
squamous cell carcinoma of the Phase II
head and neck (+AZD5069), www.medimmune.com
squamous cell carcinoma of the
head and neck (+AZD9150),
squamous cell carcinoma of the
head and neck (+MEDI0457)
locally-advanced squamous cell Phase I
carcinoma of the head and neck (+ RT) www.medimmune.com
Imlygic® Amgen squamous cell carcinoma of the Phase I
talimogene laherparepvec Thousand Oaks, CA head and neck (+permbrolizumab) www.amgen.com
(oncolytic virus therapy)
Imprime PGG® Biothera Pharmaceuticals head and neck cancer Phase II
immunostimulant PGG glucan Eagan, MN (+pembrolizumab) www.biothera.com
IPI-549 Infinity Pharmaceuticals head and neck cancer (+nivolumab) Phase I
(PI3K-gamma inhibitor) Cambridge, MA www.infi.com
IRX-2 IRX Therapeutics squamous cell carcinoma of the Phase II
(citoplurikin) New York, NY head and neck (Fast Track) www.irxtherapeutics.com
Medicines in Development: Cancer ǀ 2018 46
Head and Neck CancerProduct Name Sponsor Indication Development Phase
LN-145 Iovance Biotherapeutics squamous cell carcinoma of the Phase II
(tumor-infiltrating lymphocyte) San Carlos, CA head and neck www.iovance.com
MAGE-A10 TCR Adaptimmune head and neck cancer Phase I/II
(T-cell receptor therapy) Philadelphia, PA www.adaptimmune.com
monalizumab Innate Pharma head and neck cancer (+cetuximab), Phase II
(NKG2A checkpoint receptor Marseille, France head and neck cancer (+cetuximab) www.innate-pharma.com
antagonist)
Multikine® CEL-SCI head and neck cancer Phase III
leukocyte interleukin Vienna, VA www.cel-sci.com
ORPHAN DRUG
NC-6004 NanoCarrier head and neck cancer Phase I
(cisplatin micellar nanoparticle) Chiba, Japan (combination therapy) www.nanocarrier.com
Opdivo® + Yervoy® Bristol-Myers Squibb head and neck cancer Phase III
nivolumab + ipilimumab Princeton, NJ www.bms.com
PCA062 Novartis Oncology pCAD-positive head and neck cancer Phase I
(p-cadherin modulator) East Hanover, NJ www.novartis.com
prexasertib Eli Lilly head and neck cancer Phase I
(CHK1 inhibitor) Indianapolis, IN www.lilly.com
Medicines in Development: Cancer ǀ 2018 47
Head and Neck CancerProduct Name Sponsor Indication Development Phase
Proxinium™ Eleven Biotherapeutics squamous cell carcinoma of the Phase I
recombinant fusion protein Cambridge, MA head and neck (Fast Track) www.elevenbio.com
ORPHAN DRUG
RM-1929 Aspyrian Therapeutics head and neck cancer (Fast Track) Phase II
(EGFR antagonist) San Diego, CA www.aspyriantherapeutics.com
SD-101 Dynavax Technologies squamous cell carcinoma of the Phase I/II
(TLR9 agonist) Berkeley, CA head and neck (+pembrolizumab) www.dynavax.com
SF1126 SignalRx Pharmaceuticals head and neck cancer Phase II
(PI3K/mTOR inhibitor) San Diego, CA www.signalrx.com
Tecentriq® Genentech squamous cell carcinoma of the Phase III
atezolizumab South San Francisco, CA head and neck (+/- chemotherapy) www.gene.com
tipifarnib Kura Oncology HRAS-mutant head and neck cancer Phase II
(farnesyltranstransferase inhibitor) San Diego, CA www.kuraoncology.com
TT10 (EBVST) Tessa Therapeutics nasopharyngeal cancer (Fast Track) Phase III
(EBV antigen-specific CTL) Singapore www.tessatherapeutics.com
ORPHAN DRUG
TT12 (armoured HPVST) Tessa Therapeutics oropharyngeal cancer Phase I
(HPV-specific T-cell therapy) Singapore www.tessatherapeutics.com
Medicines in Development: Cancer ǀ 2018 48
Head and Neck CancerProduct Name Sponsor Indication Development Phase
varlilumab Celldex Therapeutics head and neck cancer (+nivolumab) Phase II
(anti-CD28 mAb) Hampton, NJ www.celldex.com
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
ABBV-621 AbbVie hematologic malignancies Phase I
(TRAIL receptor agonist) North Chicago, IL www.abbvie.com
AEB1102 Aeglea Biotherapeutics myelodysplastic syndromes Phase I
(pegzilarginase) Austin, TX www.aegleabio.com
ALRN-6924 Aileron Therapeutics hematologic malignancies Phase II
(MDM2/MDMX antagonist) Cambridge, MA www.aileronrx.com
myelodysplastic syndromes Phase I
www.aileronrx.com
anagrelide controlled-release Sellas Life Sciences essential thrombocythemia Phase II
New York, NY www.sellaslifesciences.com
APG-1387 Ascentage Pharma hematologic malignancies Phase I
(IAP protein inhibitor) Rockville, MD en.ascentagepharma.com
Medicines in Development: Cancer ǀ 2018 49
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
APR-246 Aprea Therapeutics myelodysplastic syndromes Phase I
(tumor suppressor protein Boston, MA www.aprea.com
p53 stimulant)
ARQ 531 ArQule hematologic malignancies Phase I
(BTK inhibitor) Burlington, MA www.arqule.com
ASTX727 Astex Pharmaceuticals myelodysplastic syndromes Phase III
(DNMT inhibitor) Pleasanton, CA www.astx.com
ATA520 Atara Biotherapeutics hematologic malignancies Phase I
(WT1-specific T-cell therapy) South San Francisco, CA www.atarabio.com
AZD4573 AstraZeneca hematologic malignancies Phase I
(CDK9 inhibitor) Wilmington, DE www.astrazeneca.com
AZD5991 AstraZeneca hematologic malignancies Phase I
(MCL-1 protein inhibitor) Wilmington, DE www.astrazeneca.com
Bavencio® EMD Serono hematologic malignancies Phase I
avelumab Rockland, MA www.emdserono.com
(anti-PD-L1 inhibitor) Pfizer www.pfizer.com
New York, NY
BAY1251152 Bayer Pharmaceuticals hematologic malignancies Phase I
(PTEFb inhibitor) Whippany, NJ www.pharma.bayer.com
Medicines in Development: Cancer ǀ 2018 50
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
Beleodaq® Spectrum Pharmaceuticals UGT1A1 wild type gene hematologic Phase I
belinostat Henderson, NV malignancies, UGT1A1*28 genotype www.sppirx.com
hematologic malignancies
bemcentinib (BGB324) BerGenBio myelodysplastic syndromes Phase I/II
(AXL kinase inhibitor) Bergen, Norway www.bergenbio.com
BI 836858 Boehringer Ingelheim Pharmaceuticals myelodysplastic syndromes Phase II
(anti-CD33 mAb) Ridgefield, CT www.boehringer-ingelheim.com
ORPHAN DRUG
BL-8040 BioLineRx hypoplastic myelodysplastic syndromes Phase II
(CXCR4 chemokine receptor antagonist) Modi’in, Israel (combination therapy) www.biolinerx.com
BPX-701 Bellicum Pharmaceuticals myelodysplastic syndromes Phase I
(T-cell receptor therapy) Houston, TX www.belicum.com
BSK01™ Kiromic relapsed/refractory hematologic Phase I/II
(tumor-associated peptide antigen Houston, TX malignancies www.kiromic.com
pulsed dendritic cell vaccine)
BXCL702 BioXcel Therapeutics hematologic malignancies Phase I
(enzyme inhibitor) Branford, CT www.bioxceltherapeutics.com
Medicines in Development: Cancer ǀ 2018 51
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
Calquence® Acerta Pharma B-cell malignancies Phase III
acalabrutinib South San Francisco, CA www.astrazeneca.com
AstraZeneca
Wilmington, DE
hematologic malignancies (+AZD6738), Phase I
hematologic malignancies (+vistusertib) www.astrazeneca.com
CBLC137 Incuron hematologic malignancies Phase I
(curaxin) Buffalo, NY www.incuron.com
CC-486 Celgene lower-risk myelodysplastic syndromes Phase III
(oral azacitidine) Summit, NJ www.celgene.com
myelodysplastic syndromes Phase II
(post-hypomethylating agent failure) www.celgene.com
CC-90002 Celgene myelodysplastic syndromes Phase I
(anti-CD47 antibody) Summit, NJ www.celgene.com
cerdulatinib Portola Pharmaceuticals relapsed/refractory B-cell malignancies Phase II
(Syk/JAK inhibitor) South San Francisco, CA www.portola.com
CLR-131 Cellectar Biosciences hematologic malignancies Phase II
(phospholipid-drug conjugate) Madison, WI www.cellectar.com
Medicines in Development: Cancer ǀ 2018 52
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
CNDO-109 Fortress Biotech myelodysplastic syndromes Phase I
(natural killer cell stimulant) New York, NY www.fortressbiotech.com
CPI-0610 Constellation Pharmaceuticals acute myelodysplastic syndromes, Phase I/II
(BET protein inhibitor) Cambridge, MA myelofibrosis, myelodysplastic/ www.constellationpharma.com
myeloproliferative neoplasms
CPI-613 Rafael Pharmaceuticals relapsed/refractory myelodysplastic Phase II
(altered energy metabolism- Newark, NJ syndromes www.rafaelpharma.com
derived medicine)
Cresemba® Astellas hematologic malignancies (pediatric) Phase I
isavuconazonium Northbrook, IL www.astellas.com
Basilea Pharmaceutica
Basel, Switzerland
CX-01 Cantex Pharmaceuticals myelodysplastic syndromes Phase II
(dociparstat sodium) Weston, FL www.cantex.com
CYAD-01 Celyad hematologic malignancies Phase I
(NKG2D CAR-T cell therapy) New York, NY www.celyad.com
DCC-3014 Deciphera Pharmaceuticals hematologic malignancies Phase I
(CSF1R inhibitor) Waltham, MA www.deciphera.com
Medicines in Development: Cancer ǀ 2018 53
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
DS-3032 Daiichi Sankyo hematologic malignancies Phase I
(MDM2 inhibitor) Basking Ridge, NJ www.dsi.com
DSP-7888 Sumitomo Dainippon Pharma hematologic malignancies Phase I
(adegramotide/nelatimotide) Osaka, Japan www.ds-pharma.com
eltanexor oral (KPT-8602) Karyopharm Therapeutics high-risk myelodysplastic syndromes Phase I/II
(nuclear export inhibitor) Newton, MA www.karyopharm.com
entospletinib Gilead Sciences hematologic malignancies Phase II
(Syk inhibitor) Foster City, CA www.gilead.com
epacadostat Incyte B-cell malignancies Phase I
(IDO1 inhibitor) Wilmington, DE www.incyte.com
ET190 Eureka Therapeutics hematologic malignancies Phase I
(anti-CD19 CAR-T cell therapy) Emeryville, CA www.eurekatherapeutics.com
fedratinib Celgene myelofibrosis Phase III
(JAK2 inhibitor) Summit, NJ www.celgene.com
Impact Biomedicines
San Diego, CA
FF-10501-01 FUJIFILM Pharmaceuticals U.S.A myelodysplastic syndromes Phase I/II
(cell differentiation stimulant) Valhalla, NJ www.fujifilmusa.com
Medicines in Development: Cancer ǀ 2018 54
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
flotetuzumab Macrogenics myelodysplastic syndromes Phase I
(CD123 and CD3 bispecific antibody) Rockville, MD www.macrogenics.com
Servier
Paris, France
FT-1101 FORMA Therapeutics relapsed/refractory hematologic Phase I
(BET inhibitor) Watertown, MA malignancies www.formatherapeutics.com
FT-2102 FORMA Therapeutics myelodysplastic syndromes with Phase I
Watertown, MA IDH1-mutation www.formatherapeutics.com
Gazyva® Genentech hematologic malignancies Phase I
obinutuzumab South San Francisco, CA (anti-CD20 combination therapy) www.gene.com
GSK3174998 GlaxoSmithKline hematologic malignancies Phase I
(anti-OX40 mAb) Research Triangle Park, NC www.gsk.com
GSK525762 (molibresib) GlaxoSmithKline hematologic malignancies Phase I
(BET inhibitor) Research Triangle Park, NC www.gsk.com
guadecitabine (SGI-110) Astex Pharmaceuticals myelodysplastic syndromes Phase III
(DNMT1 inhibitor) Pleasanton, CA www.astx.com
H3B-8800 Eisai myelodysplastic syndromes Phase I
(SF3B1 protein modulator) Woodcliff Lake, NJ www.eisai.com
H3 Biomedicine
Cambridge, MA
Medicines in Development: Cancer ǀ 2018 55
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
HDM201 Novartis Oncology hematologic malignancies Phase I
(p53-HDM2 inhibitor) East Hanover, NJ www.novartis.com
Hu5F9-G4 Forty Seven myelodysplastic syndromes, Phase I
(CD47 antigen inhibitor mAb) Menlo Park, CA myelodysplastic syndromes www.fortyseveninc.com
(+azacitidine)
idasanutlin (RG7388) Roche/Genentech polycythemia vera Phase II
(MDM2 antagonist) South San Francisco, CA www.gene.com
IGF-MTX IGF Oncology myelodysplastic syndromes Phase I/II
(IGF-methotrexate conjugate) St. Paul, MN www.igfoncology.com
Imbruvica® Janssen Research & Development hematologic malignancies Phase I/II
ibrutinib Raritan, NJ (+nivolumab) www.jansen.com
Pharmacyclics www.pharmacyclics.com
Sunnyvale, CA
Imfinzi® MedImmune myelodysplastic syndromes Phase I
durvalumab Gaithersburg, MD (+azacitidine) www.medimmne.com
Celgene myelodysplastic syndromes Phase II
Summit, NJ (post-hypomethylating agent failure) www.celgene.com
MedImmune
Gaithersburg, MD
Medicines in Development: Cancer ǀ 2018 56
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
IMG-7289 Imago BioSciences myelodysplastic syndromes Phase II
(LSD1 inhibitor) San Carlos, CA www.imagobio.com
myelofibrosis Phase I/II
www.imagobio.com
IMGN632 ImmunoGen hematologic malignancies Phase I
(anti-CD123 antibody-drug conjugate) Waltham, MA www.immunogen.com
IMMU-114 Immunomedics hematologic malignancies Phase I
(anti-HLA-DR) Morris Plains, NJ www.immunomedics.com
INCB54828 Incyte 8p11 myeloproliferative syndrome Phase II
(FGFR1/2/3 inhibitor) Wilmington, DE www.incyte.com
Jakafi® Incyte essential thrombocythemia Phase III
ruxolitinib Wilmington, DE www.incyte.com
ORPHAN DRUG
LCL161 Novartis Oncology post-essential thrombocytosis Phase II
(apoptosis protein inhibitor) East Hanover, NJ myelofibrosis, post-polycythemia www.novartis.com
myelofibrosis, primary myelofibrosis
Medicines in Development: Cancer ǀ 2018 57
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
luspatercept (ACE-536) Acceleron Pharma myelodysplastic syndromes Phase III
Cambridge, MA www.acceleron.com
Celgene www.celgene.com
Summit, NJ
myelofibrosis Phase II
www.acceleron.com
www.celgene.com
M7583 EMD Serono hematologic malignancies Phase I
(BTK inhibitor) Rockland, MA www.emdserono.com
MEDI7247 MedImmune hematologic malignancies Phase I
(immunomodulator) Gaithersburg, MD www.medimmune.com
MGD013 MacroGenics hematologic malignancies Phase I
(anti-PD-1 mAb x LAG-3) Rockville, MD www.macrogenics.com
MK-8628 Merck hematologic malignancies Phase I
(BET protein inhibitor) Kenilworth, NJ www.merck.com
momelotinib Gilead Sciences myelofibrosis, post-polycythemia vera, Phase II
(JAK 1/2 inhibitor) Foster City, CA post-essential thrombocythemia www.gilead.com
ORPHAN DRUG
napabucasin Boston Biomedical hematologic malignancies Phase I
(STAT3 inhibitor) Cambridge, MA (combination therapy) www.bostonbiomedical.com
Medicines in Development: Cancer ǀ 2018 58
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
navitoclax AbbVie myelofibrosis Phase II
(Bcl-1 inhibitor) North Chicago, IL www.abbvie.com
NiCord® Gamida-Cell high-risk hematologic malignancies Phase III
cord blood stem cell therapy Jerusalem, Israel www.gamida-cell.com
ORPHAN DRUG
NS-018 NS Pharma myelofibrosis Phase I/II
(JAK2 inhibitor) Paramus, NJ www.nspharma.com
OPB-111077 Otsuka Pharmaceutical hematologic malignancies Phase I
(signal transduction pathway inhibitor) Rockville, MD www.otsuka.com
OTS-167 OncoTherapy Science advanced myelodysplastic syndromes, Phase I/II
(MELK inhibitor) Kanagawa, China advanced myeloproliferative www.oncotherapy.co.jp
neoplastic disorders
OXi4503 Mateon Therapeutics myelodysplastic malignancies Phase I/II
(combretastatin A1 phosphate) South San Francisco, CA (+ cytarabine) www.mateon.com
pacritinib CTI BioPharma myelofibrosis (Fast Track) Phase III
(JAK2 inhibitor) Seattle, WA www.ctibiopharma.com
ORPHAN DRUG
pevonedistat Takeda Oncology high-risk myelodysplastic syndromes Phase III
(Nedd-activating enzyme inhibior) Deerfield, IL www.takeda.com
Medicines in Development: Cancer ǀ 2018 59
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
PIM447 Novartis Oncology myelofibrosis Phase I
(Pan-PIM inhibitor) East Hanover, NJ www.novartis.com
PLX51107 Plexxikon hematologic malignancies Phase I
(BET inhibitor) Berkeley, CA www.plexxikon.com
pracinostat MEI Pharma myelodysplastic syndromes Phase II
(hydroxamic inhibitor) San Diego, CA (+azacitidine) www.meipharma.com
PRM-151 Promedior myelofibrosis (Fast Track), Phase II
(cell differentiation modulator) Lexington, MA essential thrombocythemia, www.promedior.com
ORPHAN DRUG polycythemia vera
PU-H71 Samus Therapeutics myelofibrosis Phase I
(HSP90 inhibitor) Topsfield, MA www.samustherapeutics.com
relatlimab Bristol-Myers Squibb relapsed/refractory hematologic Phase II/III
(anti-LAG3 mAb) Princeton, NJ malignancies www.bms.com
RG6146 Roche/Genentech hematologic malignancies Phase I
(BET inhibitor) South San Francisco, CA www.gene.com
RG7828 Genentech hematologic malignancies Phase I
(anti-CD20/CD3 mAb) South San Francisco, CA (+/-atezolizumab) www.gene.com
Medicines in Development: Cancer ǀ 2018 60
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
rigosertib Onconova Therapeutics 2L higher-risk myelodysplastic Phase III
(PI3K/Plk1 inhibitor) Newtown, PA syndromes (intravenous) (Fast Track) www.onconova.com
ORPHAN DRUG
1L higher-risk myelodysplastic Phase II
syndromes (oral) www.onconova.com
ropeginterferon alfa-2b PharmaEssentia polycythemia vera Phase III
ORPHAN DRUG Taipei, Taiwan www.pharmaessentia.com
SL-401 Stemline Therapeutics blastic plasmacytoid dendritic cell application submitted
(recombinant fusion protein) New York, NY neoplasm (Breakthrough Therapy) www.stemline.com
ORPHAN DRUG
advanced, high-risk myeloproliferative Phase I/II
neoplasms www.stemline.com
SNX-5422 Esanex hematologic malignancies Phase I/II
(Hsp90 inhibitor) Indianapolis, IN www.esanexpharma.com
SRF231 Surface Oncology hematologic malignancies Phase I
(anti-CD47 mAb) Cambridge, MA www.surfaceoncology.com
SY-1425 Syros Pharmaceuticals myelodysplastic syndromes Phase I
(RAR-alpha agonist) Cambridge, MA (+ daratumumab) www.syros.com
Medicines in Development: Cancer ǀ 2018 61
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
Tecentriq® Genentech hematologic malignancies Phase I
atezolizumab South San Francisco, CA (+anti-CD20 combinations), www.gene.com
myelodysplastic syndromes
(+post-hypomethylating agent)
TEW-7197 MedPacto myelodysplastic syndromes Phase I/II
(TGF-beta antagonist) Suwon, South Korea www.medpacto.com
tinostamustine (EDO-S101) Mundipharma relapsed/refractory Phase I
(histone deacetylase inhibitor) Cambridge, United Kingdom hematologic malignancies www.mundipharma.com
tipifarnib Kura Oncology myelodysplastic syndromes Phase II
(farnesyltranstransferase inhibitor) San Diego, CA www.kuraoncology.com
tosedostat CTI BioPharma myelodysplastic syndromes Phase II
(aminopeptidases inhibitor) Seattle, WA www.ctibiopharma.com
TTI-621 Trillium Therapeutics hematologic malignancies Phase I
(CD47 inhibitors/SIRPA stimulant) Mississauga, Canada www.trilliumtherapeutics.com
UCART123 Cellectis blastic plasmacytoid Phase I
(CAR-T cell therapy) New York, NY dendritic cell neoplasm www.cellectis.com
vecabrutinib Sunesis Pharmaceuticals B-cell hematologic malignancies Phase I/II
(BTK inhibitor) South San Francisco, CA www.sunesis.com
Medicines in Development: Cancer ǀ 2018 62
Hematologic MalignanciesProduct Name Sponsor Indication Development Phase
Venclexta™ AbbVie myelodysplastic syndromes, Phase II
venetoclax North Chicago, IL 1L myelodysplastic syndromes www.abbvie.com
ORPHAN DRUG Genentech (+azacitidine) www.gene.com
South San Francisco, CA
relapsed/refractory myelodysplastic Phase I
syndromes (+azacitidine) www.abbvie.com
www.gene.com
Vyxeos® Jazz Pharmaceuticals myelodysplastic syndromes Phase II
daunorubicin and cytarabine Dublin, Ireland www.jazzpharma.com
WT-2725 Sunovion Pharmaceuticals hematologic malignancies Phase I
(peptide cancer vaccine) Marlborough, MA www.sunovion.com
XmAb13676 Xencor B-cell hematologic malignancies Phase I
(CD20 x CD3bispecific mAb) Monrovia, CA www.xencor.com
zanubrutinib (BGB-3111) BeiGene Waldenström's macroglobulinemia Phase III
(BTK inhibitor) Cambridge, MA www.beigene.com
ORPHAN DRUG
relapsed/refractory B-cell malignancies Phase I
www.beigene.com
Medicines in Development: Cancer ǀ 2018 63
Kidney CancerProduct Name Sponsor Indication Development Phase
abexinostat Xynomic Pharmaceuticals kidney cancer (+pazopanib) Phase III
(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com
AGS-16C3F Astellas renal cell carcinoma Phase II
(anti-ENPP3 antibody-drug conjugate) Northbrook, IL www.astellas.com
AM0010 ARMO Biosciences renal cell carcinoma (+PD-1) Phase I
(PEG-IL-10) Redwood City, CA www.armobio.com
Archexin® (RX-0201) Rexahn Pharmaceuticals metastatic renal cell carcinoma Phase II
Akt inhibitor Rockville, MD www.rexahn.com
ORPHAN DRUG
Bavencio® EMD Serono 1L renal cell carcinoma (+axitinib) Phase III
avelumab Rockland, MA (Breakthrough Therapy) www.emdserono.com
(anti-PD-L1 inhibitor) Pfizer www.pfizer.com
New York, NY
BMS-986205 Bristol-Myers Squibb advanced renal cell carcinoma Phase II
(IDO1 inhibitor) Princeton, NJ (+nivolumab +ipilimumab +relatlimab) www.bms.com
Cabometyx™ Exelixis 1L renal call carcinoma (+nivolumab) Phase III
cabozantinib South San Francisco, CA www.exelixis.com
1L or 2L papillary renal cell carcinoma Phase II
www.exelixis.com
Medicines in Development: Cancer ǀ 2018 64
Kidney CancerProduct Name Sponsor Indication Development Phase
camptothecin (CRLX101) BlueLink Pharmaceuticals metastatic renal cell carcinoma Phase II completed
ORPHAN DRUG Ames, IA (Fast Track)
CB-839 Calithera Biosciences renal cell carcinoma Phase II
(glutaminase inhibitor) South San Francisco, CA (+cabozantinib) (Fast Track), www.calithera.com
renal cell carcinoma
(+everolimus) (Fast Track)
CDX-014 Celldex Therapeutics renal cell carcinoma Phase I
(TIM-1 antibody-drug conjugate) Hampton, NJ www.celldex.com
Cotellic® Genentech renal cell carcinoma (+atezolizumab) Phase I
cobimetinib South San Francisco, CA www.gene.com
HBI-8000 HUYA Bioscience renal cell carcinoma Phase I/II
(HDAC inhibitor) San Diego, CA www.huyabio.com
ilixadencel Immunicum renal cell carcinoma Phase II
(dendritic cell vaccine) Gothenburg, Sweden www.immunicum.com
Keytruda® Merck renal cell carcinoma Phase III
pembrolizumab Kenilworth, NJ www.merck.com
LAG525 Novartis Oncology renal cell carcinoma (+PDR-001) Phase I/II
(anti-LAG3 mAb) East Hanover, NJ www.novartis.com
Medicines in Development: Cancer ǀ 2018 65
Kidney CancerProduct Name Sponsor Indication Development Phase
Lenvima® Eisai
lenvatinib Woodcliff Lake, NJ 1L renal cell carcinoma Phase III
www.eisai.com
Opdivo® Bristol-Myers Squibb 1L renal cell carcinoma (Fast Track) application submitted
nivolumab Princeton, NJ www.bms.com
PT2385 Peloton Therapeutics von Hippel-Landau disease Phase II
(HIF-1 alpha inhibitor) Dallas, TX associated renal cell carcinoma www.pelotontherapeutics.com
PT2977 Peloton Therapeutics von Hippel-Lindau disease Phase II
(HIF-2α inhibitor) Dallas, TX associated renal cell carcinoma www.pelotontherapeutics.com
rocapuldencel-T Argos Therapeutics 1L metastatic renal cell carcinoma Phase III
(personalised dendritic cell vaccine) Durham, NC (Fast Track) www.argostherapeutics.com
savolitinib AstraZeneca papillary renal cell carcinoma Phase III
(c-Met inhibitor) Wilmington, DE www.astrazeneca.com
Tecentriq® Genentech renal cell carcinoma (adjuvant), Phase III
atezolizumab South San Francisco, CA renal cell carcinoma (+bevacizumab) www.gene.com
tivozanib AVEO Oncology renal cell carcinoma Phase III
(VEGR antagonist) Cambridge, MA www.aveooncology.com
renal cell carcinoma (+nivolumab) Phase II
www.aveooncology.com
Medicines in Development: Cancer ǀ 2018 66
Kidney CancerProduct Name Sponsor Indication Development Phase
TRC-105 TRACON Pharmaceuticals renal cell carcinoma (Fast Track) Phase II
(carotuximab) San Diego, CA www.traconpharma.com
varlilumab Celldex Therapeutics renal cell carcinoma (+nivolumab) Phase II
(anti-CD28 mAb) Hampton, NJ www.celldex.com
X4P-001-IO X4 Pharmaceuticals refractory clear cell renal cell Phase I/II
(CXCR4 inhibitor) Cambridge, MA carcinoma www.x4pharma.com
LeukemiaProduct Name Sponsor Indication Development Phase
ABBV-744 AbbVie relapsed/refractory acute myeloid Phase I
(BRD2/3/4 inhibitor) North Chicago, IL leukemia (AML) www.abbvie.com
abexinostat Xynomic Pharmaceuticals AML (+ibrutinib) Phase II
(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com
ABL001 (asciminib) Novartis Oncology 3L chronic myeloid leukemia (CML) Phase III
(BCR-ABL inhibitor) East Hanover, NJ www.novartis.com
1L CML Phase II
www.novartis.com
Medicines in Development: Cancer ǀ 2018 67
LeukemiaProduct Name Sponsor Indication Development Phase
Actimab-A Actinium Pharmaceuticals newly-diagnosed AML in patients Phase II
lintuzumab Ac-225 New York, NY over age 60 www.actiniumpharma.com
ORPHAN DRUG
ADCT-301 (camidanlumab tesirine) ADC Therapeutics ALL, AML Phase I
(antibody-drug conjugate) Murray Hill, NJ www.adctherapeutics.com
ADCT-402 ADC Therapeutics B-cell ALL Phase I
(loncastuximab tesirine) Murray Hill, NJ www.adctherapeutics.com
AEB1102 Aeglea Biotherapeutics AML Phase I
(pegzilarginase) Austin, TX www.aegleabio.com
AG-881 Agios Pharmaceuticals AML Phase I
(pan-IDH inhibitor) Cambridge, MA www.celgene.com
Celgene
Summit, NJ
AGS62P1 Astellas AML Phase I
(anti-FLT3 antibody-drug conjugate) Northbrook, IL www.astellas.com
ALRN-6924 Aileron Therapeutics AML Phase I
(MDM2/MDMX antagonist) Cambridge, MA www.aileronrx.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 68
LeukemiaProduct Name Sponsor Indication Development Phase
alvocidib (DSP-2033) Tolero Pharmaceuticals MCL-1 dependent relapsed/refractory Phase II
(CDK9 inhibitor) Lehi, UT AML www.toleropharma.com
ORPHAN DRUG
newly-diagnosed AML Phase I
(combination therapy) www.toleropharma.com
AMG 176 Amgen relapsed/refractory AML Phase I
(MCL1 protein inhibitor) Thousand Oaks, CA www.amgen.com
AMG 330 Amgen relapsed/refractory AML Phase I
(anti-CD33 x anti-CD3 Thousand Oaks, CA www.amgen.com
bispecific T-cell engager)
AMG 673 Amgen relapsed/refractory AML Phase I
(anti-CD33 x anti-CD3 Thousand Oaks, CA www.amgen.com
bispecific T-cell engager)
AMV564 Amphivena Therapeutics relapsed/refractory AML Phase I
(anti-CD33 x anti-CD3 South San Francisco, CA www.amphivena.com
bispecific T-cell engager)
ORPHAN DRUG
annamycin liposomal Moleculin Biotech relapsed/refractory AML Phase I/II
(type II DNA topoisomerase inhibitor) Houston, TX www.moleculin.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 69
LeukemiaProduct Name Sponsor Indication Development Phase
anti-CD19 CAR-T cell therapy Intrexon leukemia Phase I
Germantown, MD www.intrexon.com
ZIOPHARM Oncology www.ziopharm.com
Boston, MA
anti-CD33 CAR-T cell therapy Intrexon AML Phase I
Germantown, MD www.ziopharm.com
ZIOPHARM Oncology
Boston, MA
AST-VAC1 Asterias Biotherapeutics AML Phase II
(telomerase-based cancer vaccine) Fremont, CA www.asteriasbiotherapeutics.com
ASTX727 Astex Pharmaceuticals chronic myelomonocytic leukemia Phase III
(DNMT inhibitor) Pleasanton, CA (CMML) www.astx.com
avapritinib Blueprint Medicines mast cell leukemia Phase I
(PDGFRa/KIT inhibitor) Cambridge, MA www.blueprintmedicines.com
ORPHAN DRUG
AVB-S6-500 Aravive Biologics AML Phase I
(GAS6-AXL pathway inhibitor) Houston, TX www.aravive.com
BAY1436032 Bayer Pharmaceuticals IDH1-mutant AML Phase I
(mutant-IDH1 inhibitor) Whippany, NJ www.pharma.bayer.com
Medicines in Development: Cancer ǀ 2018 70
LeukemiaProduct Name Sponsor Indication Development Phase
bemcentinib (BGB324) BerGenBio AML Phase I/II
(AXL kinase inhibitor) Bergen, Norway www.bergenbio.com
BI 836826 Boehringer Ingelheim Pharmaceuticals CLL Phase I/II
(anti-CD37 mAb) Ridgefield, CT www.boehringer-ingelheim.com
BI 836858 Boehringer Ingelheim Pharmaceuticals AML Phase II
(anti-CD33 mAb) Ridgefield, CT www.boehringer-ingelheim.com
ORPHAN DRUG
BNZ-1 Bioniz T-cell leukemia (large granular Phase II
(IL-2/IL-9/IL-15 receptor antagonist) Irvine, CA leukemia, cutaneous T-cell leukemia) www.bioniz.com
BPX-501 Bellicum Pharmaceuticals ALL (pediatric), AML Phase I/II
(rivogenlecleucel) Houston, TX www.bellicum.com
BPX-701 Bellicum Pharmaceuticals AML Phase I
(T-cell receptor therapy) Houston, TX www.bellicum.com
calaspargase pegol (SHP-633) Shire ALL application submitted
(pegylated L-asparaginase) Cambridge, MA www.shire.com
ORPHAN DRUG
Calquence® Acerta Pharma 1L chronic lymphocytic leukemia (CLL), Phase III
acalabrutinib South San Francisco, CA relapsed/refractory high-risk CLL www.astrazeneca.com
AstraZeneca
Wilmington, DE
Medicines in Development: Cancer ǀ 2018 71
LeukemiaProduct Name Sponsor Indication Development Phase
CC-122 (avadomide) Celgene CLL Phase I
(pleiotropic pathway modulator) Summit, NJ www.celgene.com
CC-486 Celgene post-induction AML (maintenance) Phase III
(oral azacitidine) Summit, NJ www.celgene.com
CC-90002 Celgene AML Phase I
(anti-CD47 antibody) Summit, NJ www.celgene.com
CC-90009 Celgene AML Phase I
(CELMoD) Summit, NJ www.celgene.com
CIK-CAR.CD19 Formula Pharmaceuticals relapsed or refractory ALL Phase I/II
(CIK-CAR-T cell therapy) Berwyn, PA www.formulapharma.com
cirmtuzumab Oncternal Therapeutics CLL Phase I/II
(ROR1 antagonist) San Diego, CA www.oncternal.com
CNDO-109 Fortress Biotech AML Phase I
(natural killer cell stimulant) New York, NY www.fortressbiotech.com
ORPHAN DRUG
cobomarsen miRagen Therapeutics CLL, T-cell lymphoma/leukemia Phase I
(microRNA inhibitor) Boulder, CO www.miragen.com
Medicines in Development: Cancer ǀ 2018 72
LeukemiaProduct Name Sponsor Indication Development Phase
CPI-0610 Constellation Pharmaceuticals AML Phase I/II
(BET protein inhibitor) Cambridge, MA www.constellationpharma.com
CPI-613 Rafael Pharmaceuticals relapsed/refractory AML Phase III
(altered energy metabolism- Newark, NJ (combination therapy) www.rafaelpharma.com
derived medicine)
ORPHAN DRUG
crenolanib AROG Pharmaceuticals AML (Fast Track) Phase II
(tyrosine kinase inhibitor) Dallas, TX www.arogpharmaceuticals.com
ORPHAN DRUG
CTL119 Novartis Oncology B-cell prolymphocytic leukemia, Phase I
(anti-CD19 CAR-T cell therapy) East Hanover, NJ precursor cell lymphoblastic www.novartis.com
University of Pennsylvania leukemia-lymphoma
Philadelphia, PA
CX-01 Cantex Pharmaceuticals AML Phase II
(dociparstat sodium) Weston, FL www.cantex.com
ORPHAN DRUG
DCLL9718S (RG6109) Genentech AML Phase I
South San Francisco, CA www.gene.com
DFP-10917 Delta-Fly Pharma ALL, AML Phase I/II
(cell cycle inhibitor) Tokushima, Japan www.delta-flypharma.co.jp
Medicines in Development: Cancer ǀ 2018 73
LeukemiaProduct Name Sponsor Indication Development Phase
DS-3201 Daiichi Sankyo ALL, AML Phase I
(EZH1/2 inhibitor) Basking Ridge, NJ www.dsi.com
DSP-7888 Sumitomo Dainippon Pharma relapsed/refractory AML Phase II
(adegramotide/nelatimotide) Osaka, Japan www.ds-pharma.com
DTRMWXHS 12 Zhejiang DTRM Biopharma CLL Phase I
(BTK inhibitor) Hangzhou, China
duvelisib Verastem relapsed/refractory CLL (Fast Track), application submitted
(PI3K delta/PI3K gamma inhibitor) Needham, MA relapsed/refractory small lymphocytic www.verastem.com
ORPHAN DRUG leukemia
relapsed/refractory CLL (post-BTK), Phase II
relapsed/refractory small lymphocytic www.verastem.com
(post-BTK)
entospletinib Gilead Sciences AML Phase II
(Syk inhibitor) Foster City, CA www.gilead.com
epratuzumab Immunomedics ALL (pediatric) Phase III
(anti-CD22 mAb) Morris Plains, NJ www.immunomedics.com
ORPHAN DRUG
eryaspase Erytech Pharma AML Phase II
(L-asparaginase ) Cambridge, MA www.erytech.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 74
LeukemiaProduct Name Sponsor Indication Development Phase
FATE-NK100 Fate Therapeutics AML Phase I
(natural killer cell stimulant) La Jolla, CA www.fatetherapeutics.com
FF-10101-01 FUJIFILM Pharmaceuticals U.S.A. AML Phase I
(FLT3 inhibitor) Cambridge, MA www.fujifilmusa.com
FF-10501-01 FUJIFILM Pharmaceuticals U.S.A. AML, CMML Phase I/II
(cell differentiation stimulant) Cambridge, MA www.fujifilmusa.com
ficlatuzumab AVEO Oncology AML Phase I
(HGF/c-Met inhibitor) Cambridge, MA www.aveooncology.com
flotetuzumab Macrogenics AML Phase I
(CD123 and CD3 bispecific antibody) Rockville, MD www.macrogenics.com
ORPHAN DRUG Servier
Paris, France
FT-2102 FORMA Therapeutics relapsed/refractory AML with Phase I
Watertown, MA IDH1-mutation www.formatherapeutics.com
galinpepimut-S Sellas Life Sciences AML (Fast Track) Phase II
(anti-WT1 peptide cancer vaccine) New York, NY www.sellaslifesciences.com
ORPHAN DRUG
CML, AML (+hypomethylating agent) Phase I
www.sellaslifesciences.com
Medicines in Development: Cancer ǀ 2018 75
LeukemiaProduct Name Sponsor Indication Development Phase
gilteritinib Astellas relapsed/refractory AML with application submitted
(FLT3/AXL inhibitor) Northbrook, IL FLT3-mutation (Fast Track) www.astellas.com
ORPHAN DRUG
relapsed/refractory AML, Phase III
AML (post-chemotherapy maintenance), www.astellas.com
AML (post-HSCT maintenance)
newly-diagnosed AML Phase II/III
(low-intensity chemotherapy) www.astellas.com
newly-diagnosed AML Phase I
(high-intensity chemotherapy) www.astellas.com
glasdegib Pfizer AML Phase II
(SMO antagonist) New York, NY www.pfizer.com
ORHAN DRUG
GLG-801 GLG Pharma CLL Phase I/II
(STAT3 inhibitor) Jupiter, FL www.glgpharma.com
GMI-1271 GlycoMimetics AML (Fast Track) Phase II
(uproleselan sodium) Rockville, MD www.glycomimetics.com
ORPHAN DRUG
GO-203-2c Genus Oncology AML Phase II
(MUC1-C inhibitor) Boston, MA www.genusoncology.com
Medicines in Development: Cancer ǀ 2018 76
LeukemiaProduct Name Sponsor Indication Development Phase
guadecitabine (SGI-110) Astex Pharmaceuticals AML, CMML Phase III
(DNMT1 inhibitor) Pleasanton, CA www.astx.com
ORPHAN DRUG
H3B-8800 Eisai AML, CMML Phase I
(SF3B1 protein modulator) Woodcliff Lake, NJ www.eisai.com
ORPHAN DRUG H3 Biomedicine
Cambridge, MA
HSV-Tk MolMed high risk acute leukemia Phase III
(nalotimagene carmaleucel) Milan, Italy www.molmed.com
ORPHAN DRUG
Hu5F9-G4 Forty Seven AML, AML (+azacitidine) Phase I
(CD47 antigen inhibitor mAb) Menlo Park, CA www.fortyseveninc.com
iC9/CAR.19/IL15-transduced CB-NK cells Bellicum Pharmaceuticals ALL, CLL Phase I/II
Houston, TX www.bellicum.com
M.D. Anderson Cancer Center
Houston, TX
idasanutlin (RG7388) Roche/Genentech AML (+chemotherapy) Phase III
(MDM2 antagonist) South San Francisco, CA www.gene.com
Idhifa® Agios Pharmaceuticals newly-diagnosed AML with Phase I
enasidenib Cambridge, MA IDH2-mutation www.celgene.com
Celgene
Summit, NJ
Medicines in Development: Cancer ǀ 2018 77
LeukemiaProduct Name Sponsor Indication Development Phase
IGF-MTX IGF Oncology CMML Phase I/II
(IGF-methotrexate conjugate) St. Paul, MN www.igfoncology.com
Imbruvica® Janssen Research & Development 1L CLL Phase III
ibrutinib Raritan, NJ www.janssen.com
Pharmacyclics www.pharmacyclics.com
Sunnyvale, CA
Imfinzi® Celgene AML Phase II
durvalumab Summit, NJ www.celgene.com
MedImmune
Gaithersburg, MD
IMG-7289 Imago BioSciences AML Phase II
(LSD1 inhibitor) San Carlos, CA www.imagobio.com
IMGN779 ImmunoGen AML Phase I
(anti-CD33 antibody-drug conjugate) Waltham, MA www.immunogen.com
INCB59872 Incyte AML Phase I/II
(LSD1 inhibitor) Wilmington, DE www.incyte.com
indoximod NewLink Genetics newly-diagnosed AML Phase I
(IDO inhibitor) Ames, IA www.newlinkgenetics.com
inecalcitol Hybrigenics AML Phase II
(calcitriol receptor agonist) Paris, France www.hybrigenics.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 78
LeukemiaProduct Name Sponsor Indication Development Phase
Iomab-B CD45 Actinium Pharmaceuticals induction and conditioning agent Phase III
(I-131-apamistamab) New York, NY prior to a bone marrow transplant www.actiniumpharma.com
ORPHAN DRUG for AML in patients over age 56
ivosidenib Agios Pharmaceuticals AML application submitted
(IDH1 inhibitor) Cambridge, MA www.agios.com
ORPHAN DRUG
JNJ-63709178 Janssen Research & Development relapsed/refractory AML Phase I
(CD123 x CD3 DuoBody® protein) Raritan, NJ www.janssen.com
KTE-C19 CAR-T cell therapy Kite Pharma ALL (pediatric and adult) Phase I
(second generation anti-CD19) Santa Monica, CA www.kitepharma.com
Kymriah™ Novartis Oncology ALL (pediatric/young adult) application submitted
tisagenlecleucel-T East Hanover, NJ www.novartis.com
(anti-CD19 CAT-T cell therapy)
CLL Phase III
www.novartis.com
LAM-003 LAM Therapeutics AML Phase I
(immunmodulator) Guilford, CT www.lamtherapeutics.com
lenzilumab Humanigen CMML Phase I
(anti-GM-CSF mAb) Brisbane, CA www.humanigen.com
Medicines in Development: Cancer ǀ 2018 79
LeukemiaProduct Name Sponsor Indication Development Phase
LY3039478 Eli Lilly T-cell ALL (combination therapy) Phase I/II
(NOTCH inhibitor) Indianapolis, IN www.lilly.com
MB-102 Mustang Bio AML Phase I
(CAR-T cell therapy) New York, NY www.mustangbio.com
ME-401 MEI Pharma CLL Phase I
(PI3K delta inhibitor) San Diego, CA www.meipharma.com
mivebresib (ABBV-075) AbbVie AML Phase I
(BET inhibitor) North Chicago, IL www.abbvie.com
monalizumab Innate Pharma CLL (combination therapy) Phase I/II
(NKG2A checkpoint receptor Marseille, France www.innate-pharma.com
antagonist)
MOR-208 (XmAb5574) MorphoSys B-cell CLL, CLL Phase II
(B-cell inhibitor mAb) Planegg, Germany www.morphosys.com
ORPHAN DRUG
moxetumomab pasudotox MedImmune hairy cell leukemia application submitted
(CD22 antigen inhibitor) Gaithersburg, MD www.medimmune.com
ORPHAN DRUG
3L hairy cell leukemia Phase III
www.medimmune.com
Medicines in Development: Cancer ǀ 2018 80
LeukemiaProduct Name Sponsor Indication Development Phase
MT-3724 Molecular Templates B-cell CLL Phase I
(engineered toxin bodies [ETB] Austin, TX www.mtem.com
targeting CD20)
ONC201 Oncoceutics leukemia Phase I/II
(dopamine receptor D2/3 antagonist) Philadelphia, PA www.oncoceutics.com
ONO-7475 Ono Pharmaceutical AML Phase I
(Axl/Mer inhibitor) Osaka, Japan www.ono.co.jp
Opdivo® Bristol-Myers Squibb CML Phase I
nivolumab Princeton, NJ www.bms.com
otlertuzumab Aptevo Therapeutics CLL (combination therapy) Phase II
(CD37 protein inhibitor) Seattle, WA www.aptevotherapeutics.com
ORPHAN DRUG
OTS-167 OncoTherapy Science ALL, refractory/relapsed AML, Phase I/II
(MELK inhibitor) Kanagawa, China advanced CML www.oncotherapy.co.jp
OXi4503 Mateon Therapeutics AML (+cytarabine) (Fast Track) Phase I/II
(combretastatin A1 phosphate) South San Francisco, CA www.mateon.com
ORPHAN DRUG
OXS-1550 GT Biopharma relapsed/refractory B-lineage leukemia Phase I/II
(bispecific scFv recombinant Washington, DC www.gtbiopharma.com
fusion protein-drug conjugate)
Medicines in Development: Cancer ǀ 2018 81
LeukemiaProduct Name Sponsor Indication Development Phase
PCM-075 TrovaGene AML Phase II
(PLK1 inhibitor) San Diego, CA www.trovagene.com
ORPHAN DRUG
pegargiminase Polaris Pharmaceuticals AML (+low-dose cytarabine) Phase I
(ADI-PEG-20) San Diego, CA www.polarispharma.com
pinometostat Epizyme MLL-R (rearranged) ALL, MLL-R AML Phase I
(DOT1L protein inhibitor) Cambridge, MA www.epizyme.com
ORPHAN DRUG
pracinostat MEI Pharma AML (+azacitidine) Phase III
(hydroxamic inhibitor) San Diego, CA www.meipharma.com
ORPHAN DRUG
prexigebersen Bio-Path Holdings AML, CML Phase II
(antisense cancer therapy) Houston, TX www.biopathholdings.com
ORPHAN DRUG
PTX-200 Prescient Therapeutics relapsed/refractory AML Phase I
(Akt inhibitor) South Melbourne, Australia www.ptxtherapeutics.com
quizartinib Daiichi Sankyo 1L/2L AML (Fast Track) Phase III
(FLT3 inhibitor) Basking Ridge, NJ www.dsi.com
ORPHAN DRUG
REGN1979 Regeneron Pharmaceuticals CLL Phase I
(anti-CD20/CD3 bispecific mAb) Tarrytown, NY www.regeneron.com
Medicines in Development: Cancer ǀ 2018 82
LeukemiaProduct Name Sponsor Indication Development Phase
rituximab biosimilar Allergan CLL Phase III
(ABP 798) Parsippany, NJ www.amgen.com
Amgen
Thousand Oaks, CA
rituximab biosimilar Celltrion CLL application submitted
Incheon, South Korea www.celltrion.com
rituximab biosimilar Sandoz CLL application submitted
(GP2013) Princeton, NJ www.sandoz.com
Rydapt® Novartis Oncology FLT3 wild type AML Phase III
midostaurin East Hanover, NJ www.novartis.com
sapacitabine Cyclacel Pharmaceuticals AML Phase III
(nucleoside analogue) Berkeley Heights, NJ www.cyclacel.com
ORPHAN DRUG
SEL24 Selvita AML Phase I/II
(PIM/FLT3 inhibitor) Krakow, Poland www.selvita.com
SGN-CD123A Seattle Genetics relapsed/refractory AML Phase I
(anti-CD123 antibody-drug conjugate) Bothell, WA www.seattlegenetics.com
SL-401 Stemline Therapeutics AML Phase I/II
(recombinant fusion protein) New York, NY www.stemline.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 83
LeukemiaProduct Name Sponsor Indication Development Phase
SNX-5422 Esanex CLL (+ibrutinib) Phase I
(Hsp90 inhibitor) Indianapolis, IN www.esanexpharma.com
Sprycel® Bristol-Myers Squibb CML (+nivolumab) Phase I
dasatinib Princeton, NJ www.bms.com
SUN-K0706 Sun Pharma Advanced Research CML Phase I
(tyrosine kinase inhibitor) Mumbai, India www.sparc.life
SY-1425 Syros Pharmaceuticals 1L AML (+ azacitidine), relapsed/ Phase I
(RAR-alpha agonist) Cambridge, MA refractory AML (+ daratumumab) www.syros.com
ORPHAN DRUG
Tecentriq® Genentech AML (+guadecitabine) Phase I
atezolizumab South San Francisco, CA www.gene.com
tipifarnib Kura Oncology CMML Phase II
(farnesyltranstransferase inhibitor) San Diego, CA www.kuraoncology.com
tosedostat CTI BioPharma AML Phase II
(aminopeptidases inhibitor) Seattle, WA www.ctibiopharma.com
ORPHAN DRUG
TPA Rich Pharmaceuticals AML Phase II
(tetradecanoylphorbol acetate) Beverly Hills, CA www.richpharmaceuticals.com
Medicines in Development: Cancer ǀ 2018 84
LeukemiaProduct Name Sponsor Indication Development Phase
ublituximab (TG-1101) TG Therapeutics high-risk CLL Phase III
(anti-CD20 mAb) New York, NY www.tgtherapeutics.com
ORPHAN DRUG
ublituximab + umbralisib TG Therapeutics CLL Phase III
(anti-CD20 mAb.PI3K inhibitor) New York, NY www.tgtherapeutics.com
UCART123 Cellectis AML Phase I
(CAR-T cell therapy) New York, NY www.cellectis.com
UCART19 Allogene Therapeutics B-cell ALL Phase I
(CAR-T cell therapy) South San Francisco, CA www.allogene.com
Servier
Paris, France
ulocuplumab Bristol-Myers Squibb newly-diagnosed AML Phase I/II
(anti-CXCR4 mAb) Princeton, NJ www.bms.com
umbralisib (TGR-1202) TG Therapeutics relapsed/refractory CLL Phase II
(PI3K inhibitor) New York, NY www.tgtherapeutics.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 85
LeukemiaProduct Name Sponsor Indication Development Phase
Venclexta™ AbbVie 1L CLL application submitted
venetoclax North Chicago, IL www.abbvie.com
ORPHAN DRUG Genentech www.gene.com
South San Francisco, CA
AML, relapsed/refractory CLL Phase III
www.abbvie.com
www.gene.com
AML (+ cobimetinib/idasanutlin) Phase I
www.abbvie.com
www.gene.com
vosaroxin Sunesis Pharmaceuticals AML (Fast Track) Phase II
(quinolone derivative) South San Francisco, CA www.sunesis.com
ORPHAN DRUG
XmAb14045 Xencor AML Phase I
(CD123 x CD3 bispecific mAb) Monrovia, CA www.xencor.com
zanubrutinib (BGB-3111) BeiGene 1L CLL Phase III
(BTK inhibitor) Cambridge, MA www.beigene.com
ORPHAN DRUG
Zydelig® Gilead Sciences relapsed/refractory CLL Phase III
idelalisib Foster City, CA www.gilead.com
Medicines in Development: Cancer ǀ 2018 86
Liver CancerProduct Name Sponsor Indication Development Phase
ABC294640 (Yeliva®) RedHill Biopharma advanced hepatocellular carcinoma, Phase II
(sphingosine kinase-2 inhibitor) Raleigh, NC cholangiocarcinoma www.redhillbio.com
ORPHAN DRUG
Ad-p53 MultiVir liver metastases Phase I
(gene therapy) Houston, TX www.multivir.com
AFP TCR Adaptimmune hepatocellular carcinoma Phase I
(alpha fetoprotein targeted Philadelphia, PA www.adaptimmune.com
T-cell therapy)
amcasertib (BBI503) Boston Biomedical hepatocellular carcinoma Phase I/II
(cancer cel [stemness] inhibitor) Cambridge, MA (combination therapy) www.bostonbiomedical.com
anti-CEA CAR-T cell therapy Sorrento Therapeutics metastatic liver cancer Phase I
San Diego, CA www.sorrentotherapeutics.com
BLU-554 Blueprint Medicines advanced hepatocellular carcinoma Phase I
(FGFR4 kinase inhibitor) Cambridge, MA www.blueprintmedicines.com
ORPHAN DRUG
BMS-986183 Bristol-Myers Squibb hepatocellular carcinoma Phase I/II
Princeton, NJ www.bms.com
Medicines in Development: Cancer ǀ 2018 87
Liver CancerProduct Name Sponsor Indication Development Phase
Cabometyx™ Exelixis 2L and later-line advanced application submitted
cabozantinib South San Francisco, CA hepatocellular carcinoma www.exelixis.com
ORPHAN DRUG
1L and previously treated advanced Phase I/II
hepatocellular carcinoma www.exelixis.com
(+nivolumab +/-ipilimumab)
capmatinib (INC280) Novartis Oncology hepatocellular carcinoma Phase I/II
(c-Met inhibitor) East Hanover, NJ www.novartis.com
Incyte
Wilmington, DE
Cavatak® Viralytics uveal melanoma metastatic Phase I
coxsackievirus Sydney, Australia to the liver (+ipilimumab) www.viralytics.com
CC-122 (avadomide) Celgene hepatocellular carcinoma Phase I
(pleiotropic pathway modulator) Summit, NJ www.celgene.com
codrituzumab (RG7686) Roche/Genentech hepatocellular carcinoma Phase II
(glypican 3 inhibitor) South San Francisco, CA www.roche.com
Cyramza® Eli Lilly hepatocellular carcinoma Phase III
ramucirumab Indianapolis, IN www.lilly.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 88
Liver CancerProduct Name Sponsor Indication Development Phase
derazantinib (ARQ 087) ArQule intrahepatic cholangiocarcinoma Phase III
(FGFR antagonist) Burlington, MA www.arqule.com
ORPHAN DRUG Basilea Pharmaceutica
Basel, Switzerland
DKN-01 Leap Therapeutics biliary tract cancer Phase I/II
(anti-DKK1 mAb) Cambridge, MA (combination therapy) www.leaptx.com
eFT508 eFFECTOR Therapeutics hepatocellular carcinoma Phase II
(MKNK1/MKNK2 protein inhibitor) San Diego, CA www.effector.com
ENMD-2076 CASI Pharmaceuticals fibrolamellar liver cancer Phase II
(mulitple kinase inhibitor) Rockville, MD www.casipharmaceuticals.com
ORPHAN DRUG
FGF401 Novartis Oncology hepatocellular carcinoma Phase I/II
(FGFR4 antagonist) East Hanover, NJ www.novartis.com
galunisertib Eli Lilly recurrent/refractory hepatocellular Phase I/II
(TGF-beta 1 inhibitor) Indianapolis, IN carcinoma (+nivolumab) www.lilly.com
H3B-6527 Eisai advanced hepatocellular carcinoma Phase I
(FGFR4 inhibitor) Woodcliff Lake, NJ www.h3biomedicine.com
ORPHAN DRUG H3 Biomedicine
Cambridge, MA
Medicines in Development: Cancer ǀ 2018 89
Liver CancerProduct Name Sponsor Indication Development Phase
Imfinzi® MedImmune 1L hepatocellular carcinoma Phase III
durvalumab Gaithersburg, MD (+tremelimumab) www.medimmune.com
biliary tract cancer (+tremelimumab) Phase II
www.medimmune.com
Imlygic® Amgen hepatocellular carcinoma Phase I
talimogene laherparepvec Thousand Oaks, CA (+pembrolizumab) www.amgen.com
(oncolytic virus therapy)
INCB54828 Incyte cholangiocarcinoma Phase II
(FGFR1/2/3 inhibitor) Wilmington, DE www.incyte.com
INCB62079 Incyte liver cancer Phase I/II
(FGFR4 inhibitor) Wilmington, DE www.incyte.com
infigratinib (BGJ398) QED Therapeutics chemo-refractory cholangiocarcinoma Phase II
(FGFR inhibitor) Palo Alto, CA with FGFR-fusions www.qedtx.com
ivosidenib Agios Pharmaceuticals cholangiocarcinoma (Fast Track) Phase III
(IDH1 inhibitor) Cambridge, MA www.agios.com
ORPHAN DRUG
Keytruda® Merck hepatocellular carcinoma Phase III
pembrolizumab Kenilworth, NJ www.merck.com
Medicines in Development: Cancer ǀ 2018 90
Liver CancerProduct Name Sponsor Indication Development Phase
Lenvima® Eisai hepatocellular carcinoma application submitted
lenvatinib Woodcliff Lake, NJ www.eisai.com
ORPHAN DRUG
hepatocellular (+pembrolizumab) Phase I
www.eisai.com
melphalan drug delivery system Delcath Systems hepatic-dominant ocular melanoma Phase III
ORPHAN DRUG New York, NY (liver metastases) (Fast Track), www.delcath.com
intrahepatic cholangiocarcinoma
merestinib Eli Lilly biliary tract cancer Phase II
(type II multikinase inhibitor) Indianapolis, IN www.lilly.com
namodenoson (CF102) Can-Fite BioPharma hepatocellular carcinoma (Fast Track) Phase II
(A3AR agonist) Petah-Tikva, Israel www.canfite.com
ORPHAN DRUG
napabucasin Boston Biomedical hepatocellular carcinoma (+sorafenib) Phase I/II
(STAT3 inhibitor) Cambridge, MA www.bostonbiomedical.com
NC-6004 NanoCarrier biliary tract liver (+gemcitabine) Phase II
(cisplatin micellar nanoparticle) Chiba, Japan www.nanocarrier.co.jp
ORPHAN DRUG
pegargiminase Polaris Pharmaceuticals hepatocellular carcinoma (+FOLFOX) Phase I/II
(ADI-PEG-20) San Diego, CA www.polarispharma.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 91
Liver CancerProduct Name Sponsor Indication Development Phase
pexastimogene devacirepvec (Pexa-Vec) SillaJen Biotherapeutics hepatocellular carcinoma Phase III
(genetically-engineered Busan, South Korea www.sillajen.com
oncolytic vaccinia poxvirus)
ORPHAN DRUG
PV-10 Provectus Biopharmaceuticals cancer metastatic to the liver Phase I
(rose bengal sodium) Knoxville, TN www.provectusbio.com
ORPHAN DRUG
SF1126 SignalRx Pharmaceuticals hepatocellular carcinoma Phase I
(PI3K/mTOR inhibitor) San Diego, CA www.signalrx.com
silmitasertib (CX-4945) Senhwa Biosciences cholangiocarcinoma Phase I/II
(casein kinase II inhibitor) New Taipei City, Taiwan (combination therapy) www.senhwabiosciences.com
ORPHAN DRUG
Tecentriq® Genentech 1L hepatocellular carcinoma Phase III
atezolizumab South San Francisco, CA (+bevacizumab) www.gene.com
hepatocellular carcinoma Phase I
(+bevacizumab +chemotherapy) www.gene.com
tepotinib EMD Serono hepatocellular carcinoma Phase II
(c-Met kinase inhibitor) Rockland, MA www.emdserono.com
Medicines in Development: Cancer ǀ 2018 92
Liver CancerProduct Name Sponsor Indication Development Phase
ThermoDox® Celsion hepatocellular carcinoma (Fast Track) Phase III
doxorubicin liposomal Lawrenceville, NJ www.celsion.com
ORPHAN DRUG
tirapazamine (TPZ) Teclison hepatocellular carcinoma Phase II
(type II DNA topoisomerase inhibitor) Taipei, Taiwan www.teclison.com
tislelizumab (BGB-A317) BeiGene USA hepatocellular carcinoma Phase III
(anti-PD-1 mAb) Cambridge, MA www.beigene.com
Celgene www.celgene.com
Summit, NJ
TRC-105 TRACON Pharmaceuticals hepatocellular carcinoma Phase II
(carotuximab) San Diego, CA www.traconpharma.com
varlitinib ASLAN Pharmaceuticals metastatic biliary tract cancer Phase II/III
(pan-HER inhibitor) Singapore www.aslanpharma.com
ORPHAN DRUG
VT-122 Vicus Therapeutics hepatocellular carcinoma Phase II
(propranolol/etodolac combination) Morristown, NJ www.vicusrx.com
Lung CancerProduct Name Sponsor Indication Development Phase
AC0010 ACEA Biosciences mutant-EGFR non-small cell Phase I
(EGFR inhibitor) San Diego, CA lung cancer (NSCLC) www.aceabio.com
Medicines in Development: Cancer ǀ 2018 93
Lung CancerProduct Name Sponsor Indication Development Phase
ADXS-NEO Advaxis metastatic NSCLC Phase I
(neoepitope-based Princeton, NJ www.advaxis.com
immunotherapy vaccine) Amgen
Thousand Oaks, CA
AEB1102 Aeglea Biotherapeutics SCLC (+pembrolizumab) Phase I/II
(pegzilarginase) Austin, TX www.aegleabio.com
AGEN1884 Agenus NSCLC (+pembrolizumab) Phase II
(CTLA-4 antagonist) Lexington, MA www.agenus.com
aglatimagene besadenovec Advantagene NSCLC (combination therapy) Phase I
(gene therapy) Auburndale, MA www.advantagene.com
aldoxorubicin CytRx 2L small cell lung cancer (SCLC) Phase II
ORPHAN DRUG Los Angeles, CA www.cytrx.com
NantKwest
Culver City, CA
ALT-803 Altor BioScience NSCLC (combination therapy) Phase II
(IL-15 superagonist protein complex) Miramar, FL www.altorbioscience.com
NantKwest
Culver City, CA
Alunbrig® Takeda 1L ALK-positive NSCLC Phase III
brigatinib Northbrook, IL www.takeda.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 94
Lung CancerProduct Name Sponsor Indication Development Phase
AM0010 ARMO Biosciences NSCLC (+PD-1) Phase I
(PEG-IL-10) Redwood City, CA www.armobio.com
amatuximab (MORAb-009) Eisai mesothelioma Phase II
(IgG1 mAb) Woodcliff Lake, NJ www.eisai.com
ORPHAN DRUG
AMG 757 Amgen SCLC Phase I
bispecific T-cell engager) Thousand Oaks, CA www.amgen.com
anetumab ravtansine Bayer Pharmaceuticals 2L malignant pleural mesothelioma Phase II
(antibody-drug conjugate) Whippany, NJ www.pharma.bayer.com
ORPHAN DRUG
antroquinonol Golden Biotechnology NSCLC Phase II
ORPHAN DRUG New Taipei City, Taiwan www.goldenbiotech.com
APG-1252 Ascentage Pharma SCLC Phase I
(Bcl-2/Bcl-xl inhibitor) Rockville, MD en.ascentagepharma.com
APX005M Apexigen NSCLC (+nivolumab) Phase I/II
(CD40 agonistic antibody) San Carlos, CA www.apexigen.com
Medicines in Development: Cancer ǀ 2018 95
Lung CancerProduct Name Sponsor Indication Development Phase
Bavencio® EMD Serono 1L NSCLC, 2L NSCLC Phase III
avelumab Rockland, MA www.emdserono.com
(anti-PD-L1 inhibitor) Pfizer www.pfizer.com
New York, NY
NSCLC (+4-1BB), SCLC (+4-1BB) Phase II
www.emdserono.com
www.pfizer.com
bemcentinib (BGB324) BerGenBio NSCLC (+pembrolizumab) Phase II
(AXL kinase inhibitor) Bergen, Norway www.bergenbio.com
NSCLC Phase I/II
www.bergenbio.com
bevacizumab biosimilar Boehringer Ingelheim Pharmaceuticals NSCLC Phase III
(BI 695502) Ridgefield, CT www.boehringer-ingelheim.com
bevacizumab biosimilar Pfizer NSCLC Phase III
(PF-06439536) New York, NY www.pfizer.com
BI 1361849 (CV-9202) Boehringer Ingelheim Pharmaceuticals NSCLC Phase II
(RNA cancer vaccine) Ridgefield, CT www.boehringer-ingelheim.com
BIO-11006 BioMarck Pharmaceuticals NSCLC Phase II
(MARCKS inhibitor) Durham, NC www.biomarck.com
Medicines in Development: Cancer ǀ 2018 96
Lung CancerProduct Name Sponsor Indication Development Phase
BLU-667 Blueprint Medicines NSCLC Phase I
(RET inhibitor) Cambridge, MA www.blueprintmedicines.com
BMS-986012 Bristol-Myers Squibb SCLC Phase I/II
(anti-fucosyl-GM1 mAb) Princeton, NJ www.bms.com
BMS-986205 Bristol-Myers Squibb advanced NSCLC Phase II
(IDO1 inhibitor) Princeton, NJ (immunotherapy combinations) www.bms.com
Cabometyx™ Exelixis EGFR wild type NSCLC Phase II
cabozantinib South San Francisco, CA www.exelixis.com
NSCLC (+atezolizumab) Phase I
www.exelixis.com
camptothecin (CRLX101) BlueLink Pharmaceuticals NSCLC Phase II completed
ORPHAN DRUG Ames, IA
canakinumab Novartis Oncology 1L NSCLC, 2L NSCLC, NSCLC (adjuvant) Phase III
East Hanover, NJ www.novartis.com
capmatinib (INC280) Novartis Oncology NSCLC Phase III
(c-Met inhibitor) East Hanover, NJ www.novartis.com
Incyte
Wilmington, DE
EGFR-mutated NSCLC Phase II
www.novartis.com
Medicines in Development: Cancer ǀ 2018 97
Lung CancerProduct Name Sponsor Indication Development Phase
Cavatak® Viralytics NSCLC (+pembrolizumab) Phase I
coxsackievirus Sydney, Australia www.viralytics.com
CD40LGVAX Cellular Biomedicine advanced NSCLC Phase II
Cupertino, CA www.cellbiomedgroup.com
cemiplimab Regeneron Pharmaceuticals 1L NSCLC Phase III
(anti-PD-1 mAb) Tarrytown, NY www.sanofi.com
Sanofi
Bridgewater, NJ
CK-101 Checkpoint Therapeutics NSCLC Phase I/II
(EGFR inhibitor) New York, NY www.checkpointtx.com
ORPHAN DRUG
CMP-001 Checkmate Pharmaceuticals NSCLC (+atezolizumab) Phase I
(TLR9 agonist cancer vaccine) Cambridge, MA www.checkmatepharma.com
CV-301 Bavarian Nordic NSCLC (+ anti-PD-1) Phase II
(CEA-MUC-1-TRICOM cancer vaccine) Morrisville, NC www.bavarian-nordic.com
Cyramza® Eli Lilly NSCLC Phase III
ramucirumab Indianapolis, IN www.lilly.com
dacomitinib Pfizer 1L EGFR-activating mutant NSCLC application submitted
(pan-HER inhibitor) New York, NY www.pfizer.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 98
Lung CancerProduct Name Sponsor Indication Development Phase
defactinib Verastem NSCLC (+pembrolizumab) Phase II
(FAK inhibitor) Needham, MA www.verastem.com
ORPHAN DRUG
mesothelioma (+pembrolizumab) Phase I
www.verastem.com
DKN-01 Leap Therapeutics NSCLC Phase I
(anti-DKK1 mAb) Cambridge, MA www.leaptx.com
DPV-001 UbiVac NSCLC (adjuvant therapy) Phase II
(autophagosome-enriched vaccine) Portland, OR www.ubivac.com
DS-1062 Daiichi Sankyo NSCLC Phase I
(anti-TROP2 antibody-drug conjugate) Basking Ridge, NJ www.dsi.com
DS-1205 Daiichi Sankyo EGFR-mutant NSCLC Phase I
(AXL inhibitor) Parsippany, NJ www.dsi.com
DV281 Dynavax NSCLC Phase I
(TLT9 agonist) Berkeley, CA www.dynavax.com
ensartinib Xcovery ALK-positive NSCLC Phase III
(ALK inhibitor) Palm Beach Gardens, FL www.xcovery.com
entinostat Syndax Pharmaceuticals NSCLC (+pembrolizumab) Phase II
(HDAC inhibitor) Waltham, MA www.syndax.com
Medicines in Development: Cancer ǀ 2018 99
Lung CancerProduct Name Sponsor Indication Development Phase
entrectinib Ignyta ROS1-positive NSCLC Phase II
(panTRK/ROS1 inhibitor) San Diego, CA www.ignta.com
ORPHAN DRUG
epacadostat Incyte NSCLC (+pembrolizumab) Phase III
(IDO1 inhibitor) Wilmington, DE www.incyte.com
lung cancer Phase I
www.incyte.com
G1T38 G1 Therapeutics EGFR metastatic NSCLC Phase II
(CDK4/6 inhibitor) Research Tringle Park, NC www.g1therapeutics.com
galinpepimut-S Sellas Life Sciences malignant pleural mesothelioma Phase II
(anti-WT1 peptide cancer vaccine) New York, NY (Fast Track) www.sellaslifesciences.com
ORPHAN DRUG
galunisertib Eli Lilly recurrent/refractory NSCLC Phase I/II
(TGF-beta 1 inhibitor) Indianapolis, IN (+nivolumab) www.lilly.com
Gilotrif® Boehringer Ingelheim Pharmaceuticals squamous cell of the lung Phase II
afatinib Ridgefield, CT (+pembrolizumab) www.boehringer-ingelheim.com
glesatinib (MGCD265) Mirati Therapeutics NSCLC Phase II
(multi-kinase inhibitor) San Diego, CA www.mirati.com
Medicines in Development: Cancer ǀ 2018 100
Lung CancerProduct Name Sponsor Indication Development Phase
GRN-1201 BrightPath Biotherapeutics NSCLC (+checkpoint inhibitor) Phase II
(cancer peptide vaccine) Tokyo, Japan www.nrightpathbio.com
GSK3377794 GlaxoSmithKline NSCLC Phase II
(NY-ESO-autologous engineered Research Triangle Park, NC www.gsk.com
T-cell receptor therapy)
HBI-8000 HUYA Bioscience NSCLC Phase I/II
(HDAC inhibitor) San Diego, CA www.huyabio.com
HS-10296 Jiangsu Hansoh Pharmaceutical NSCLC Phase I/II
Jiangsi, China www.hansoh.cn
IMA201 Immatics US squamous cell NSCLC Phase I
(adoptive T-cell therapy) Houston, TX www.immatics.com
Imfinzi® MedImmune 1L NSCLC (+tremelimumab), Phase III
durvalumab Gaithersburg, MD 1L NSCLC (+tremelimumab +chemo), www.medimmune.com
stage III NSCLC (monotherapy),
1L SCLC (+tremelimumab +SoC)
NSCLC (+RT), SCLC (+RT), Phase I
1L SCLC (+tremelimumab +chemo) www.medimmune.com
NSCLC (+gefitinib)
Imprime PGG® Biothera Pharmaceuticals NSCLC (+pembrolizumab) Phase I/II
immunostimulant PGG glucan Eagan, MN www.biothera.com
Medicines in Development: Cancer ǀ 2018 101
Lung CancerProduct Name Sponsor Indication Development Phase
INCB59872 Incyte SCLC Phase I/II
(LSD1 inhibitor) Wilmington, DE www.incyte.com
IPI-549 Infinity Pharmaceuticals mesothelioma (+nivolumab), Phase I
(PI3K-gamma inhibitor) Cambridge, MA NSCLC (+nivolumab) www.infi.com
IRX4204 Io Therapeutics NSCLC Phase II
(RXR agonist) Santa Ana, CA www.io-therapeutics.com
itacitinib Incyte NSCLC (+ osimertinib) Phase II
(JAK1 inhibitor) Wilmington, DE www.incyte.com
JNJ-61186372 Janssen Research & Development NSCLC Phase I
(EGFR/c-Met DuoBody® protein) Raritan, NJ www.janssen.com
JNJ-64041757 (ADU-214) Aduro Biotech adenocarcinoma of the lung Phase I/II
(Listeria monocytogenes Berkeley, CA www.aduro.com
immunotherapy vaccine) Janssen Research & Development www.janssen.com
Raritan, NJ
Keytruda® Merck SCLC Phase III
pembrolizumab Kenilworth, NJ www.merck.com
Kyprolis® Amgen SCLC Phase I/II
carfilzomib Thousand Oaks, CA www.amgen.com
Medicines in Development: Cancer ǀ 2018 102
Lung CancerProduct Name Sponsor Indication Development Phase
LAG525 Novartis Oncology NSCLC (+PDR001) Phase I/II
(anti-LAG3 mAb) East Hanover, NJ www.novartis.com
L-DOS47 Helix BioPharma recurrent or metastatic squamous Phase II
(tumor defense breaker) Toronto, Canada NSCLC www.helixbiopharma.com
Lenvima® Eisai NSCLC (RET translocations) Phase II
lenvatinib Woodcliff Lake, NJ www.eisai.com
LMB-100 Selecta Biosciences mesothelioma Phase I
(recombinant immunotoxin) Watertown, MA www.selectabio.com
LN-145 Iovance Biotherapeutics NSCLC (+/-durvalumab) Phase II
(tumor-infiltrating lymphocyte) San Carlos, CA www.iovance.com
lorlatinib (PF-06463922) Pfizer 1L ALK NSCLC Phase III
(ALK inhibitor) New York, NY www.pfizer.com
ORPHAN DRUG
2L ALK NSCLC (Breakthrough Therapy) Phase II
www.pfizer.com
lurbinectedin (PM1183) PharmaMar 2L SCLC Phase III
(RNA polymerase II inhibitor) Madrid, Spain www.pharmamar.com
LXH254 Novartis Oncology NSCLC (+LTT462), Phase I
(Raf kinase inhibitor) East Hanover, NJ NSCLC (+trametinib) www.novartis.com
Medicines in Development: Cancer ǀ 2018 103
Lung CancerProduct Name Sponsor Indication Development Phase
LYC-55716 Lycera NSCLC Phase I
(ROR-gamma agonist) Ann Arbor, MI www.lycera.com
MABp1 XBiotech NSCLC Phase II
Austin, TX www.xbiotech.com
MAGE-A10 TCR Adaptimmune NSCLC Phase I/II
(T-cell receptor therapy) Philadelphia, PA www.adaptimmune.com
MM-121 (seribantumab) Merrimack Pharmaceuticals NSCLC (Fast Track) Phase II
(anti-HER3 mAb) Cambridge, MA www.merrimack.com
ORPHAN DRUG
mocetinostat Mirati Therapeutics NSCLC (+durvalumab), Phase II
(HDAC inhibitor) San Diego, CA NSCLC (+pembrolizumab www.mirati.com
+guadecitabine)
MORAb-009 Eisai mesothelioma Phase II
Woodcliff Lake, NJ www.eisai.com
MP0250 Molecular Partners EGFR-mutated NSCLC (+osimertinib) Phase I/II
(angiogenesis / VEGF-A / HGF inhibitor) Zurich, Switzerland www.molecularpartners.com
MV-NIS Vyriad NSCLC (+atezolizumab) Phase I
(oncolytic viruse cancer vaccine) Rochester, MN www.vyriad.com
Medicines in Development: Cancer ǀ 2018 104
Lung CancerProduct Name Sponsor Indication Development Phase
nazartinib (EGF816) Novartis Oncology NSCLC Phase III
(EGFR mutation modulator) East Hanover, NJ www.novartis.com
NC-6004 NanoCarrier NSCLC (+ gemcitabine) Phase II
(cisplatin micellar nanoparticle) Chiba, Japan www.nanocarrier.co.jp
NEO-PV-01 Neon Therapeutics NSCLC Phase I
(personal neoantigen vaccine) Cambridge, MA www.neontherapeutics.com
NGR-hTNF MolMed malignant pleural mesothelioma Phase III completed
(recombinant fusion protein) Milan, Italy www.molmed.com
ORPHAN DRUG
Ofev® Boehringer Ingelheim Pharmaceuticals mesothelioma Phase III
nintedanib Ridgefield, CT www.boehringer-ingelheim.com
ORPHAN DRUG
Oncoprex™ Genprex NSCLC (+ erlotinib) Phase II
gene therapy Austin, TX www.genprex.com
Onivyde® Ipsen Biopharmaceuticals 2L SCLC Phase II
irinotecan liposome injection Basking Ridge, NJ www.ipsen.com
Opdivo® Bristol-Myers Squibb 1L NSCLC (Fast Track), SCLC, Phase III
nivolumab Princeton, NJ malignant pleural mesothelioma www.bms.com
Medicines in Development: Cancer ǀ 2018 105
Lung CancerProduct Name Sponsor Indication Development Phase
Opdivo® + Yervoy® Bristol-Myers Squibb NSCLC, SCLC, malignant pleural Phase III
nivolumab + ipilimumab Princeton, NJ mesothelioma www.bms.com
OSE-2101 OSE Immunotherapeutics NSCLC Phase III
(neo-epitopes cancer vaccine) Nantes, France www.ose-immuno.com
ORPHAN DRUG
PBF-1129 Palobiofarma NSCLC Phase I
(adenosine A2B receptor antagonist) Barcelona, Spain www.palobiofarma.com
PBF509 Novartis Oncology NSCLC (+PDR001) Phase I/II
(adenosine A2A receptor antagonist) East Hanover, NJ www.novartis.com
Palobiofarma
Barcelona, Spain
PDT with Photofrin® Pinnacle Biologics NSCLC Phase I
porfimer sodium Chicago, IL www.pinnaclebiologics.com
pegargiminase Polaris Pharmaceuticals mesothelioma (+pemetrexed +cisplatin) Phase II/III
(ADI-PEG-20) San Diego, CA www.polarispharma.com
ORPHAN DRUG
PEGPH20 Halozyme Therapeutics NSCLC (+pembrolizumab) Phase I
(pegylated recombinant San Diego, CA cholangiocarcinoma (+atezolizumab) www.halozyme.com
human hyalurinodase)
pemetrexed Apotex mesothelioma, NSCLC application submitted
Weston, FL www.apotex.com
Medicines in Development: Cancer ǀ 2018 106
Lung CancerProduct Name Sponsor Indication Development Phase
Pemfexy™ Eagle Pharmaceuticals mesothelioma (+cisplatin), NSCLC application submitted
pemetrexed injection Woodcliff Lake, NJ www.eagleus.com
PEN-221 Tarveda Therapeutics SCLC Phase I/II
(somatostatin receptor 2 modulator) Watertown, MA www.tarveda.com
plinabulin BeyondSpring Pharmaceuticals 2L/3L NSCLC (+docetaxel) Phase III
(guanine nucleotide exchange New York, NY www.beyondspringpharma.com
factor stimulant)
poziotinib Spectrum Pharmaceuticals NSCLC Phase II
(pan-HER/tyrosine kinase inhibitor) Henderson, NV www.sppirx.com
prexasertib Eli Lilly SCLC Phase II
(CHK1 inhibitor) Indianapolis, IN www.lilly.com
PT 107 Pique Therapeutics NSCLC Phase II
(allogeneic B7.1/HLA-A1 Durham, NC www.piquetherapeutics.com
cancer vaccine)
Rova-T AbbVie 1L SCLC, 2L SCLC Phase III
(rovalpituzumab tesirine) North Chicago, IL www.abbvie.com
ORPHAN DRUG
3L SCLC Phase II
www.abbvie.com
Medicines in Development: Cancer ǀ 2018 107
Lung CancerProduct Name Sponsor Indication Development Phase
RRx-001 EpicentRx NSCLC, SCLC Phase II
(free radical stimulant) La Jolla, CA www.epicentrx.com
sacituzumab govitecan Immunomedics metastatic lung cancer Phase II
(anti-TROP-2-SN-38 ADC) Morris Plains, NJ www.immunomedics.com
SC-002 AbbVie SCLC Phase I
(antibody-drug conjugate) North Chicago, IL www.abbvie.com
SEL-403 Selecta Biosciences mesothelioma Phase I
(recombinant immunotoxin + Watertown, MA www.selectabio.com
SVP-rapamycin)
sitravatinib (MGCD516) Mirati Therapeutics NSCLC (+nivolumab) Phase II
(multi kinase inhibitor) San Diego, CA www.mirati.com
SNX-5422 Esanex NSCLC Phase I
(Hsp90 inhibitor) Indianapolis, IN www.esanexpharma.com
Tagrisso® AstraZeneca 1L advanced EGFR-mutated NSCLC, Phase III
osimertinib Wilmington, DE EGFR-mutated NSCLC (adjuvant) www.astrazeneca.com
CNS metastases in advanced Phase II
EGFR-mutant NSCLC, www.astrazeneca.com
advanced EGFR-mutated NSCLC
(+selumetinib or savolitinib)
Medicines in Development: Cancer ǀ 2018 108
Lung CancerProduct Name Sponsor Indication Development Phase
TAK-788 (AP32788) Takeda Oncology NSCLC Phase I
(EGFR/HER2 inhibitor) Cambridge, MA www.takeda.com
TAS-114 Taiho Oncology NSCLC Phase II
(dUTPase inhibitor) Princeton, NJ www.taihooncology.com
Tavocept® BioNumerik Pharmaceuticals primary adenocarcinoma of the lung Phase III completed
dimesna San Antonio, TX www.bionumerik.com
tazemetostat Epizyme relapsed/refractory mesothelioma Phase II
(EZH2 enzyme inhibitor) Cambridge, MA www.epizyme.com
ORPHAN DRUG
NSCLC (+atezolizumab) Phase I
www.epizyme.com
Medicines in Development: Cancer ǀ 2018 109
Lung CancerProduct Name Sponsor Indication Development Phase
Tecentriq® Genentech ALK-positive NSCLC, NSCLC (adjuvant), Phase III
atezolizumab South San Francisco, CA 1L non-squamous NSCLC www.gene.com
(+nab-paclitaxel), 1L non-squamous
NSCLC (+bevacizumab +chemotherapy),
1L non-squamous NSCLC (+pemetrexed),
1L squamous NSCLC (+nab-paclitaxel),
1L squamous/non-squamous SCLC (+Dx),
1L extensive stage SCLC (+chemotherapy),
metastatic NSCLC Phase II
www.gene.com
NSCLC (+erlotinib +alectinib) Phase I
www.gene.com
tepotinib EMD Serono NSCLC Phase II
(c-Met kinase inhibitor) Rockland, MA www.emdserono.com
tesevatinib Kadmon Pharmaceuticals NSCLC Phase II
(protein tyrosine kinase inhibitor) New York, NY www.kadmon.com
TG-4010 Transgene NSCLC (+nivolumab) Phase II
(MVA-MUC1-IL2 cancer vaccine) Cambridge, MA www.transgene.fr
tislelizumab (BGB-A317) BeiGene USA NSCLC Phase III
(anti-PD-1 mAb) Cambridge, MA www.beigene.com
Celgene www.celgene.com
Summit, NJ
Medicines in Development: Cancer ǀ 2018 110
Lung CancerProduct Name Sponsor Indication Development Phase
trastuzumab deruxtecan (DS-8201) Daiichi Sankyo NSCLC Phase I
(anti-HER2 antibody-drug conjugate) Basking Ridge, NJ www.dsi.com
TRC-102 TRACON Pharmaceuticals mesothelioma Phase II
(methoxyamine hydrochloride) San Diego, CA www.traconpharma.com
NSCLC Phase I
www.traconpharma.com
TRC-105 TRACON Pharmaceuticals lung cancer Phase I
(carotuximab) San Diego, CA www.traconpharma.com
trilaciclib G1 Therapeutics 1L SCLC (combination therapy), Phase II
(CDK4/CDK6 inhibitor) Research Triangle Park, NC 2L/3L SCLC (combination therapy) www.g1therapeutics.com
U3-1402 Daiichi Sankyo NSCLC Phase I
(anti-HER3 antibody-drug conjugate) Basking Ridge, NJ www.dsi.com
Unituxin® United Therapeutics SCLC Phase II/III
dinutuximab Silver Spring, MD www.unither.con
veliparib AbbVie NSCLC Phase III
(PARP inhibitor) North Chicago, IL www.abbvie.com
ORPHAN DRUG
viagenpumatucel-L (HS-110) Heat Biologics NSCLC Phase II
(HSP cancer vaccine) Durham, NC www.heatbio.com
Medicines in Development: Cancer ǀ 2018 111
Lung CancerProduct Name Sponsor Indication Development Phase
VX15 Vaccinex NSCLC Phase I/II
(SEMA4D mAb) Rochester, NY www.vaccinex.com
XMT-1522 Mersana Therapeutics HER2-expressing NSCLC Phase I
(anti-HER2 antibody-drug conjugate) Cambridge, MA www.mersana.com
Zejula® TESARO advanced NSCLC (+/- anti-PD-1), Phase II
niraparib Waltham, MA squamous call carcinoma of the www.tesarobio.com
ORPHAN DRUG lung (+/- anti-PD-1)
LymphomaProduct Name Sponsor Indication Development Phase
abexinostat Xynomic Pharmaceuticals follicular lymphoma Phase III
(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com
peripheral T-cell lymphoma, diffuse Phase II
large B-cell lymphoma (DLBCL) www.xynomicpharma.com
(+ibrutinib)
ACTR087 Unum Therapeutics non-Hodgkin lymphoma (NHL) Phase I
(antibody-coupled T-cell receptor Cambridge, MA (+rituximab) www.unumrx.com
immunotherapy)
ACTR707 Unum Therapeutics NHL (+rituximab) Phase I
(ACTR immunotherpay) Cambridge, MA www.unumrx.com
Medicines in Development: Cancer ǀ 2018 112
LymphomaProduct Name Sponsor Indication Development Phase
Adcetris® Seattle Genetics 1L CD30-expressing mature T-cell Phase III
brentuximab vedotin Bothell, WA lymphoma, relapsed NHL (+nivolumab), www.seattlegenetics.com
ORPHAN DRUG Takeda Oncology mature T-cell lymphoma (Fast Track)
Northbrook, IL
1L Hodgkin lymphoma (60 years and Phase II
older), 2L Hodgkin lymphoma, www.seattlegenetics.com
relapsed NHL (+nivolumab)
ADCT-301 (camidanlumab tesirine) ADC Therapeutics Hodgkin lymphoma, NHL Phase I
(antibody-drug conjugate) Murray Hill, NJ www.adctherapeutics.com
ADCT-402 ADC Therapeutics B-cell NHL Phase I
(loncastuximab tesirine) Murray Hill, NJ www.adctherapeutics.com
AFM11 Affimed Therapeutics NHL Phase I
(CD19/CD3 antigen modulator) Heidelberg, Germany www.affimed.com
AFM13 Affimed Therapeutics CD30-positive lymphoma including Phase I/II
(CD30/CD16A antigen modulator) Heidelberg, Germany T-cell lymphoma www.affimed.com
ORPHAN DRUG
Hodgkin lymphoma Phase I
www.affimed.com
AG-270 Agios Pharmaceuticals lymphoma Phase I
(MAT2A inhibitor) Cambridge, MA www.agios.com
Medicines in Development: Cancer ǀ 2018 113
LymphomaProduct Name Sponsor Indication Development Phase
AGS67E Astellas lymphoid malignancies Phase I
(anti-CD37 antibody-drug conjugate) Northbrook, IL www.astellas.com
ALT-803 Altor BioScience relapsed/refractory indolent NHL Phase I/II
(IL-15 superagonist protein Miramar, FL www.altorbioscience.com
complex) NantKWest
Culver City, CA
ALX148 Alexo Therapeutics NHL Phase I
(CD47 checkpoint inhibitor) South San Francisco, CA www.alexotherapeutics.com
anti-CD19 CAR-T cell therapy Intrexon lymphoma Phase I
Germantown, MD www.intrexon.com
ZIOPHARM Oncology www.ziopharm.com
Boston, MA
APG-115 Ascentage Pharma lymphoma Phase I
(MDM2-P53 inhibitor) Rockville, MD en.ascentagepharma.com
apilimod dimesylate (LAM-002) LAM Therapeutics NHL Phase II
(PIKfyve kinase inhibitor) Guilford, CT www.lamtherapeutics.om
Aplidin PharmaMar relapsed/refractory angioimmuno- Phase II
plitidepsin Madrid, Spain blastic T-cell lymphoma www.pharmamar.com
Arzerra® Novartis Oncology refractory indolent NHL Phase III
ofatumumab East Hanover, NJ www.novartis.com
Medicines in Development: Cancer ǀ 2018 114
LymphomaProduct Name Sponsor Indication Development Phase
ASN002 Asana BioSciences relapsed/refractory lymphoma Phase I/II
(JAK/Syk inhibitor) Lawrenceville, NJ www.asanabiosciences.com
ASTX660 Astex Pharmaceuticals lymphoma Phase II
(IAP inhibitor) Pleasanton, CA www.astx.com
AvidinOx Alfasigma inoperable lymphomas Phase I
(177Lu-ST2210) Bologna, Italy www.alfasigma.com
axicabtagene ciloleucel Kite Pharma DLBCL, primary mediastinal B-cell Phase II
(CAR-T cell therapy) Santa Monica, CA lymphoma, transformed follicular www.kitepharma.com
ORPHAN DRUG lymphoma, indolent NHL
DLBCL (+PD-L1) Phase I
www.kitepharma.com
baltaleucel-T (CMD-003) Cell Medica extranodal natural killer T-cell Phase II
(T-lymphocyte cell therapy) Houston, TX lymphoma, DLBCL, Hodgkin lymphoma, www.cellmedica.com
ORPHAN DRUG post-transplant lymphoproliferative
disease (Fast Track)
BAY1862864 Bayer Pharmaceuticals NHL Phase I
(CD22-thorium conjugate) Whippany, NJ www.pharma.bayer.com
BAY1895344 Bayer Pharmaceuticals lymphoma Phase I
(ATR protein inhibitor) Whippany, NJ www.pharma.bayer.com
Medicines in Development: Cancer ǀ 2018 115
LymphomaProduct Name Sponsor Indication Development Phase
BCL201 Novartis Oncology follicular lymphoma (+idelalisib), Phase I
(Bcl-2 inhibitor) East Hanover, NJ mantle cell lymphoma (+idelalisib) www.novartis.com
Beleodaq® Spectrum Pharmaceuticals 1L peripheral T-cell lymphoma Phase I
belinostat Henderson, NV www.sppirx.com
Betalutin® Nordic Nanovector DLBCL Phase I
lilotomab satetraxetan Oslo, Norway www.nordicnanovector.com
ORPHAN DRUG
BI 836826 Boehringer Ingelheim Pharmaceuticals DLBCL Phase II
(anti-CD37 mAb) Ridgefield, CT www.boehringer-ingelheim.com
NHL Phase I
www.boehringer-ingelheim.com
Blincyto® Amgen relapsed/refractory DLBCL (adults) Phase II/III
blinatumomab Thousand Oaks, CA www.amgen.com
CA-170 Curis lymphoma Phase I
(PD-L1 checkpoint inhibitor) Lexington, MA www.curis.com
CA-4948 Curis MYD88-altered lymphoma Phase I
(IRAK4 kinase inhibitor) Lexington, MA www.curis.com
Medicines in Development: Cancer ǀ 2018 116
LymphomaProduct Name Sponsor Indication Development Phase
Calquence® Acerta Pharma 1L mantle cell lymphoma Phase III
acalabrutinib South San Francisco, CA www.astrazeneca.com
AstraZeneca
Wilmington, DE
CC-122 (avadomide) Celgene DLBCL, relapsed/refractory indolent Phase I
(pleiotropic pathway modulator) Summit, NJ lymphoma www.celgene.com
CC-486 Celgene DLBCL Phase I
(oral azacitidine) Summit, NJ www.celgene.com
CC-90002 Celgene NHL Phase I
(anti-CD47 antibody) Summit, NJ www.celgene.com
CC-90010 Celgene NHL Phase I
(BET inhibitor) Summit, NJ www.celgene.com
CC-90011 Celgene NHL Phase I
(LSD1 inhibitor) Summit, NJ www.celgene.com
CD11301 Galderma cutaneous T-cell lymphoma Phase II
(topical gel) Fort Worth, TX www.galdermausa.com
cirmtuzumab Oncternal Therapeutics mantel cell lymphoma, Phase I/II
(ROR1 antagonist) San Diego, CA small lymphocytic lymphoma www.oncternal.com
Medicines in Development: Cancer ǀ 2018 117
LymphomaProduct Name Sponsor Indication Development Phase
cobomarsen miRagen Therapeutics cutaneous T-cell lymphoma, DLBCL Phase I
(microRNA inhibitor) Boulder, CO www.miragen.com
ORPHAN DRUG
coltuximab ravtansine ImmunoGen DLBCL Phase II
(CD19-targeting antibody drug Waltham, MA www.immunogen.com
conjugate)
copanlisib Bayer Pharmaceuticals NHL Phase III
(PI3K inhibitor) Whippany, NJ www.pharma.bayer.com
ORPHAN DRUG
CPI-613 Rafael Pharmaceuticals high-grade B-cell lymphoma, Phase II
(altered energy metabolism- Newark, NJ relapsed/refractory Burkitt's www.rafaelpharma.com
derived medicine) lymphoma
ORPHAN DRUG
relapsed/refractory T-cell lymphoma Phase I
(combination therapy) www.rafaelpharma.com
CPI-1205 Constellation Pharmaceuticals B-cell lymphoma Phase I
(EZH2 enzyme inhibitor) Cambridge, MA www.constellationpharma.com
CX-072 CytomX Therapeutics lymphoma Phase I/II
(PD-L1 targeting probody) South San Francisco, CA www.cytomix.com
Medicines in Development: Cancer ǀ 2018 118
LymphomaProduct Name Sponsor Indication Development Phase
CYC065 Cyclacel Pharmaceuticals lymphoma Phase I
(CDK2/CDK9 inhibitor) Berkeley Heights, NJ www.cyclacel.com
CZ48 Cao Pharmaceuticals lymphoma Phase I
(DNA topoisomerase I inhibitor) Webster, TX www.caopharmaceuticals.com
NMT Pharmaceuticals
Webster, TX
darinaparsin (SP-02) Solasia Pharma peripheral T-cell lymphoma Phase II
ORPHAN DRUG Tokyo, Japan www.solasia.co.jp
DCDS0780A Roche/Genentech NHL Phase I
(anti-CD79b Thiomab™-drug conjugate) South San Francisco, CA www.roche.com
DEBIO 1562 (MGN529) Debiopharm B-cell NHL, DLBCL Phase II
(anti-CD37 antibody-drug conjugate) Lausanne, Switzerland www.immunogen.com
ORPHAN DRUG ImmunoGen
Waltham, MA
denintuzumab mafodotin Seattle Genetics DLBCL Phase II
(anti-CD19 antibody-drug conjugate) Bothell, WA www.seattlegenetics.com
DI-Leu16-IL2 Alopexx Oncology NHL Phase II
(immunocytokine fusion protein) Concord, MA www.alopexx.com
DTRMWXHS 12 Zhejiang DTRM Biopharma B-cell lymphoma Phase I
(BTK inhibitor) Hangzhou, China
Medicines in Development: Cancer ǀ 2018 119
LymphomaProduct Name Sponsor Indication Development Phase
duvelisib Verastem refractory indolent NHL, Phase II
(PI3K delta/PI3K gamma inhibitor) Needham, MA relapsed/refractory peripheral www.verastem.com
T-cell lymphoma
eFT508 eFFECTOR Therapeutics lymphoma Phase I/II
(MKNK1/MKNK2 protein inhibitor) San Diego, CA www.effector.com
enzastaurin (DB 102) Denovo Biopharma 1L DLBCL Phase III
(PKC-β and PI3K/AKT inhibitor) San Diego, CA www.denovobiopharma.com
ORPHAN DRUG
epacadostat Incyte lymphoma Phase I
(IDO1 inhibitor) Wilmington, DE www.incyte.com
fenretinide intravenous CerRx lymphoma (adults) Phase II
Lubbock, TX www.cerrx.com
FF-10502-01 FUJIFILM Pharmaceuticals U.S.A lymphoma Phase I
(DNA synthesis inhibitor) Valhalla, NJ www.fujifilmusa.com
fimepinostat (CUDC-907) Curis MYC-altered DLBCL Phase II
(HDAC/PI3K inhibitor) Lexington, MA www.curis.com
ORPHAN DRUG
Folotyn® Spectrum Pharmaceuticals 1L peripheral T-cell lymphoma Phase II
pralatrexate Henderson, NV www.sppirx.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 120
LymphomaProduct Name Sponsor Indication Development Phase
G100 Immune Design NHL (+pembrolizumab) Phase II
(TLR4 antagonist) Seattle, WA www.immunedesign.com
ORPHAN DRUG
GSK3326595 GlaxoSmithKline NHL Phase I
(PRMT5 inhibitor) Research Triangle Park, NC www.gsk.com
GWN323 Novartis Oncology lymphoma (+PDR001) Phase I
(anti-C+GITR mAb) East Hanover, NJ www.novartis.com
Hu5F9-G4 Forty Seven relapsed/refractory B-cell NHL Phase I/II
(CD47 antigen inhibitor mAb) Menlo Park, CA (+rituximab) www.fortyseveninc.com
iC9/CAR.19/IL15-transduced Bellicum Pharmaceuticals B-lymphoid malignancies, NHL Phase I/II
CB-NK cells Houston, TX www.bellicum.com
M.D. Anderson Cancer Center
Houston, TX
IGN002 ImmunGene relapsed/refractory NHL Phase I
(anti-CD20/interferon-alpha) Camarillo, CA
Imbruvica® Janssen Research & Development DLBCL, follicular lymphoma, Phase III
ibrutinib Raritan, NJ relapsed/refractory mature www.janssen.com
Pharmacyclics B-cell NHL (pediatric), treatment- www.pharmacyclics.com
Sunnyvale, CA naïve mantle cell lymphoma
(combination therapy), indolent NHL
(combination therapy)
Medicines in Development: Cancer ǀ 2018 121
LymphomaProduct Name Sponsor Indication Development Phase
Imfinzi® MedImmune DLBCL (monotherapy), Phase I
durvalumab Gaithersburg, MD DLBCL (+ tremelimumab or AZD9150) www.medimmune.com
INCB50465 Incyte DLBCL, follicular lymphoma, Phase II
(PI3K-delta inhibitor) Wilmington, DE mantle cell lymphoma, www.incyte.com
marginal zone lymphoma
IPH4102 Innate Pharma cutaneous T-cell lymphoma Phase I
(KIR3DL2 receptor antagonist) Marseille, France www.innate-pharma.com
ORPHAN DRUG
Istodax® Celgene 1L peripheral T-cell lymphoma Phase III
romidepsin Summit, NJ www.celgene.com
JCAR014 Juno Therapeutics relapsed/refractory B-cell NHL Phase I
(CD19 CAR-T cell therapy) Seattle, WA (+ durvalumab) www.junotherapeutics.com
KA2237 Karus Therapeutics B-cell lymphoma Phase I
(PI3K selective inhibitor) Oxfordshire, United Kingdom www.karustherapeutics.com
Keytruda® Merck relapsed/refractory primary application submitted
pembrolizumab Kenilworth, NJ mediastinal B-cell lymphoma www.merck.com
KPT-9274 Karyopharm Therapeutics NHL Phase I
(PAK4/NAMPT oral inhibitor) Newton, MA www.karyopharm.com
Medicines in Development: Cancer ǀ 2018 122
LymphomaProduct Name Sponsor Indication Development Phase
KTE-C19 CAR-T cell therapy Kite Pharma mantle cell lymphoma Phase II
(second generation anti-CD19) Santa Monica, CA www.kitepharma.com
ORPHAN DRUG
Kymriah™ Novartis Oncology relapsed/refractory DLBCL application submitted
tisagenlecleucel-T East Hanover, NJ www.novartis.com
(anti-CD19 CAT-T cell therapy)
relapsed/refractory DLBCL Phase III
(+pembrolizumab) www.novartis.com
relapsed/refractory DLBCL in 1st relapse, Phase II
relapsed/refractory follicular lymphoma www.novartis.com
LAM-002 LAM Therapeutics relapsed/refractory B-cell NHL Phase I
(PIKfyve kinase inhibitor) Guilford, CT www.lamtherapeutics.com
LAM-003 LAM Therapeutics NHL Phase I
(immunmodulator) Guilford, CT www.lamtherapeutics.com
lisocabtagene maraleucel (JCAR017) Juno Therapeutics relapsed/refractory aggressive Phase I
(CD19 CAR-T cell therapy) Seattle, WA large B-cell NHL www.junotherapeutics.com
ORPHAN DRUG
LY3039478 Eli Lilly T-cell ALL Phase I/II
(NOTCH inhibitor) Indianapolis, IN www.lilly.com
Medicines in Development: Cancer ǀ 2018 123
LymphomaProduct Name Sponsor Indication Development Phase
MAK683 Novartis Oncology DLBCL Phase I/II
(EED inhibitor) East Hanover, NJ www.novartis.com
MB-106 Mustang Bio relapsed/refractory B-cell NHL Phase I
(CAR-T cell therapy) New York, NY www.mustangbio.com
ME-401 MEI Pharma DLBCL (+rituximab), Phase I
(PI3K delta inhibitor) San Diego, CA follicular lymphoma, www.meipharma.com
indolent lymphoma (+rituximab)
mitoxantrone liposomal CSPC ZhongQi Pharmaceutical NHL Phase I/II
Shijiazhuang, China www.cspc.com.hk
MK-1454 Merck lymphoma Phase I
(STING agonist) Kenilworth, NJ www.merck.com
MK-2118 Merck lymphoma (+/-pembrolizumab) Phase I
Kenilworth, NJ www.merck.com
mogamulizumab Kyowa Hakko Kirin cutaneous T-cell lymphoma application submitted
(CCR4 receptor antagonist) Princeton, NJ www.kyowa-kirin.com
ORPHAN DRUG
adult T-cell leukemia/lymphoma Phase II
www.kyowa-kirin.com
Medicines in Development: Cancer ǀ 2018 124
LymphomaProduct Name Sponsor Indication Development Phase
MOR-208 (XmAb5574) MorphoSys
(B-cell inhibitor mAb) Planegg, Germany relapsed/refractory DLBCL (Fast Track) Phase II/III
ORPHAN DRUG www.morphosys.com
NHL, small lymphocytic lymphoma Phase II
www.morphosys.com
mRNA-2416 Moderna Therapeutics lymphoma Phase I
(OX40L protein modulator) Cambridge, MA www.modernatx.com
MT-3724 Molecular Templates relapsed B-cell NHL Phase I
(engineered toxin bodies [ETB] Austin, TX www.mtem.com
targeting CD20)
NAM-NK cells + IL-2 Gamida Cell NHL Phase I
(natural killer cells) Jerusalem, Israel www.gamida-cell.com
NBT-011 (ABI-011) NantBioScience lymphoma Phase I
(angiogenesis inhibitor) Culver City, CA www.nantworks.com
NIR178 Novartis Oncology NHL (+ PDR001) Phase II
(adenosine receptor antagonist) East Hanover, NJ www.novartis.com
NM-IL-12 Neumedicines cutaneous T-cell lymphoma Phase II
(recombinant interleukin-12) Pasadena, CA (radio-immunotherapy), www.neumedicines.com
DLBCL (chemo-immunotherapy)
Medicines in Development: Cancer ǀ 2018 125
LymphomaProduct Name Sponsor Indication Development Phase
ONC201 Oncoceutics lymphoma Phase I/II
(dopamine receptor D2/3 antagonist) Philadelphia, PA www.oncoceutics.com
Oncoquest™-L XEME Biopharma follicular lymphoma Phase I
non-Hodgkin lymphoma vaccine Lombard, IL www.xemebiopharma.com
Opdivo® Bristol-Myers Squibb CNS lymphoma, DLBCL Phase II
nivolumab Princeton, NJ primary testicular lymphoma, www.bms.com
follicular lymphoma
otlertuzumab Aptevo Therapeutics peripheral T-cell lymphoma Phase II
(CD37 protein inhibitor) Seattle, WA www.aptevotherapeutics.com
OXS-1550 GT Biopharma relapsed/refractory B-lineage Phase I/II
(bispecific scFv recombinant Washington, DC lymphoma www.gtbiopharma.com
fusion protein-drug conjugate)
Pixuvri® CTI BioPharma 2L aggressive NHL Phase III
pixantrone Seattle, WA (+rituximab) (Fast Track) www.ctibiopharma.com
polatuzumab vedotin Genentech 1L DLBCL Phase III
(anti-CD79b antibody-drug conjugate) South San Francisco, CA www.gene.com
relapsed/refractory DLBCL, Phase II
follicular lymphoma www.gene.com
Medicines in Development: Cancer ǀ 2018 126
LymphomaProduct Name Sponsor Indication Development Phase
REGN1979 Regeneron Pharmaceuticals NHL Phase I
(anti-CD20/CD3 bispecific mAb) Tarrytown, NY www.regeneron.com
remetinostat Medivir cutaneous T-cell lymphoma Phase II
(HDAC inhibitor) Huddinge, Sweden www.medivir.se
ORPHAN DRUG
Resimmune® Angimmune cutaneous T-cell lymphoma Phase I/II
anti-CD3 immunotoxin Rockville, MD www.angimmune.com
Revlimid® Celgene 1L DLBCL (ABC subtype), 1L follicular Phase III
lenalidomide Summit, NJ lymphoma, relapsed/refractory www.celgene.com
indolent lymphoma
RGX-104 Rgenix lymphoma Phase I
(LXR agonist) New York, NY www.rgenix.com
rituximab biosimilar Allergan NHL Phase III
(ABP 798) Parsippany, NJ www.amgen.com
Amgen
Thousand Oaks, CA
rituximab biosimilar Celltrion NHL application submitted
Incheon, South Korea www.celltrion.com
rituximab biosimilar Sandoz DLBCL, follicular lymphoma application submitted
(GP2013) Princeton, NJ www.sandoz.com
Medicines in Development: Cancer ǀ 2018 127
LymphomaProduct Name Sponsor Indication Development Phase
rituximab biosimilar Pfizer follicular lymphoma Phase III
(PF-052805860) New York, NY www.pfizer.com
rituximab biosimilar Archigen Biotech follicular lymphoma Phase III
(SAIT101) Cambridge, United Kingdom www.archigenbio.com
RO7082859 Roche/Genentech NHL Phase I
(T-cell bispecific antibody) South San Francisco, CA www.roche.com
RP4010 Rhizen Pharmaceuticals NHL Phase I
(ORAI1 protein inhibitor) La Chaux-de-Fonds, Switzerland www.rhizen.com
SEA-CD40 Seattle Genetics lymphoma (+/-checkpoint inhibitor) Phase I
(anti-CD40 mAb) Bothell, WA www.seattlegenetics.com
selinexor Karyopharm Therapeutics DLBCL Phase II
(nuclear export inhibitor) Newton, MA www.karyopharm.com
ORPHAN DRUG
SGN-CD19B Seattle Genetics relapsed/refractory aggressive Phase I
(anti-CD19 antibody-drug conjugate) Bothell, WA B-cell NHL www.seattlegenetics.com
SGX-301 ointment Soligenix cutaneous T-cell lymphoma (Fast Track) Phase III
(hypericin photodynamic therapy) Princeton, NJ www.soligenix.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 128
LymphomaProduct Name Sponsor Indication Development Phase
STRO-001 Sutro Biopharma B-cell lymphoma Phase I
(anti-CD74 antibody-drug conjugate) South San Francisco, CA www.sutrobio.com
Sym021 Symphogen lymphoma Phase I
(anti-PD-1 mAb) Somerville, NJ www.symphogen.com
TAK-659 Takeda Oncology DLBCL Phase II
(SYK/FLT3 inhibitor) Deerfield, IL www.takeda.com
tazemetostat Epizyme B-cell lymphoma, relapsed/refractory Phase I/II
(EZH2 enzyme inhibitor) Cambridge, MA DLBCL (+prednisolone) www.epizyme.com
1L DLBCL (+R-CHOP), Phase I
relapsed/refractory DLBCL www.epizyme.com
(+atezolizumab)
Tecentriq® Genentech relapsed/refractory DLBCL Phase I
atezolizumab South San Francisco, CA (+obinutuzumab/tazemetostat) www.gene.com
follicular lymphoma
(+obinutuzumab/tazemetostat)
tenalisib (RP6530) Rhizen Pharmaceuticals cutaneous T-cell lymphoma (Fast Track), Phase I
(PI3K-delta/gamma inhibitor) La Chaux-de-Fonds, Switzerland peripheral T-cell lymphoma (Fast Track) www.rhizen.com
ORPHAN DRUG
tipifarnib Kura Oncology peripheral T-cell lymphoma Phase II
(farnesyltranstransferase inhibitor) San Diego, CA www.kuraoncology.com
Medicines in Development: Cancer ǀ 2018 129
LymphomaProduct Name Sponsor Indication Development Phase
Toca 511 + Toca Fc Tocagen lymphoma Phase I
(vocimagene amiretrorepvec- San Diego, CA www.tocagen.com
flucytosine gene therapy)
TPA Rich Pharmaceuticals Hodgkin lymphoma Phase II
(tetradecanoylphorbol acetate) Beverly Hills, CA www.richpharmaceuticals.com
tractinostat Viracta Therapeutics EBV-positive lymphoma Phase I/II
(HDAC inhibitor) Cardiff, CA (+valganciclovir) www.viracta.com
TTI-621 Trillium Therapeutics mycosis fungoides Phase I
(CD47 inhibitors/SIRPA stimulant) Mississauga, Canada (cutaneous T-cell lymphoma) www.trilliumtherapeutics.com
ORPHAN DRUG
ublituximab + umbralisib TG Therapeutics NHL Phase II/III
(anti-CD20 mAb/PI3K inhibitor) New York, NY www.tgtherapeutics.com
umbralisib (TGR-1202) TG Therapeutics non-follicular NHL Phase II
(PI3K inhibitor) New York, NY www.tgtherapeutics.com
urelumab Bristol-Myers Squibb B-cell NHL Phase I/II
(anti-CD137 mAb) Princeton, NJ www.bms.com
Venclexta™ AbbVie DLBCL (+rituximab), follicular lymphoma, Phase II
venetoclax North Chicago, IL relapsed/refractory follicular lymphoma www.abbvie.com
ORPHAN DRUG Genentech (+rituximab) www.gene.com
South San Francisco, CA
Medicines in Development: Cancer ǀ 2018 130
LymphomaProduct Name Sponsor Indication Development Phase
zanubrutinib (BGB-3111) BeiGene 1L small lymphocytic lymphoma Phase III
(BTK inhibitor) Cambridge, MA www.beigene.com
relapsed/refractory follicular lymphoma Phase II
(+ obinutuzumab) www.beigene.com
B-cell lymphoid malignancies Phase I
www.beigene.com
Multiple MyelomaProduct Name Sponsor Indication Development Phase
ABC294640 (Yeliva®) RedHill Biopharma multiple myeloma Phase I/II
(sphingosine kinase-2 inhibitor) Raleigh, NC www.redhillbio.com
ACTR-BCMA Unum Therapeutics multiple myeloma Phase I
(ACTR087 + SEA-BCMA) Cambridge, MA www.unumrx.com
Seattle Genetics www.seattlegenetics.com
Bothell, WA
ALT-803 Altor BioScience relapsed/refractory multiple myeloma Phase I
(IL-15 superagonist protein Miramar, FL www.altorbioscience.com
complex)
AMG 176 Amgen relapsed/refractory multiple myeloma Phase I
(MCL1 protein inhibitor) Thousand Oaks, CA www.amgen.com
Medicines in Development: Cancer ǀ 2018 131
Multiple MyelomaProduct Name Sponsor Indication Development Phase
AMG 224 Amgen relapsed/refractory multiple myeloma Phase I
(antibody-drug conjugate) Thousand Oaks, CA www.amgen.com
AMG 420 Amgen multiple myeloma Phase I
(anti-BCMA x anti-CD3 Thousand Oaks, CA www.amgen.com
bispecific T-cell engager)
AMG 701 Amgen multiple myeloma Phase I
(anti-BCMA x anti-CD3 Thousand Oaks, CA www.amgen.com
bispecific T-cell engager)
anti-CD38 CAR-T cell therapy Sorrento Therapeutics relapsed/refractory multiple myeloma Phase I
San Diego, CA www.sorrentotherapeutics.com
BAY2402234 Bayer Pharmaceuticals myeloid leukemia Phase I
(DHODH inhibitor) Whippany, NJ www.pharma.bayer.com
bb2121 bluebird bio relapsed/refractory multiple myeloma Phase II
(anti-BCMA CAR-T cell therapy) Cambridge, MA www.bluebirdbio.com
ORPHAN DRUG Celgene www.celgene.com
Summit, NJ
bb21217 bluebird bio multiple myeloma Phase I
(anti-BCMA CAR-T cell therapy) Cambridge, MA www.bluebirdbio.com
ORPHAN DRUG Celgene www.celgene.com
Summit, NJ
Medicines in Development: Cancer ǀ 2018 132
Multiple MyelomaProduct Name Sponsor Indication Development Phase
BFCR4350A (RG6160) Genentech relapsed/refractory multiple myeloma Phase I
South San Francisco, CA www.gene.com
BION-1301 Aduro BioTech multiple myeloma Phase I/II
(anti-APRIL mAb) Berkeley, CA www.aduro.com
BL-8040 BioLineRx multiple myeloma (combination therapy) Phase III
(CXCR4 chemokine receptor antagonist) Modi’in, Israel www.biolinerx.com
bortezomib intravenous Allergan multiple myeloma application submitted
Parsippany, NJ www.allergan.com
CB-5083 Cleave Biosciences multiple myeloma Phase I
(p97 inhibitor) Burlingame, CA www.cleavebio.com
ORPHAN DRUG
CC-122 (avadomide) Celgene multiple myeloma Phase I
(pleiotropic pathway modulator) Summit, NJ www.celgene.com
CC-220 Celgene relapsed/refractory multiple myeloma Phase I
(CRBN protein inhibitor) Summit, NJ www.celgene.com
CC-92480 Celgene relapsed/refractory multiple myeloma Phase I
(CELMoD) Summit, NJ www.celgene.com
Medicines in Development: Cancer ǀ 2018 133
Multiple MyelomaProduct Name Sponsor Indication Development Phase
CC-93269 Celgene relapsed/refractory multiple myeloma Phase I
(T-cell bispecific antibody) Summit, NJ www.celgene.com
CDX-301 Celldex Therapeutics multiple myeloma Phase I
(recombinant Flt-3 ligand) Hampton, NJ www.celldex.com
citarinostat (ACY-241) Celgene relapsed/refractory multiple myeloma Phase I
(HDAC6 protein inhibitor) Summit, NJ www.celgene.com
CJM112 Novartis Oncology multiple myeloma Phase I
(IL17A protein inhibitor) East Hanover, NJ www.novartis.com
CLR-131 Cellectar Biosciences multiple myeloma Phase II
(phospholipid-drug conjugate) Madison, WI www.cellectar.com
ORPHAN DRUG
CWP 232291 JW Pharmaceutical relapsed/refractory multiple myeloma Phase I
(Wnt signalling pathway inhibitor) Seoul, South Korea www.jw-pharma.co.kr
Medicines in Development: Cancer ǀ 2018 134
Multiple MyelomaProduct Name Sponsor Indication Development Phase
Darzalex® Janssen Research & Development 1L multiple myeloma application submitted
daratumumab Raritan, NJ (transplant ineligible) www.janssen.com
1st-line multiple myeloma (transplant Phase III
eligible), relapsed/refractory multiple www.janssen.com
myeloma, smoldering multiple
myeloma
multiple myeloma Phase III
(subcutaneous formulation) www.janssen.com
Empliciti® AbbVie 1L multiple myeloma Phase III
elotuzumab North Chicago, IL www.abbvie.com
Bristol-Myers Squibb www.bms.com
Princeton, NJ
galinpepimut-S Sellas Life Sciences multiple myeloma Phase II
(anti-WT1 peptide cancer vaccine) New York, NY www.sellaslifesciences.com
GBR 1342 Glenmark Pharmaceuticals multiple myeloma Phase I
(CD38/CD3 bispecific antibody) Mumbai, India www.glenmarkpharma.com
GMI-1271 GlycoMimetics multiple myeloma Phase I
(uproleselan sodium) Rockville, MD www.tgtherapeutics.com
GSK2857916 GlaxoSmithKline multiple myeloma Phase II
(antibody-drug conjugate) Research Triangle Park, NC www.gsk.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 135
Multiple MyelomaProduct Name Sponsor Indication Development Phase
GSK3377794 GlaxoSmithKline multiple myeloma Phase II
(NY-ESO-autologous engineered Research Triangle Park, NC www.gsk.com
T-cell receptor therapy)
indatuximab ravtansine (BT-062) Biotest multiple myeloma Phase II
(anti-CD138/DM4 immunoconjugte) Dreieich, Germany www.biotest.com
ORPHAN DRUG ImmunoGen www.immunogen.com
Waltham, MA
isatuximab Sanofi relapsing/refractory multiple myeloma, Phase III
(anti-CD38 mAb) Bridgewater, NJ 1L newly-diagnosed multiple myeloma www.sanofi.com
ORPHAN DRUG
newly-diagnosed multiple myeloma Phase I
(+ combination therapy), relapsed/ www.sanofi.com
refractory multiple myeloma
(+ cemiplimab)
JCARH125 Juno Therapeutics multiple myeloma Phase I
(anti-BCMA CAR-T cell therapy) Seattle, WA www.junotherapeutics.com
JNJ-63723283 Janssen Research & Development multiple myeloma (+daratumumab) Phase I
(anti-PD-1 mAb) Raritan, NJ www.janssen.com
JNJ-64007957 Janssen Research & Development relapsed/refractory multiple myeloma Phase I
(BCMA CD3 DuoBody® antibody) Raritan, NJ www.janssen.com
Medicines in Development: Cancer ǀ 2018 136
Multiple MyelomaProduct Name Sponsor Indication Development Phase
JNJ-64407564 Janssen Research & Development relapsed/refractory multiple myeloma Phase I
(bispecific antibody) Raritan, NJ www.janssen.com
KITE-585 Kite Pharma multiple myeloma Phase I
(anti-BCMA CAR-T cell therapy) Santa Monica, CA www.kitepharma.com
LCL161 Novartis Oncology relapsed/refractory multiple myeloma Phase II
(apoptosis protein inhibitor) East Hanover, NJ www.novartis.com
mivebresib (ABBV-075) AbbVie multiple myeloma Phase I
(BET inhibitor) North Chicago, IL www.abbvie.com
MTV273 Novartis Oncology multiple myeloma Phase I
(BCMA-targeted CAR-T cell therapy) East Hanover, NJ www.novartis.com
NAM-NK cells + IL-2 Gamida Cell multiple myeloma Phase I
(nicotinamide expanded Jerusalem, Israel www.gamida-cell.com
(haploidentical or mismatched
related donor natural killer cells)
Ninlaro® Takeda Oncology 1L multiple myeloma, Phase III
ixazomib Deerfield, IL multiple myeloma (maintenance), www.takeda.com
relapsed/refractory multiple myeloma
(doublet regimen)
ONC201 Oncoceutics multiple myeloma Phase II
(dopamine receptor D2/3 antagonist) Philadelphia, PA www.oncoceutics.com
Medicines in Development: Cancer ǀ 2018 137
Multiple MyelomaProduct Name Sponsor Indication Development Phase
Opdivo® Bristol-Myers Squibb multiple myeloma Phase III
nivolumab Princeton, NJ www.bms.com
oprozomib Amgen relapsed/refractory multiple myeloma Phase I
(oral proteasome inhibitor) Thousand Oaks, CA www.amgen.com
ORPHAN DRUG
P-BCMA-101 Poseida Therapeutics multiple myeloma Phase I
(CAR-T cell therapy) San Diego, CA www.poseida.com
PF-06863135 Pfizer multiple myeloma Phase I
(bispecific protein) New York, NY www.pfizer.com
PNK-007 Celularity multiple myeloma Phase I
(natural killer cell therapy) Warren, NJ www.celularity.com
PT-112 Phosplatin Therapeutics relapsed/refractory multiple myeloma Phase I
phosphaplatin New York, NY www.phosplatin.com
ORPHAN DRUG
PVX-410 OncoPep smoldering multiple myeloma, Phase I
(multi-peptide cancer vaccine) Boston, MA smoldering multiple myeloma www.oncopep.com
ORPHAN DRUG (+durvalumab)
Medicines in Development: Cancer ǀ 2018 138
Multiple MyelomaProduct Name Sponsor Indication Development Phase
selinexor Karyopharm Therapeutics multiple myeloma (+bortezomib) Phase III
(nuclear export inhibitor) Newton, MA (Fast Track) www.karyopharm.com
ORPHAN DRUG
multiple myeloma (+dexamethasone) Phase II
(Fast Track), multiple myeloma www.karyopharm.com
(+backbone therapies) (Fast Track)
SGN-CD48A Seattle Genetics relapsed/refractory multiple myeloma Phase I
(antiCD48 antibody-drug conjugate) Bothell, WA www.seattlegenetics.com
SGN-CD352A Seattle Genetics relapsed/refractory multiple myeloma Phase I
(anti-CD351 antibody-drug conjugate) Bothell, WA www.seattlegenetics.com
SL-401 Stemline Therapeutics relapsed/refractory multiple myeloma Phase I/II
(recombinant fusion protein) New York, NY (+pomalidomide) www.stemline.com
STRO-001 Sutro Biopharma multiple myeloma Phase I
(anti-CD74 antibody-drug conjugate) South San Francisco, CA www.sutrobio.com
Sylvant® Janssen Research & Development high-risk smoldering multiple myeloma Phase II
siltuximab Raritan, NJ www.janssen.com
TAK-573 Takeda Oncology refractory multiple myeloma Phase I
(anti-CD38 attenukine) Deerfield, IL www.takeda.com
Tecentriq® Genentech multiple myeloma Phase I
atezolizumab South San Francisco, CA (+/-lenalidomide +/-daratumumab) www.gene.com
Medicines in Development: Cancer ǀ 2018 139
Multiple MyelomaProduct Name Sponsor Indication Development Phase
Venclexta™ AbbVie multiple myeloma Phase III
venetoclax North Chicago, IL www.abbvie.com
ORPHAN DRUG Genentech www.gene.com
South San Francisco, CA
Ygalo® Oncopeptides multiple myeloma Phase II
peptidase-potentiated alkylator Stockholm, Sweden www.oncopeptides.com
ORPHAN DRUG
Ovarian CancerProduct Name Sponsor Indication Development Phase
AL3818 Advenchen Laboratories ovarian cancer Phase I/II
(tyrosine kinase inhibitor) Moorpark, CA www.advenchen.com
amcasertib (BBI503) Boston Biomedical ovarian cancer Phase II
(cancer cel [stemness] inhibitor) Cambridge, MA www.bostonbiomedical.com
anetumab ravtansine Bayer Pharmaceuticals recurrent mesothelin-expressing Phase I
(antibody-drug conjugate) Whippany, NJ platinum-resistant ovarian cancer www.pharma.bayer.com
APR-246 Aprea Therapeutics platinum-sensitive high grade serous Phase II
(tumor suppressor protein Boston, MA ovarian cancer www.aprea.com
p53 stimulant)
platinum-resistant high grade serous Phase I
ovarian cancer www.aprea.com
Medicines in Development: Cancer ǀ 2018 140
Ovarian CancerProduct Name Sponsor Indication Development Phase
Avastin® Genentech relapsed platinum-sensitive application submitted
bevacizumab South San Francisco, CA ovarian cancer www.gene.com
ORPHAN DRUG
AZD1775 (adavosertib) AstraZeneca ovarian cancer (+chemotherapy) Phase II
(WEE1 kinase inhibitor) Wilmington, DE www.astrazeneca.com
Bavencio® EMD Serono 1L ovarian, platinum-resistant/refractory Phase III
avelumab Rockland, MA ovarian cancer www.emdserono.com
(anti-PD-L1 inhibitor) Pfizer www.pfizer.com
New York, NY
camptothecin (CRLX101) BlueLink Pharmaceuticals ovarian cancer (Fast Track) Phase II
ORPHAN DRUG Ames, IA
cantrixil Kazia Therapeutics ovarian cancer Phase I
(SMETI inhibitor) Sydney, Australia www.kaziatherapeutics.com
ORPHAN DRUG
CDX-014 Celldex Therapeutics ovarian cancer Phase I
(TIM-1 antibody-drug conjugate) Hampton, NJ www.celldex.com
CDX-1401 Celldex Therapeutics ovarian cancer Phase II
(NY-ESO-1) Hampton, NJ (combination therapy) www.celldex.com
COTI-2 Cotinga Pharmaceuticals ovarian cancer Phase I
(p53 gene modulator) London, Canada www.cotingapharma.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 141
Ovarian CancerProduct Name Sponsor Indication Development Phase
DCVax®-L Northwest Biotherapeutics ovarian cancer Phase I completed
cancer vaccine Bethesda, MD www.nwbio.com
defactinib Verastem ovarian cancer (+avelumab) Phase II
(FAK inhibitor) Needham, MA www.verastem.com
ORPHAN DRUG
DKN-01 Leap Therapeutics endometroid ovarian cancer Phase II
(anti-DKK1 mAb) Cambridge, MA (combination therapy) www.leaptx.com
DPX-Survivac Immunovaccine advanced ovarian cancer (Fast Track) Phase I
(cancer vaccine) Halifax, Canada www.imvaccine.com
ORPHAN DRUG
entinostat Syndax Pharmaceuticals ovarian cancer (+avelumab) Phase II
(HDAC inhibitor) Waltham, MA www.syndax.com
EP-100 Esperance Pharmaceuticals ovarian cancer Phase II
(precision targeted membrane- Houston, TX www.esperancepharma.com
disrupting peptide)
EP-201 EpiThany ovarian cancer Phase I
(IGFBP-2 vaccine) Seattle, WA www.epithany.com
epacadostat Incyte ovarian cancer Phase I
(IDO1 inhibitor) Wilmington, DE www.incyte.com
Medicines in Development: Cancer ǀ 2018 142
Ovarian CancerProduct Name Sponsor Indication Development Phase
farletuzumab (MORAb-003) Eisai platinum-sensitive ovarian cancer Phase II
(IgG1 mAb) Woodcliff Lake, NJ www.eisai.com
ORPHAN DRUG
FATE-NK100 Fate Therapeutics ovarian cancer Phase I
(natural killer cell stimulant) La Jolla, CA www.fatetherapeutics.com
GALE-301 Sellas Life Sciences ovarian cancer Phase I/II
(E39 peptide vaccine) New York, NY www.sellalifesciences.com
ORPHAN DRUG
GALE-302 Sellas Life Sciences ovarian cancer Phase I/II
(E39 peptide vaccine) New York, NY www.sellalifesciences.com
ORPHAN DRUG
galinpepimut-S Sellas Life Sciences ovarian cancer (+nivolumab) Phase I/II
(anti-WT1 peptide cancer vaccine) New York, NY www.sellaslifesciences.com
GEN-1 Celsion ovarian cancer Phase I/II
(IL-2 plasmid vector nanoparticles) Lawrenceville, NJ www.celsion.com
ORPHAN DRUG
GSK3377794 GlaxoSmithKline ovarian cancer Phase II
(NY-ESO-autologous engineered Research Triangle Park, NC www.gsk.com
T-cell receptor therapy)
IMT-1012 Immunotope ovarian cancer Phase I completed
(immunotherapeutic vaccine) Doylestown, PA www.immunotope.com
Medicines in Development: Cancer ǀ 2018 143
Ovarian CancerProduct Name Sponsor Indication Development Phase
karenitecin BioNumerik Pharmaceuticals advanced ovarian cancer Phase III completed
(DNA topoisomerase inhibitor) San Antonio, TX www.bionumerick.com
Kevetrin™ Innovation Pharmaceuticals ovarian cancer Phase II
p53 protein stimulant Beverly, MA www.ipharminc.com
ORPHAN DRUG
Keytruda® Merck ovarian cancer Phase II
pembrolizumab Kenilworth, NJ www.merck.com
Lynparza® AstraZeneca 1L BRCA-mutated ovarian cancer, Phase III
olaparib Wilmington, DE 2L or greater BRCA-mutation www.astrazeneca.com
platinum-sensitive recurrent
ovarian cancer (maintenance),
gBRCA-mutated platinum-sensitive
recurrent ovarian cancer
recurrent platinum-resistant ovarian Phase II
cancer (+cediranib) www.astrazeneca.com
masitinib AB Science relapsed metastatic ovarian cancer Phase III
(protein tyrosine kinase inhibitor) Paris, France www.ab-science.com
mirvetuximab soravtansine ImmunoGen FOLR1-positive ovarian cancer Phase III
(folate receptor 1 antagonist) Waltham, MA www.immunogen.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 144
Ovarian CancerProduct Name Sponsor Indication Development Phase
NanoPac® NanOlogy ovarian cancer Phase II
paclitaxel nanoformulation Fort Worth, TX www.nanology.us
ORPHAN DRUG
navicixizumab OncoMed Pharmaceuticals ovarian cancer Phase I
(anti-DLL4/VEGF bispecific mAb) Redwood City, CA www.oncomed.com
NUC-1031 NuCana platinum-resistant ovarian cancer Phase II
(DNA synthesis inhibitor) Newton, MA www.nucana.com
ONCOS-102 Targovax platinum-resistant ovarian cancer Phase I/II
(oncolytic virus therapy) Oslo, Norway www.targovax.com
ORPHAN DRUG
Opdivo® Bristol-Myers Squibb ovarian cancer Phase I/II
nivolumab Princeton, NJ www.bms.com
Opdivo® + Yervoy® Bristol-Myers Squibb ovarian cancer Phase I/II
nivolumab + ipilimumab Princeton, NJ www.bms.com
oregovomab OncoQuest ovarian cancer (+chemotherapy) Phase II
(MUC16 protein mAb) Edmonton, Canada www.oncoquestinc.com
ORPHAN DRUG
ovarian cancer (+poly ICLC) Phase I
www.oncoquestinc.com
Medicines in Development: Cancer ǀ 2018 145
Ovarian CancerProduct Name Sponsor Indication Development Phase
ovapuldencel-T AiVita Biomedical advanced ovarian cancer Phase II
(dendritic cell cancer vaccine) Irvine, CA www.aivitabiomedical.com
prexasertib Eli Lilly platinum-resistant or refractory Phase II
(CHK1 inhibitor) Indianapolis, IN ovarian cancer www.lilly.com
Prolanta™ Oncolix ovarian cancer Phase I
prolactin receptor antagonist Houston, TX www.oncolixbio.com
ORPHAN DRUG
PTC596 PTC Therapeutics ovarian cancer Phase I
(tumor stem cell targeting) South Plainfield, NJ www.ptcbio.com
PTX-200 Prescient Therapeutics relapsed/refractory ovarian cancer Phase I
(Akt inhibitor) South Melbourne, Australia www.ptxtherapeutics.com
RG7882 Genentech ovarian cancer Phase I
(anti-MUC16 THIOMAB drug conjugate) South San Francisco, CA www.gene.com
RRx-001 EpicentRx ovarian epithelial cancer Phase II
(free radical stimulant) La Jolla, CA www.epicentrx.com
Rubraca® Clovis Oncology ovarian cancer (+nivolumab) Phase III
rucaparib Boulder, CO www.clovisoncology.com
(PARP inhibitor)
Medicines in Development: Cancer ǀ 2018 146
Ovarian CancerProduct Name Sponsor Indication Development Phase
sapacitabine Cyclacel Pharmaceuticals ovarian cancer (+seliciclib) Phase II
(nucleoside analogue) Berkeley Heights, NJ www.cyclacel.com
SC-003 AbbVie ovarian cancer Phase I
(antibody-drug conjugate) North Chicago, IL www.abbvie.com
SPL-108 Splash Pharmaceuticals ovarian epithelial cancer Phase II
(anti-CD44) San Diego, CA www.splashpharma.com
platinum-resistant ovarian cancer Phase I
www.splashpharma.com
taladegib Ignyta ovarian cancer (combination therapy) Phase I
(hedgehog pathway/SMO inhibitor) San Diego, CA www.ignyta.com
Tecentriq® Genentech 1L ovarian cancer Phase III
atezolizumab South San Francisco, CA (+bevacizumab +chemotherapy) www.gene.com
ovarian cancer (+rucaparib) Phase I
www.gene.com
TPIV200 TapImmune platinum-sensitive ovarian cancer Phase II
(folate receptor-alpha vaccine) Jacksonville, FL (Fast Track) www.tapimmune.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 147
Ovarian CancerProduct Name Sponsor Indication Development Phase
varlilumab Celldex Therapeutics ovarian cancer (+nivolumab) Phase II
(anti-CD28 mAb) Hampton, NJ www.celldex.com
VB-111 VBL Therapeutics recurrent platinum-resistant Phase III
(ofranergene obadenovec) Modi'in, Israel ovarian cancer www.vblrx.com
ORPHAN DRUG
veliparib AbbVie ovarian cancer Phase III
(PARP inhibitor) North Chicago, IL www.abbvie.com
Vigil™ Gradalis ovarian cancer Phase II
autologous tumor cell vaccine Carrolton, TX www.gradalisinc.com
Yondelis® Janssen Research & Development relapsed ovarian cancer Phase III
trabectedin Raritan, NJ www.janssen.com
ORPHAN DRUG
Zejula® TESARO advanced ovarian cancer following Phase III
niraparib Waltham, MA response on 1L platinum-based www.tesarobio.com
ORPHAN DRUG chemotherapy
1L ovarian cancer (+bevacizumab), Phase II
ovarian cancer (+bevacizumab), www.tesarobio.com
ovarian cancer (+pembrolizumab),
ovarian cancer (monotherapy)
Medicines in Development: Cancer ǀ 2018 148
Ovarian CancerProduct Name Sponsor Indication Development Phase
ZW25 Zymeworks HER2-expressing ovarian cancer Phase I
(bispecific antibody) Vancouver, Canada www.zymeworks.com
ORPHAN DRUG
Pancreatic CancerProduct Name Sponsor Indication Development Phase
AbGn-107 AbGenomics pancreatic cancer Phase I
(antibody-drug conjugate) Los Altos, CA www.abgenomics.com
Abraxane® Celgene pancreatic cancer (adjuvant therapy) Phase III
paclitaxel protein-bound particles Summit, NJ www.celgene.com
for injectable suspension
(albumin-bound)
aglatimagene besadenovec Advantagene pancreatic cancer Phase I/II
(gene therapy) Auburndale, MA www.advantagene.com
AM0010 ARMO Biosciences pancreatic ductal adenocarcinoma Phase III
(PEG-IL-10) Redwood City, CA (Fast Track) www.armobio.com
ORPHAN DRUG
antroquinonol Golden Biotechnology pancreatic cancer Phase I/II
(rare medicinal fungus) New Taipei City, Taiwan www.goldenbiotech.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 149
Pancreatic CancerProduct Name Sponsor Indication Development Phase
AR20.5 OncoQuest pancreatic cancer Phase I/II
(anti-MUC1 mAb) Edmonton, Canada www.oncoquestinc.com
ARQ 761 ArQule pancreatic cancer Phase II
(NQO1 inhibitor) Burlington, MA www.arqule.com
BL-8040 BioLineRx metastatic pancreatic cancer Phase II
(CXCR4 chemokine receptor antagonist) Modi’in, Israel (+pembrolizumab) www.biolinerx.com
BPM31510 Berg advanced pancreatic cancer Phase II
(cancer cell metabolism restorer) Framingham, MA (+/- gemcitabine) www.berghealth.com
ORPHAN DRUG
BPX-601 Bellicum Pharmaceuticals non-resectable pancreatic cancer Phase I
(anti-PSCA CAR-T cell therapy) Houston, TX www.bellicum.com
BVD-523 BioMed Valley Discoveries metastatic pancreatic cancer Phase I
(ERK inhibitor) Kanas City, MO (+nab-paclitaxel +gemcitabine) www.biomed-valley.com
cabiralizumab Five Prime Therapeutics pancreatic cancer (+nivolumab) Phase II
(anti-CSF1R) South San Francisco, CA www.fiveprime.com
Bristol-Myers Squibb
Princeton, NJ
Cabometyx™ Exelixis pancreatic neuroendocrine tumors Phase II
cabozantinib South San Francisco, CA www.exelixis.com
Medicines in Development: Cancer ǀ 2018 150
Pancreatic CancerProduct Name Sponsor Indication Development Phase
CCX872 ChemoCentryx advanced pancreatic cancer Phase II
(CCR2 receptor antagonist) Mountain View, CA www.chemocentryx.com
CPI-613 Rafael Pharmaceuticals 1L metastatic pancreatic cancer Phase III
(altered energy metabolism- Newark, NJ (+modified FOLFIRINOX) www.rafaelpharma.com
derived medicine)
ORPHAN DRUG
1L locally advanced pancreatic cancer Phase II
(+modified FOLFIRINOX) www.rafaelpharma.com
1L advanced or metastatic Phase I
pancreatic cancer www.rafaelpharma.com
(+gemcitabine +nab-paclitaxel)
defactinib Verastem pancreatic cancer (+pembrolizumab), Phase I
(FAK inhibitor) Needham, MA relapsed pancreatic cancer www.verastem.com
ORPHAN DRUG (+pembrolizumab +gemcitabine)
encapsulated live cells PharmaCyte Biotech pancreatic cancer Phase II
converting ifosfamide Laguna Hills, CA www.pharmacyte.com
(genetically engineered live human cells)
ORPHAN DRUG
ensituximab Precision Biologics advanced pancreatic cancer Phase II
(neoplasm antigen inhibitor) Rockville, MD www.precision-biologics.com
ORPHAN DRUG
evofosfamide Molecular Templates pancreatic cancer (+ipilimumab) Phase I
ORPHAN DRUG Austin, TX www.mtem.com
Medicines in Development: Cancer ǀ 2018 151
Pancreatic CancerProduct Name Sponsor Indication Development Phase
ficlatuzumab AVEO Oncology pancreatic cancer Phase II
(HGF/c-Met inhibitor) Cambridge, MA www.aveooncology.com
galunisertib Eli Lilly metastatic pancreatic cancer Phase I
(TGF-beta 1 inhibitor) Indianapolis, IN (+ durvalumab) www.lilly.com
GC4419 Galera Therapeutics pancreatic cancer Phase I/II
(superoxide dismutase modulator) Malvern, PA (+ stereotactic body radiation therapy) www.galeratx.com
glufosfamide Eleison Pharmaceuticals 2L metastatic pancreatic cancer Phase III
(DNA synthesis inhibitor) Princeton, NJ (Fast Track) www.eleision-pharma.com
ORHAN DRUG
Imbruvica® Janssen Research & Development pancreatic cancer Phase III
ibrutinib Raritan, NJ www.janssen.com
Pharmacyclics www.pharmacyclics.com
Sunnyvale, CA
Imfinzi® MedImmune pancreatic ductal adenocarcinoma Phase II
durvalumab Gaithersburg, MD (+AZD5069) www.medimmune.com
1L pancreatic ductal adenocarcinoma Phase I
(+tremelimumab +chemotherapy) www.medimmune.com
indoximod NewLink Genetics metastatic pancreatic cancer Phase II
(IDO inhibitor) Ames, IA (combination therapy) www.newlinkgenetics.com
Medicines in Development: Cancer ǀ 2018 152
Pancreatic CancerProduct Name Sponsor Indication Development Phase
IRX4204 Io Therapeutics pancreatic cancer Phase I
(RXR agonist) Santa Ana, CA www.io-therapeutics.com
istiratumab (MM-141) Merrimack Pharmaceuticals pancreatic cancer Phase II
(PI3K/AKT/mTOR inhibitor) Cambridge, MA www.merrimack.com
ORPHAN DRUG
LMB-100 Selecta Biosciences pancreatic cancer Phase I/II
(recombinant immunotoxin) Watertown, MA www.selectabio.com
LOAd703 Lokon Pharma pancreatic cancer Phase I/II
(oncolytic virus therapy) Uppsala, Sweden www.lokonpharma.com
ORPHAN DRUG
Lynparza® AstraZeneca pancreatic cancer Phase III
olaparib Wilmington, DE www.astrazeneca.com
Merck pancreatic cancer Phase III
Kenilworth, NJ (combination therapy) www.merck.com
masitinib AB Science pancreatic cancer Phase III
(protein tyrosine kinase inhibitor) Paris, France www.ab-science.com
ORPHAN DRUG
MENK (IRT-101) Cytocom advanced pancreatic cancer Phase II
(opioid growth factor) Orlando, FL www.cytocom.com
Medicines in Development: Cancer ǀ 2018 153
Pancreatic CancerProduct Name Sponsor Indication Development Phase
MVT-1075 MabVax Therapeutics pancreatic cancer Phase I
(177Lu mAB 5B1/radio- San Diego, CA www.mabvax.com
imunotherapy)
MVT-5873 MabVax Therapeutics pancreatic cancer, metastatic prostate Phase I
(5B1 mAb) San Diego, CA (+chemotherapy) www.mabvax.com
NanoPac® NanOlogy pancreatic cancer Phase II
paclitaxel nanoformulation Fort Worth, TX www.nanology.us
NANT pancreatic cancer vaccine NantKwest pancreatic cancer (combination therapy) Phase I/II
(activated natural killer cells - Culver City, CA www.nantkwest.com
haNK for infusion)
napabucasin Boston Biomedical pancreatic cancer Phase III
(STAT3 inhibitor) Cambridge, MA (+nab-paclitaxel +gemcitabine) www.bostonbiomedical.com
ORPHAN DRUG
pancreatic cancer (+chemotherapy) Phase I
www.bostonbiomedical.com
Onivyde® Ipsen Biopharmaceuticals 1L pancreatic ductal adenocarcinoma Phase II
irinotecan liposome injection Basking Ridge, NJ www.ipsen.com
Opdivo® Bristol-Myers Squibb pancreatic cancer Phase I/II
nivolumab Princeton, NJ www.bms.com
Medicines in Development: Cancer ǀ 2018 154
Pancreatic CancerProduct Name Sponsor Indication Development Phase
OT-101 Autotelic pancreatic cancer Phase II/III
(TGF-beta antisense) Costa Mesa, CA www.oncotelic.com
ORPHAN DRUG Oncotelic
Agoura Hills, CA
pamrevlumab FibroGen pancreatic cancer (Fast Track) Phase II
(anti-CTGF antibody) San Francisco, CA www.fibrogen.com
ORPHAN DRUG
PBI-05204 Phoenix Biotechnology pancreatic cancer Phase II
(Nerium oleander herbal extract) San Antonio, TX www.phoenixbiotechnology.com
PEGPH20 Halozyme Therapeutics pancreatic cancer (Fast Track) Phase III
(pegylated recombinant San Diego, CA (+nab-paclitaxel +gemcitabine) www.halozyme.com
human hyalurinodase)
ORPHAN DRUGpancreatic cancer (+atezolizumab) Phase I
www.halozyme.com
polyclonal antibody stimulator Cancer Advances pancreatic cancer Phase III
(fusion peptide) Durham, NC www.canceradvancesinc.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 155
Pancreatic CancerProduct Name Sponsor Indication Development Phase
Reolysin® Oncolytics Biotech
pelareorep Calgary, Canada pancreatic cancer (+gemcitabine), Phase II
ORPHAN DRUG metastatic pancreatic cancer www.oncolyticsbiotech.com
(+paclitaxel +carboplatin)
advanced or metastatic pancreatic Phase I
cancer (+pembrolizumab) www.oncolyticsbiotech.com
RX-3117 Rexahn Pharmaceuticals 3L metastatic pancreatic cancer, Phase II
(DNA and RNA synthesis inhibitor) Rockville, MD 1L metastatic pancreatic cancer www.rexahn.com
ORPHAN DRUG (+palbociclib)
sapacitabine Cyclacel Pharmaceuticals pancreatic cancer (+seliciclib) Phase II
(nucleoside analogue) Berkeley Heights, NJ www.cyclacel.com
SBP-101 Sun BioPharma pancreatic ductal adenocarcinoma Phase I
(polyamine analogue) Waconia, MN www.sunbiopharma.com
ORPHAN DRUG
SEL-403 Selecta Biosciences pancreatic cancer Phase I
(recombinant immunotoxin + Watertown, MA www.selectabio.com
SVP-rapamycin)
SGT-53 SynerGene Therapeutics metastatic pancreatic cancer Phase II
(gene therapy) Rockville, MD (+gemcitabine +nab-paclitaxel)
Medicines in Development: Cancer ǀ 2018 156
Pancreatic CancerProduct Name Sponsor Indication Development Phase
siG12D-LODER Silenseed pancreatic cancer Phase II
(antisense K-ras RNA gene therapy) Modi’in, Israel www.silenseed.com
SM-88 Tyme Technologies metastatic pancreatic cancer Phase II
(free radical stimulant) New York, NY www.tymeinc.com
Tecentriq® Genentech pancreatic cancer Phase I
atezolizumab South San Francisco, CA (+bevacizumab +chemotherapy) www.gene.com
Prostate CancerProduct Name Sponsor Indication Development Phase
ABBV-744 AbbVie advanced prostate cancer Phase I
(BRD2/3/4 inhibitor) North Chicago, IL www.abbvie.com
ADXS-PSA Advaxis metastatic castration-resistant Phase I/II
(cancer immunotherapy vaccine) Princeton, NJ prostate cancer, metastatic www.advaxis.com
castration-resistant prostate cancer
(+pembrolizumab)
AE37 (HER2.neu) Antigen Express metastatic prostate cancer Phase I
(Li-key hybrid cancer vaccine) Wellesley, MA www.antigenexpress.com
Medicines in Development: Cancer ǀ 2018 157
Prostate CancerProduct Name Sponsor Indication Development Phase
aglatimagene besadenovec Advantagene intermediate and high-risk prostate Phase III
(gene therapy) Auburndale, MA cancer (Fast Track) www.advantagene.com
prostate cancer (proactive surveillance) Phase II/III
www.advantagene.com
APVO414 Aptevo Therapeutics metastatic castration-resistant Phase I
(bispecific immunotherapeutic) Seattle, WA prostate cancer www.aptevotherapeutics.com
cabazitaxel injection Accord Healthcare hormone-refractory metastatic application submitted
Durham, NC prostate cancer (+prednisone) www.accordhealthcare.us
cabazitaxel injection Allergan hormone-refractory metastatic application submitted
Parsippany, NJ prostate cancer www.allergan.com
CORT125281 Corcept Therapeutics metastatic castration-resistant Phase I
(glucocorticoid receptor antagonist) Menlo Park, CA prostate cancer www.corcept.com
CPI-1205 Constellation Pharmaceuticals metastatic castration-resistant Phase I/II
(EZH2 enzyme inhibitor) Cambridge, MA prostate cancer www.constellationpharma.com
darolutamide Bayer Pharmaceuticals non-metastatic castration-resistant Phase III
(androgen receptor antagonist) Whippany, NJ prostate cancer, metastatic www.pharma.bayer.com
hormone-sensitive prostate cancer
Medicines in Development: Cancer ǀ 2018 158
Prostate CancerProduct Name Sponsor Indication Development Phase
DCVax®-Prostate Northwest Biotherapeutics prostate cancer Phase II completed
cancer vaccine Bethesda, MD www.nwbio.com
Dicopp™ Cantex Pharmaceuticals metastatic castration-resistant Phase I
copper gluconate/disulfiram Weston, FL prostate cancer www.cantex.com
DPV-001 UbiVac prostate cancer Phase I
(autophagosome-enriched vaccine) Portland, OR www.ubivac.com
eltanexor oral (KPT-8602) Karyopharm Therapeutics metastatic castration-resistant Phase I/II
(nuclear export inhibitor) Newton, MA prostate cancer www.karyopharm.com
enoblituzumab MacroGenics prostate cancer (neoadjuvant) Phase I
(anti-B7-H3 IgG1/κ mAb) Rockville, MD www.macrogenics.com
Erleada® Janssen Research & Development metastatic hormone-sensitive prostate Phase III
apalutamide Raritan, NJ cancer, localized prostate cancer www.janssen.com
evofosfamide Molecular Templates prostate cancer (+ipilimumab) Phase I
Austin, TX www.mtem.com
fexapotide Nymox Pharmaceutical low-risk localized (T1c) prostate Phase II completed
Hasbrouck Heights, NJ cancer www.nymox.com
FP-001 Foresee Pharmaceuticals prostate cancer Phase III
(leuprorelin depot) Newark, DE www.foreseepharma.com
Medicines in Development: Cancer ǀ 2018 159
Prostate CancerProduct Name Sponsor Indication Development Phase
GSK2636771 GlaxoSmithKline castration-resistant prostate cancer Phase I
(PI3K beta inhibitor) Research Triangle Park, NC www.gsk.com
GT0918 Suzhou Kintor Pharmaceuticals metastatic castration-resistant Phase I/II
(proxalutamide) Suzhou, China prostate cancer
indoximod NewLink Genetics metastatic castration-resistant Phase II
(IDO inhibitor) Ames, IA prostate cancer (+sipuleucel-T) www.newlinkgenetics.com
INO-5150 Inovio Pharmaceuticals prostate cancer Phase I
(PSA/PMSA DNA cancer vaccine) Plymouth Meeting, PA www.inovio.com
IONIS-AR-2.5RX (AZD5312) Ionis Pharmaceuticals prostate cancer Phase II
(olignucleotide antisense drug) Carlsbad, CA www.ionispharma.com
IRX4204 Io Therapeutics prostate cancer Phase II
(RXR agonist) Santa Ana, CA www.io-therapeutics.com
JNJ 63723283 Janssen Research & Development castration-resistant prostate cancer Phase I/II
(anti-PD-1 mAb) Raritan, NJ (+niraparib) www.janssen.com
JNJ-64041809 (ADU-741) Aduro Biotech castration-resistant prostate cancer Phase I
(live attenuated double-deleted Berkeley, CA www.aduro.com
Listeria immunotherapy) Janssen Research & Development www.janssen.com
Raritan, NJ
Medicines in Development: Cancer ǀ 2018 160
Prostate CancerProduct Name Sponsor Indication Development Phase
Keytruda® Merck prostate cancer Phase II
pembrolizumab Kenilworth, NJ www.merck.com
LY01005 Luye Pharma prostate cancer Phase I
(goserelin extended release) Shanghai, China www.luye-pharm.com
LY3023414 Eli Lilly prostate cancer (combination therapy) Phase II
(PI3K/mTOR inhibitor) Indianapolis, IN www.lilly.com
Lynparza® AstraZeneca prostate cancer Phase III
olaparib Wilmington, DE www.astrazeneca.com
Merck prostate cancer (combination therapy) Phase III
Kenilworth, NJ www.merck.com
MEDI3726 MedImmune prostate cancer Phase I
(antibody-drug conjugate) Gaithersburg, MD www.medimmune.com
MIP-1095 I-131 Progenics Pharmaceuticals prostate cancer Phase I
(small molecule thernostic) New York, NY www.progenics.com
MVI-118 Madison Vaccines metastatic prostate cancer Phase I
(plasmid DNA cancer vaccine) Madison, WI www.madisonvaccinesinc.com
Medicines in Development: Cancer ǀ 2018 161
Prostate CancerProduct Name Sponsor Indication Development Phase
MVI-816 Madison Vaccines biochemically recurrent prostate Phase II
(plasmid DNA cancer vaccine) Madison, WI cancer www.madisonvaccinesinc.com
metastatic castration-resistant Phase I
prostate cancer (+pembrolizumab) www.madisonvaccinesinc.com
NanoPac® NanOlogy prostate cancer Phase II
paclitaxel nanoformulation Fort Worth, TX www.nanology.us
NBTXR3 Nanobiotix prostate cancer Phase I/II
(radio-enhancer nanoparticle) Paris, France www.nanobiotix.com
Opdivo® Bristol-Myers Squibb prostate cancer Phase II
nivolumab Princeton, NJ www.bms.com
padeliporfin di-potassium Steba Biotech localized prostate cancer Phase II
(vascular dusrupting agent) Luxembourg City, Luxembourg www.stebabiotech.com
PAN-301-1 Panacea Pharmaceuticals prostate cancer Phase I
(HAAH-directed nanoparticle vaccine) Gaithersburg, MD www.panaceapharma.com
PCM-075 TrovaGene castration-resistant prostate cancer Phase II
(PLK1 inhibitor) San Diego, CA www.trovagene.com
PCUR-101 Pellficure Pharmaceuticals metastatic castration-resistant Phase I
San Diego, CA prostate cancer
Medicines in Development: Cancer ǀ 2018 162
Prostate CancerProduct Name Sponsor Indication Development Phase
PF-06753512 Pfizer prostate cancer Phase I
(vaccine-based immunotherapy) New York, NY (combination therapy) www.pfizer.com
ProscaVax OncBioMune Pharmaceuticals prostate cancer Phase I
PSA/IL-12/GM-CSF vaccine Baton Rouge, LA www.oncobiomune.com
Prostvac Bavarian Nordic prostate cancer Phase II
rilimogene galvacirepvec- Morrisville, NC (combination therapy) www.bavarian-nordic.com
rilimogene glafolivec Bristol-Myers Squibb www.bms.com
Princeton, NJ
Provenge® Dendreon metastatic castrate-resistant Phase II completed
sipuleucel-T Seal Beach, CA prostate cancer (combination www.dendreon.com
therapy)
PSA/IL-2/GM-CSF vaccine OncBioMune Pharmaceuticals prostate cancer Phase I
Baton Rouge, LA www.oncbiomune.com
PSMA-617 Endocyte metastatic castration-resistant Phase II
(radioligand therapy) West Lafayette, IN prostate cancer www.endocyte.com
Radio Medix
Houston, TX
REIC gene therapy Momotaro-Gene localized prostate cancer Phase I/II
Okayama, Japan www.mt-gene.com
relugolix Myovant Sciences advanced prostate cancer Phase III
(GnRH receptor antagonist) Brisbane, CA www.myovant.com
Medicines in Development: Cancer ǀ 2018 163
Prostate CancerProduct Name Sponsor Indication Development Phase
Rubraca® Clovis Oncology metastatic castration-resistant Phase III
rucaparib Boulder, CO prostate cancer (combination therapy) www.clovisoncology.com
(PARP inhibitor)
metastatic castration-resistant Phase II
prostate cancer www.clovisoncology.com
sacituzumab govitecan Immunomedics metastatic prostate cancer Phase II
(anti-TROP-2-SN-38 ADC) Morris Plains, NJ www.immunomedics.com
seviteronel (INO-464) Innocrin Pharmaceuticals castration-resistant prostate cancer Phase II
(CYP17 lyase inhibitor) Durham, NC (Fast Track) www.innocrinpharma.com
SM-88 Tyme Technologies recurrent non-metastatic Phase II
(free radical stimulant) New York, NY prostate cancer www.tymeinc.com
stapuldencel-T (DCVAC/Pca) SOTIO metastatic castration-resistant Phase III
(autologous immunotherapy) Prague, Czech Republic prostate cancer www.sotio.com
talazoparib Pfizer 1L metastatic castration-resistant Phase III
(PARP inhibitor) New York, NY prostate cancer www.pfizer.com
2L metastatic castration-resistant Phase II
prostate cancer www.pfizer.com
TAS3681 Taiho Oncology metastatic castration-resistant Phase I
(androgen receptor antagonist) Princeton, NJ prostate cancer www.taihooncology.com
Medicines in Development: Cancer ǀ 2018 164
Prostate CancerProduct Name Sponsor Indication Development Phase
Tecentriq® Genentech castration-resistant prostate cancer Phase III
atezolizumab South San Francisco, CA (+enzalutamide) www.gene.com
metastatic castration-resistant Phase I
prostate cancer (+radium 223) www.gene.com
topsalysin (PRX302) Sophiris Bio localized prostate cancer Phase II
(cell membrane modulator) La Jolla, CA www.sophirisbio.com
TRC-253 Janssen Research & Development prostate cancer Phase I
(androgen receptor antagonist) Raritan, NJ www.traconpharma.com
TRACON Pharmaceuticals
San Diego, CA
Xtandi® Astellas non-metastatic castration-resistant application submitted
enzalutamide Northbrook, IL prostate cancer www.astellas.com
Pfizer www.pfizer.com
New York, NY
metastatic hormone-sensitive Phase III
prostate cancer, non-metastatic www.astellas.com
high-risk hormone-sensitive prostate www.pfizer.com
cancer
Yonsa® Churchill Pharmaceuticals metastatic castration-resistant application submitted
abiraterone acetate King of Prussia, PA prostate cancer www.churchhillpharma.com
(submicron particles)
Medicines in Development: Cancer ǀ 2018 165
Prostate CancerProduct Name Sponsor Indication Development Phase
ZEN-3694 Zenith Epigenetics metastatic castration-resistant Phase I/II
(BET inhibitor) San Francisco, CA prostate cancer www.zenithepigenetics.com
Zytiga® Janssen Research & Development castration-resistant metastatic Phase III
abiraterone acetate Raritan, NJ prostate cancer (chemotherapy naïve) www.janssen.com
(+apalutamide)
SarcomaProduct Name Sponsor Indication Development Phase
AL3818 Advenchen Laboratories metastatic or advanced alveolar Phase III
(tyrosine kinase inhibitor) Moorpark, CA soft part sarcoma, leiomyosarcoma, www.advenchen.com
synovial sarcoma
aldoxorubicin CytRx 2L soft tissue sarcoma Phase III
ORPHAN DRUG Los Angeles, CA www.cytrx.com
NantKwest
Culver City, CA
soft tissue sarcoma (+ifosfamide) Phase I/II
www.cytrx.com
AMG 337 NantPharma advanced or metastatic clear cell sarcoma Phase II
(c-Met inhibitor) Culver City, CA www.nantpharma.com
AU101 Aurora BioPharma osteosarcoma Phase I/II
(HER2-CD28 CAR-T cell therapy) Cambridge, MA www.aurora-biopharma.com
Medicines in Development: Cancer ǀ 2018 166
SarcomaProduct Name Sponsor Indication Development Phase
Cabometyx™ Exelixis relapsed osteosarcoma, Ewing sarcoma, Phase II
cabozantinib South San Francisco, CA soft tissue sarcoma www.exelixis.com
CBT-1 CBA Pharma sarcoma Phase I
(tetrandrine) Lexington, KY www.cbapharma.com
CMB305 Immune Design soft tissue sarcoma Phase II
(antigen-specific prime boost) Seattle, WA www.immunedesign.com
ORPHAN DRUG
Gilotrif® Boehringer Ingelheim Pharmaceuticals rhabdomyosarcoma Phase I/II
afatinib Ridgefield, CT www.boehringer-ingelheim.com
GSK3377794 GlaxoSmithKline mixed round cell liposarcoma, Phase II
(NY-ESO-autologous engineered Research Triangle Park, NC synovial sarcoma www.gsk.com
T-cell receptor therapy)
ORPHAN DRUG
HDM201 Novartis Oncology liposarcoma (+LEE011) Phase I
(p53-HDM2 inhibitor) East Hanover, NJ www.novartis.com
inhaled lipid-complexed cisplatin Eleison Pharmaceuticals recurrent pulmonary osteosarcoma Phase II
Princeton, NJ www.eleison-pharma.com
Lartruvo® Eli Lilly soft tissue sarcoma (+pembrolizumab) Phase I
olaratumab Indianapolis, IN www.lilly.com
Medicines in Development: Cancer ǀ 2018 167
SarcomaProduct Name Sponsor Indication Development Phase
MNPR-201 Monopar Therapeutics soft tissue sarcoma Phase II
(GPX-150; 5-imino- Wilmette, IL www.monopartx.com
13-deoxydoxorubicin)
ORPHAN DRUG
naxitamab Y-mAbs Therapeutics osteosarcoma (pediatric) Phase II
(anti-GD2 3F8 mAb) New York, NY www.ymabs.com
ORPHAN DRUG
NC-6300 NanoCarrier soft tissue sarcoma Phase I
(epirubicin micelle) Chiba, Japan www.nanocarrier.co.jp
ORPHAN DRUG
NKTR-214 Nektar Therapeutics sarcoma (+nivolumab) Phase II
(CD122-biased immune- San Francisco, CA www.nektar.com
stimulatory cytokine)
selinexor Karyopharm Therapeutics liposarcoma Phase III
(nuclear export inhibitor) Newton, MA www.karyopharm.com
ORPHAN DRUG
tazemetostat Epizyme synovial sarcoma Phase I
(EZH2 enzyme inhibitor) Cambridge, MA www.epizyme.com
ORPHAN DRUG
TK216 Oncternal Therapeutics Ewing sarcoma (Fast Track) Phase I
(c-ets inhibitor) San Diego, CA www.oncternal.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 168
SarcomaProduct Name Sponsor Indication Development Phase
TRC-105 TRACON Pharmaceuticals angiosarcoma Phase III
(carotuximab) San Diego, CA www.traconpharma.com
ORPHAN DRUG
Vigil™ Gradalis Ewing's sarcoma Phase III
autologous tumor cell vaccine Carrolton, TX www.gradalisinc.com
Zejula® TESARO Ewing's sarcoma (+chemotherapy) Phase I
niraparib Waltham, MA www.tesarobio.com
Skin CancerProduct Name Sponsor Indication Development Phase
APX005M Apexigen malignant melanoma (+nivolumab) Phase I/II
(CD40 agonistic antibody) San Carlos, CA www.apexigen.com
Bavencio® EMD Serono melanoma (+4-1BB) Phase II
avelumab Rockland, MA www.emdserono.com
(anti-PD-L1 inhibitor) Pfizer www.pfizer.com
New York, NY
binimetinib Array BioPharma BRAF-mutant unresectable or application submitted
(MEK inhibitor) Boulder, CO metastatic melanoma (+encorafenib) www.arraybiopharma.com
BMS-986205 Bristol-Myers Squibb advanced melanoma (+nivolumab) Phase III
(IDO1 inhibitor) Princeton, NJ www.bms.com
Medicines in Development: Cancer ǀ 2018 169
Skin CancerProduct Name Sponsor Indication Development Phase
Cavatak® Viralytics advanced melanoma (+pembrolizumab), Phase I
coxsackievirus Sydney, Australia advanced melanoma (+ipilimumab) www.viralytics.com
ORPHAN DRUG
cemiplimab Regeneron Pharmaceuticals basal cell carcinoma Phase II
(anti-PD-1 mAb) Tarrytown, NY www.sanofi.com
Sanofi
Bridgewater, NJ
CLL442 Novartis Oncology cutaneous squamous cell Phase I/II
East Hanover, NJ carcinoma in situ www.novartis.com
CMP-001 Checkmate Pharmaceuticals malignant melanoma (+pembrolizumab) Phase I
(TLR9 agonist cancer vaccine) Cambridge, MA www.checkmatepharma.com
Cotellic® Genentech 1L BRAF-mutant metastatic melanoma Phase III
cobimetinib South San Francisco, CA (+ atezolizumab + vemurafenib), www.gene.com
ORPHAN DRUG 1L BRAF wild type metastatic melanoma
(+atezolizumab)
2L BRAF wild type metastatic Phase I
melanoma (+atezolizumab), www.gene.com
melanoma (+atezolizumab +vemurafenib)
daromun (darleukin/fibromun) Philogen malignant melanoma Phase III
(L19IL2-L19TNF) Sovicille, Italy www.philogen.com
(recombinant fusion proteins)
Medicines in Development: Cancer ǀ 2018 170
Skin CancerProduct Name Sponsor Indication Development Phase
encorafenib Array BioPharma malignant melanoma application submitted
(BRAF inhibitor) Boulder, CO www.arraybiopharma.com
entinostat Syndax Pharmaceuticals melanoma (+pembrolizumab) Phase II
(HDAC inhibitor) Waltham, MA www.syndax.com
epacadostat Incyte melanoma Phase I
(IDO1 inhibitor) Wilmington, DE www.incyte.com
evofosfamide Molecular Templates melanoma (+ipilimumab) Phase I
Austin, TX www.mtem.com
GR-MD-02 Galectin Therapeutics melanoma (+ipilimumab), Phase I
(galectin 3 inhibitor) Norcross, GA melanoma (+pembrolizumab) www.galectintherapeutics.com
GRN-1201 BrightPath Biotherapeutics melanoma Phase I
(cancer peptide vaccine) Tokyo, Japan www.brightpathbio.com
GSK3377794 GlaxoSmithKline melanoma Phase II
(NY-ESO-autologous engineered Research Triangle Park, NC www.gsk.com
T-cell receptor therapy)
HBI-8000 HUYA Bioscience melanoma Phase I/II
(HDAC inhibitor) San Diego, CA www.huyabio.com
Medicines in Development: Cancer ǀ 2018 171
Skin CancerProduct Name Sponsor Indication Development Phase
HF10 Takara Bio USA malignant melanoma Phase II
(canerpaturev, oncolytic virus therapy) Mountain View, CA www.takara-bio.com
Imfinzi® MedImmune melanoma (+dabrafenib +trametinib) Phase II
durvalumab Gaithersburg, MD www.medimmune.com
Imlygic® Amgen mid- to late-stage metastatic Phase III
talimogene laherparepvec Thousand Oaks, CA melanoma (+pembrolizumab) www.amgen.com
(oncolytic virus therapy)
Imprime PGG® Biothera Pharmaceuticals metastatic melanoma (+pembrolizumab) Phase I/II
immunostimulant PGG glucan Eagan, MN www.biothera.com
indoximod NewLink Genetics advanced melanoma Phase II/III
(IDO inhibitor) Ames, IA (+PD-1 inhibitors) www.newlinkgenetics.com
ORPHAN DRUG
IPI-549 Infinity Pharmaceuticals melanoma (+nivolumab) Phase I
(PI3K-gamma inhibitor) Cambridge, MA www.infi.com
LAG525 Novartis Oncology melanoma (+PDR001) Phase I/II
(anti-LAG3 mAb) East Hanover, NJ www.novartis.com
LN-144 Iovance Biotherapeutics malignant melanoma (Fast Track) Phase II
(tumor-infiltrating lymphocyte) San Carlos, CA www.iovance.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 172
Skin CancerProduct Name Sponsor Indication Development Phase
MAGE-A10 TCR Adaptimmune melanoma Phase I/II
(T-cell receptor therapy) Philadelphia, PA www.adaptimmune.com
MORAb-004 Eisai melanoma Phase II
(ontuxizumab) Woodcliff Lake, NJ www.eisai.com
NanoPac® NanOlogy cutaneous metastases Phase II
paclitaxel nanoformulation Fort Worth, TX www.nanology.us
NANT merkel cell cancer vaccine NantKwest merkel cell carcinoma Phase II
(activated natural killer cells - Culver City, CA www.nantkwest.com
haNK for infusion)
ORPHAN DRUG
NEO-PV-01 Neon Therapeutics melanoma Phase I
(personal neoantigen vaccine) Cambridge, MA www.neontherapeutics.com
ONCOS-102 Targovax advanced or unresectable melanoma Phase I
(oncolytic virus therapy) Oslo, Norway progressing after PD1 blockade www.targovax.com
OT-101 Autotelic melanoma Phase II/III
(TGF-beta antisense) Costa Mesa, CA www.oncotelic.com
Oncotelic
Agoura Hills, CA
patidegib PellePharm basal cell carcinoma Phase II
(hedgehog signaling inhibitor) San Francisco, CA www.pellepharm.com
Medicines in Development: Cancer ǀ 2018 173
Skin CancerProduct Name Sponsor Indication Development Phase
PV-10 Provectus Biopharmaceuticals locally advanced cutaneous melanoma Phase III
(rose bengal sodium) Knoxville, TN www.provectusbio.com
ORPHAN DRUG
metastatic melanoma (+pembrolizumab) Phase I
www.provectusbio.com
REM-001 (rostaporfin) Adgero Biopharmaceuticals locally advanced basal cell carcinoma Phase I
(photosensitizer) Princeton, NJ www.adgerobiopharm.com
Resimmune® Angimmune malignant melanoma Phase I/II
anti-CD3 immunotoxin Rockville, MD www.angimmune.com
SD-101 Dynavax Technologies malignant melanoma (+pembrolizumab) Phase I/II
(TLR9 agonist) Berkeley, CA www.dynavax.com
seviprotimut-L (POL-103A) Polynoma malignant melanoma Phase III
ORPHAN DRUG San Diego, CA www.polynoma.com
spartalizumab (PDR001) Novartis Oncology malignant melanoma Phase III
(anti-PD-1 mAb) East Hanover, NJ (+dabrafenib +trametinib) www.novartis.com
malignant melanoma Phase II
www.novartis.com
SUBA-itraconazole HedgePath Pharmaceuticals basal cell carcinoma nevus syndrome Phase II
(hedgehog pathway inhibitor) Tampa, FL www.hedgepathpharma.com
Medicines in Development: Cancer ǀ 2018 174
Skin CancerProduct Name Sponsor Indication Development Phase
tavokinogene telsaplasmid Oncosec Medical metastatic melanoma (Fast Track), Phase II
(interleukin-12 gene therapy) San Diego, CA advanced metastatic melanoma www.oncosec.com
ORPHAN DRUG (+pembrolizumab)
telomelysin Oncolys Biopharma metastatic melanoma Phase II
(oncolytic virus immunotherapy) Tokyo, Japan www.oncolys.com
tilsotolimod (IMO-2125) Idera Pharmaceuticals metastatic melanoma (+ipilimumab) Phase III
(TLR9 agonist) Cambridge, MA (Fast Track) www.iderapharma.com
ORPHAN DRUG
metastatic melanoma Phase I/II
(+ipilimumab or pembrolizumab) www.iderapharma.com
TLPLDC Elios Therapeutics metastatic melanoma Phase II
(tumor lysate particle-loaded Austin, TX www.eliostherapeutics.com
dendritic cell vaccine)
X4P-001-IO X4 Pharmaceuticals melanoma Phase I/II
(CXCR4 inhibitor) Cambridge, MA www.4xpharma.com
Solid TumorsProduct Name Sponsor Indication Development Phase
ABBV-085 AbbVie solid tumors Phase I
(antibody-drug conjugate) North Chicago, IL www.abbvie.com
Medicines in Development: Cancer ǀ 2018 175
Solid TumorsProduct Name Sponsor Indication Development Phase
ABBV-176 AbbVie solid tumors Phase I
(antibody-drug conjugate) North Chicago, IL www.abbvie.com
ABBV-181 AbbVie solid tumors Phase I
(immunotherapeutic) North Chicago, IL www.abbvie.com
ABBV-321 AbbVie advanced solid tumors Phase I
North Chicago, IL www.abbvie.com
ABBV-368 AbbVie solid tumors Phase I
(intravenous immunotherapeutic) North Chicago, IL www.abbvie.com
ABBV-428 AbbVie solid tumors Phase I
(anti-CD40 bispecific antibody) North Chicago, IL www.abbvie.com
ABBV-621 AbbVie solid tumors Phase I
(TRAIL receptor agonist) North Chicago, IL www.abbvie.com
ABBV-927 AbbVie solid tumors Phase I
(immunotherapeutic) North Chicago, IL www.abbvie.com
abexinostat Xynomic Pharmaceuticals solid tumors (+pembrolizumab) Phase II
(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com
ABT-165 AbbVie late-stage solid tumors Phase I
(VEGF and DLL4 inhibitor) North Chicago, IL www.abbvie.com
Medicines in Development: Cancer ǀ 2018 176
Solid TumorsProduct Name Sponsor Indication Development Phase
Actimmune® Horizon Pharma solid tumors (+nivolumab) Phase I
interferon gamma-1b Lake Forest, IL www.horizonpharma.com
ADU-S100 (MIW815) Aduro Biotech solid tumors (+ipilimumab), Phase I
(STING pathway activator) Berkeley, CA solid tumors (monotherapy) www.aduro.com
Novartis Oncology
East Hanover, NJ
ADXS-HER2 Advaxis HER2-expressing solid tumors Phase I/II
(cancer immunotherapy) Princeton, NJ www.advaxis.com
AEB1102 Aeglea Biotherapeutics advanced solid tumors Phase I(pegzilarginase) Austin, TX www.aegleabio.com
AG-270 Agios Pharmaceuticals solid tumors Phase I
(MAT2A inhibitor) Cambridge, MA www.agios.com
AGEN1884 Agenus advanced solid tumors Phase I
(CTLA-4 antagonist) Lexington, MA www.agenus.com
AGEN2034 Agenus solid tumors Phase I/II
(PD-1 protein inhibitor) Lexington, MA www.agenus.com
ALKS 4230 Alkermes solid tumors Phase I
(fusion protein and immuno- Waltham, MA www.alkermes.com
therapeutic based on IL-2)
Medicines in Development: Cancer ǀ 2018 177
Solid TumorsProduct Name Sponsor Indication Development Phase
ALRN-6924 Aileron Therapeutics solid tumors Phase I
(MDM2/MDMX antagonist) Cambridge, MA www.aileronrx.com
ALT-803 Altor BioScience advanced solid tumors Phase I
(IL-15 superagonist protein Miramar, FL www.altorbioscience.com
complex)
ALX148 Alexo Therapeutics solid tumors Phase I
(CD47 checkpoint inhibitor) South San Francisco, CA www.alexotherapeutics.com
AM0010 ARMO Biosciences solid tumors Phase I(PEG-IL-10) Redwood City, CA www.armobio.com
amcasertib (BBI503) Boston Biomedical solid tumors (monotherapy) Phase II
(cancer cell [stemness] inhibitor) Cambridge, MA www.bostonbiomedical.com
solid tumors (combination therapy) Phase I
www.bostonbiomedical.com
AMG 337 NantPharma advanced or metastatic solid tumors Phase II
(c-Met inhibitor) Culver City, CA www.nantpharma.com
Ampligen® Hemispherx Biopharma solid tumors Phase I/II
rintatolimod Philadelphia, PA www.hemispherx.net
andecaliximab Gilead Sciences solid tumors Phase I
(MMP9 inhibitor mAb) Foster City, CA www.gilead.com
Medicines in Development: Cancer ǀ 2018 178
Solid TumorsProduct Name Sponsor Indication Development Phase
Andes-1537 Andes Biotechnologies advanced unresectable solid tumors Phase I
(antisense oligonucleotide) Santiago, Chile www.andesbio.com
anetumab ravtansine Bayer Pharmaceuticals mesothelin-expressing solid tumors Phase I
(antibody-drug conjugate) Whippany, NJ www.pharma.bayer.com
anti-CD27 agonist Aduro Biotech advanced solid tumors Phase I
Berkeley, CA (+/-pembrolizumab) www.aduro.com
Merck www.merck.com
Kenilworth, NJ
APG-115 Ascentage Pharma solid tumors Phase I
(MDM2-P53 inhibitor) Rockville, MD en.ascentagepharma.com
APG-1252 Ascentage Pharma solid tumors Phase I
(Bcl-2/Bcl-xl inhibitor) Rockville, MD en.ascentagepharma.com
APG-1387 Ascentage Pharma solid tumors Phase I
(IAP protein inhibitor) Rockville, MD en.ascentagepharma.com
APN401 Apeiron Biologics solid tumors Phase II
(siRNA-transfected peripheral Vienna, Austria www.apeiron-biologics.com
blood mononuclear cells)
APS001F Anaeropharma Science solid tumors Phase I/II
(cytosine deaminase gene therapy) Tokyo, Japan www.anaeropharma.co.jp
Medicines in Development: Cancer ǀ 2018 179
Solid TumorsProduct Name Sponsor Indication Development Phase
APX005M Apexigen solid tumors Phase I
(CD40 agonistic antibody) San Carlos, CA www.apexigen.com
APX3330 Apexian Pharmaceuticals advanced solid tumors Phase I
(small molecule quinone derivative) Indianapolis, IN www.apexianpharma.com
ARQ 751 ArQule solid tumors Phase I
(pan-AKT inhibitor) Burlington, MA www.arqule.com
ARRY 382 Array BioPharma advanced solid tumors Phase II
(CSF-1R kinase inhibitor) Boulder, CO (combination therapy) www.arraybiopharma.com
ASN002 Asana BioSciences solid tumors Phase I/II
(JAK/Syk inhibitor) Lawrenceville, NJ www.asanabiosciences.com
ASN003 Asana BioSciences solid tumors Phase I
(B-Raf/PI3K pathway inhibitor) Lawrenceville, NJ www.asanabiosciences.com
ASN007 Asana BioSciences solid tumors Phase I
(ERK 1/2 inhibitor) Lawrenceville, NJ www.asanabiosciences.com
ASP8374 (PTZ-201) Astellas solid tumors Phase I
(TIGIT antagonist) Northbrook, IL www.astellas.com
Potenza Therapeutics
Cambridge, MA
Medicines in Development: Cancer ǀ 2018 180
Solid TumorsProduct Name Sponsor Indication Development Phase
AST-008 Exicure solid tumors Phase I
(TLR9 agonist) Skokie, IL www.exicuretx.com
ASTX660 Astex Pharmaceuticals solid tumors Phase II
(IAP inhibitor) Pleasanton, CA www.astx.com
ATI-1123 Cytori Therapeutics solid tumors Phase I
(docetaxel liposomal) San Diego, CA www.cytori.com
AVB-S6-500 Aravive Biologics solid tumors Phase I
(GAS6-AXL pathway inhibitor) Houston, TX www.aravive.com
AVID100 IV Formation Biologics advanced solid tumors Phase I
(antibody-drug conjugate) Austin, TX www.formationbiologics.com
AvidinOx Alfasigma inoperable solid tumors Phase I
(177Lu-ST2210) Bologna, Italy www.alfasigma.com
AZD0156 AstraZeneca solid tumors Phase I
(ATM kinase inhibitor) Wilmington, DE www.astrazeneca.com
AZD1775 AstraZeneca advanced solid tumors Phase I
(WEE1 kinase inhibitor) Wilmington, DE www.astrazeneca.com
AZD2811 AstraZeneca solid tumors Phase I
(aurora B kinase inhibitor) Wilmington, DE www.astrazeneca.com
Medicines in Development: Cancer ǀ 2018 181
Solid TumorsProduct Name Sponsor Indication Development Phase
AZD4547 AstraZeneca solid tumors Phase II
(FGFR tyrosine kinase inhibitor) Wilmington, DE www.astrazeneca.com
AZD4635 AstraZeneca solid tumors Phase I
(adenosine A2A receptor antagonist) Wilmington, DE www.astrazeneca.com
AZD4785 (IONIS-KRAS-2.5RX) AstraZeneca solid tumors Phase I
(KRAS protein inhibitor) Wilmington, DE www.astrazeneca.com
Ionis Pharmaceuticals www.ionispharma.com
Carlsbad, CA
AZD5153 AstraZeneca solid tumors Phase I
(BRD4 protein inhibitor) Wilmington, DE www.astrazeneca.com
AZD6738 AstraZeneca solid tumors Phase I
(ATR protein inhibitor) Wilmington, DE www.astrazeneca.com
AZD8186 AstraZeneca solid tumors Phase I
(PI3 protein inhibitor) Wilmington, DE www.astrazeneca.com
Bavencio® EMD Serono solid tumors (+talazopanib) Phase I
avelumab Rockland, MA www.emdserono.com
(anti-PD-L1 inhibitor) Pfizer www.pfizer.com
New York, NY
BAY1436032 Bayer Pharmaceuticals IDH1-mutant solid tumors Phase I
(mutant-IDH1 inhibitor) Whippany, NJ www.pharma.bayer.com
Medicines in Development: Cancer ǀ 2018 182
Solid TumorsProduct Name Sponsor Indication Development Phase
BAY1895344 Bayer Pharmaceuticals solid tumors Phase I
(ATR protein inhibitor) Whippany, NJ www.pharma.bayer.com
BDB001 Birdie Biopharmaceuticals solid tumors (+/-pembrolizumab) Phase I
(TLR agonist) Beijing, China
Beleodaq® Spectrum Pharmaceuticals UGT1A1 wild type gene solid tumors, Phase I
belinostat Henderson, NV UGT1A1*28 genotype solid tumors www.sppirx.com
BI 754091 Boehringer Ingelheim Pharmaceuticals solid tumors Phase I
(anti-PD-1 mAb) Ridgefield, CT www.boehringer-ingelheim.com
BI 754111 Boehringer Ingelheim Pharmaceuticals solid tumors Phase I
(anti-LAG3 mAb) Ridgefield, CT www.boehringer-ingelheim.com
BI 836880 Boehringer Ingelheim Pharmaceuticals solid tumors Phase I
(VEGF/Ang2 bispecific nanobody) Ridgefield, CT www.boehringer-ingelheim.com
BI 891065 Boehringer Ingelheim Pharmaceuticals solid tumors Phase I
(SMAC mimetic) Ridgefield, CT www.boehringer-ingelheim.com
BI 894999 Boehringer Ingelheim Pharmaceuticals solid tumors Phase I
(BET protein inhibitor) Ridgefield, CT www.boehringer-ingelheim.com
birinapant Medivir solid tumors (+pembrolizumab) Phase I/II
(SMAC mimetic) Stockholm, Sweden www.medivir.se
Medicines in Development: Cancer ǀ 2018 183
Solid TumorsProduct Name Sponsor Indication Development Phase
BLU-667 Blueprint Medicines solid tumors Phase I
(RET inhibitor) Cambridge, MA www.blueprintmedicines.com
BLZ945 Novartis Oncology advanced solid tumors Phase I
(CSF-1R antagonist) East Hanover, NJ www.novartis.com
BMS-813160 Bristol-Myers Squibb advanced solid tumors Phase I
(CCR2/5 dual antagonist) Princeton, NJ www.bms.com
BMS-986148 Bristol-Myers Squibb advanced solid tumors (+nivolumab) Phase I
(mesothelin directed antibody Princeton, NJ www.bms.com
drug conjugate)
BMS-986156 Bristol-Myers Squibb solid tumors Phase I/II
(anti-GITR mAb) Princeton, NJ www.bms.com
BMS-986158 Bristol-Myers Squibb solid tumors Phase I
(BET inhibitor) Princeton, NJ www.bms.com
BMS-986178 Bristol-Myers Squibb solid tumors Phase I
(anti-OX40 antibody) Princeton, NJ www.bms.com
BMS-986179 Bristol-Myers Squibb solid tumors Phase I
(anti-CD73 mAb) Princeton, NJ www.bms.com
Medicines in Development: Cancer ǀ 2018 184
Solid TumorsProduct Name Sponsor Indication Development Phase
BMS-986205 Bristol-Myers Squibb solid tumors (+nivolumab), Phase I
(IDO1 inhibitor) Princeton, NJ solid tumors (+nivolumab +ipilimumab) www.bms.com
BMS-986207 Bristol-Myers Squibb solid tumors (+nivolumab) Phase I
(anti-TIGHT mAb) Princeton, NJ www.bms.com
BMS-986218 Bristol-Myers Squibb solid tumors Phase I
(anti-CTLA-4 mAb) Princeton, NJ www.bms.com
BMS-986226 Bristol-Myers Squibb solid tumors Phase I
(anti-ICOS mAb) Princeton, NJ www.bms.com
BMS-986242 Bristol-Myers Squibb solid tumors Phase I
Princeton, NJ www.bms.com
BMS-986249 Bristol-Myers Squibb solid tumors Phase I
(anti-CTLA- 4 probody) Princeton, NJ www.bms.com
BMS-986253 Bristol-Myers Squibb solid tumors (+nivolumab) Phase I/II
(HuMax-IL8 mAb) Princeton, NJ www.bms.com
BMS-986258 Bristol-Myers Squibb advanced solid tumors (+/-nivolumab) Phase I
(immunotherapy) Princeton, NJ www.bms.com
BMS-986299 Bristol-Myers Squibb advanced solid tumors Phase I
(immunotherapy) Princeton, NJ (+/-nivolumab +ipilimumab) www.bms.com
Medicines in Development: Cancer ǀ 2018 185
Solid TumorsProduct Name Sponsor Indication Development Phase
BN-brachyury cancer vaccine Bavarian Nordic solid tumors Phase I
(prime-boost immunotherapy) Morrisville, NC www.bavarian-nordic.com
National Cancer Institute
Bethesda, MD
BOS172722 Boston Pharmaceuticals solid tumors Phase I
(TTK protein inhibitor) Cambridge, MA www.bostonpharmaceuticals.com
BPM31510 Berg solid tumors Phase I
(cancer cell metabolism restorer) Framingham, MA www.berghealth.com
briciclib Onconova Therapeutics solid tumors Phase I
(cyclin D1 inhibitor) Newtown, PA www.onconova.com
BSK01™ Kiromic relapsed/refractory solid tumors Phase I/II
(tumor-associated peptide antigen Houston, TX www.kiromic.com
pulsed dendritic cell vaccine)
BTP-114 Placon Therapeutics solid tumors Phase I
(DNA cross linking agent) Cambridge, MA www.placontx.com
BTRC4017A Genentech HER2-expressing solid tumors Phase I
South San Francisco, CA www.gene.com
BVD-523 BioMed Valley Discoveries advanced solid tumors Phase I/II
(ERK inhibitor) Kanas City, MO www.biomed-valley.com
Medicines in Development: Cancer ǀ 2018 186
Solid TumorsProduct Name Sponsor Indication Development Phase
BXCL701 (talabostat) BioXcel Therapeutics solid tumors Phase I
(DPP 8/9 & FAP Inhibitor) Branford, CT www.bioxcel.com
BXQ-350 Bexion Pharmaceuticals solid tumors Phase I
(apoptosis stimulant) Covington, KY www.bexionpharma.com
C188-9 StemMed solid tumors Phase I
(STAT3 inhibitor) Houston, TX www.stemmedcancer.com
CA-170 Curis solid tumors Phase I
(PD-L1 checkpoint inhibitor) Lexington, MA www.curis.com
CAB-AXL-ADC BioAtla solid tumors Phase I/II
(anti-AXL antibody-drug conjugate) San Diego, CA www.bioatla.com
CAB-ROR2-ADC BioAtla solid tumors Phase I/II
(anti-ROR2 antibody-drug conjugate) San Diego, CA www.bioatla.com
cabiralizumab Five Prime Therapeutics solid tumors (+nivolumab) Phase II
(anti-CSF1R) South San Francisco, CA www.fiveprime.com
Bristol-Myers Squibb
Princeton, NJ
Cabometyx™ Exelixis advanced solid tumors (+atezolizumab) Phase I
cabozantinib South San Francisco, CA www.exelixis.com
Medicines in Development: Cancer ǀ 2018 187
Solid TumorsProduct Name Sponsor Indication Development Phase
camptothecin (CRLX101) BlueLink Pharmaceuticals advanced solid tumors Phase I
Ames, IA
CB-5083 Cleave Biosciences solid tumors Phase I
(p97 inhibitor) Burlingame, CA www.cleavebio.com
CB-839 Calithera Biosciences solid tumors (+nivolumab) Phase II
(glutaminase inhibitor) South San Francisco, CA www.calithera.com
CBLC137 Incuron solid tumors Phase I
(curaxin) Buffalo, NY www.incuron.com
CBP501 CanBas advanced solid tumors Phase I
(peptide mimetic) Numazu, Japan www.canbas.co.jp
CBT-101 CBT Pharmaceuticals solid tumors Phase I
(c-Met inhibitor) Pleasanton, CA www.cbtpharma.com
CBT-101 + CBT-501 CBT Pharmaceuticals solid tumors Phase I
(c-Met + anti-PD-1) Pleasanton, CA www.cbtpharma.com
CBT-501 (genolimzumab) CBT Pharmaceuticals solid tumors Phase I
(anti-PD-1 mAb) Pleasanton, CA www.cbtpharma.com
CBT-501 + CBT-502 CBT Pharmaceuticals solid tumors Phase I
(anti-PD-1 + anti-PD-L1) Pleasanton, CA www.cbtpharma.com
Medicines in Development: Cancer ǀ 2018 188
Solid TumorsProduct Name Sponsor Indication Development Phase
CC-90002 Celgene solid tumors Phase I
(anti-CD47 antibody) Summit, NJ www.celgene.com
CC-90010 Celgene solid tumors Phase I
(BET inhibitor) Summit, NJ www.celgene.com
CC-90011 Celgene solid tumors Phase I
(LSD1 inhibitor) Summit, NJ www.celgene.com
CDX-0158 Celldex Therapeutics solid tumors Phase I
(anti-KIT IgG1 antibody-drug conjugate) Hampton, NJ www.celldex.com
CDX-1140 Celldex Therapeutics advanced solid tumors Phase I
(anti-CD40 mAb) Hampton, NJ www.celldex.com
ceramide nanoliposome Keystone Nano solid tumors Phase I/II
State College, PA www.keystonenano.com
CGX1321 Curegenix solid tumors Phase I
Burlingame, CA
CK-301 Checkpoint Therapeutics solid tumors Phase I
(anti-PD-L1 mAb) New York, NY www.checkpointtx.com
CMB305 Immune Design NY-ESO-1-expressing solid tumors Phase II
(antigen-specific prime boost) Seattle, WA www.immunedesign.com
Medicines in Development: Cancer ǀ 2018 189
Solid TumorsProduct Name Sponsor Indication Development Phase
CNV-NT BioMed Valley Discoveries solid tumors Phase I
(clostridium novyi -NT) Kansas City, MO www.biomed-valley.com
COH29 Novonco Therapeutics solid tumors Phase I
(ribonucleoside reductase inhibitor) Los Angeles, CA www.novoncotherapeutics.com
CPX-POM CicloMed advanced solid tumors Phase I
(ciclopirox prodrug) Kansas City, MO www.ciclomed.com
CRLX301 BlueLink Pharmaceuticals solid tumors Phase I/II
(docetaxel) Ames, IA
Crolibulin™ Cytovia solid tumors Phase I/II
vascular disrupting agent Englewood Cliffs, NJ www.immunepharma.com
CX-072 CytomX Therapeutics solid tumors Phase I/II
(PD-L1 targeting probody) South San Francisco, CA www.cytomix.com
CX-2009 CytomX Therapeutics solid tumors Phase I/II
(CD166-targeting probody- South San Francisco, CA www.cytomx.com
drug conjugate)
CYAD-01 Celyad solid tumors Phase I
(NKG2D CAR-T cell therapy) New York, NY www.celyad.com
Medicines in Development: Cancer ǀ 2018 190
Solid TumorsProduct Name Sponsor Indication Development Phase
CYC065 Cyclacel Pharmaceuticals solid tumors Phase I
(CDK2/CDK9 inhibitor) Berkeley Heights, NJ www.cyclacel.com
CYT-6091 CytImmune Sciences solid tumors Phase I completed
(nanotherapy comprised of cAU Rockville, MD www.cytimmune.com
particles, tumor necrosis factor,
PEG-Thiol)
CZ48 Cao Pharmaceuticals solid tumors Phase I
(DNA topoisomerase I inhibitor) Webster, TX www.caopharmaceuticals.com
NMT Pharmaceuticals
Webster, TX
DCC-2618 Deciphera Pharmaceuticals solid tumors Phase I
(PDGFR-alpha kinase switch Waltham, MA www.deciphera.com
control inhibitor)
DCC-3014 Deciphera Pharmaceuticals solid tumors Phase I
(CSF1R inhibitor) Waltham, MA www.deciphera.com
DCVax®-Direct Northwest Biotherapeutics solid tumors Phase I/II
cancer vaccine Bethesda, MD www.nwbio.com
derazantinib (ARQ 087) ArQule solid tumors Phase I
(FGFR antagonist) Burlington, MA www.arqule.com
Basilea Pharmaceutica
Basel, Switzerland
Medicines in Development: Cancer ǀ 2018 191
Solid TumorsProduct Name Sponsor Indication Development Phase
DFP 13318 Delta-Fly Pharma solid tumors Phase I
(DNA topoisomerase I inhibitor) Tokushima, Japan www.delta-flypharma.co.jp
DSP-0509 Sumitomo Dainippon Pharma solid tumors Phase I
(TLR-7 agonist) Osaka, Japan www.ds-pharma.com
DSP-7888 Sumitomo Dainippon Pharma solid tumors Phase I
(adegramotide/nelatimotide) Osaka, Japan www.ds-pharma.com
eFT508 eFFECTOR Therapeutics advanced solid tumors Phase I/II
(MKNK1/MKNK2 protein inhibitor) San Diego, CA www.effector.com
Elenagen™ CureLab Oncology solid tumors Phase I/II completed
p62 anti-cancer DNA Vaccine Boston, MA www.curelaboncology.com
emactuzumab (RG7155) Roche/Genentech solid tumors (+atezolizumab), Phase I
(mCS- receptor antagonist) South San Francisco, CA solid tumors (+selicrelumab) www.gene.com
enadenotucirev PsiOxus Therapeutics solid tumors (+nivolumab) Phase I
(oncolytic virus therapeutic) Plymouth Meeting, PA www.psioxus.com
enoblituzumab MacroGenics solid tumors (+anti-PD-1) Phase II
(anti-B7-H3 IgG1/κ mAb) Rockville, MD www.macrogenics.com
entolimod Cleveland BioLabs advanced solid tumors Phase I
(TLR5 agonist) Buffalo, NY www.cbiolabs.com
Medicines in Development: Cancer ǀ 2018 192
Solid TumorsProduct Name Sponsor Indication Development Phase
entrectinib Ignyta NTRK-positive extracranial solid tumors Phase I
(panTRK/ROS1 inhibitor) San Diego, CA www.ignyta.com
ORPHAN DRUG
ERY974 Chugai Pharmaceutical advanced solid tumors Phase I
(anti-glypican3/CD3 bispecific antibody) Tokyo, Japan www.chugai-pharm.co.jp
ETC-1922159 Biomedical Sciences Institute solid tumors Phase I
(PORCN protein inhibitor) Singapore www.a-star.edu.sg/d3
D3 (Drug Product and Development)
Singapore
FATE-NK100 Fate Therapeutics solid tumors (combination therapy) Phase I
(natural killer cell stimulant) La Jolla, CA www.fatetherapeutics.com
FAZ053 Novartis Oncology advanced solid tumors (+/- PDR001) Phase I
(anti-PD-L1 mAb) East Hanover, NJ www.novartis.com
fenretinide intravenous CerRx solid tumors (adults) Phase II
Lubbock, TX www.cerrx.com
mixed tumors (pediatric) Phase I
www.cerx.com
FF-10502-01 FUJIFILM Pharmaceuticals U.S.A. solid tumors Phase I
(DNA synthesis inhibitor) Cambridge, MA www.fujifilmusa.com
Medicines in Development: Cancer ǀ 2018 193
Solid TumorsProduct Name Sponsor Indication Development Phase
FF-21101 FUJIFILM Pharmaceuticals U.S.A. solid tumors Phase I
(Y-90 radiolabeled mAb) Cambridge, MA www.fujifilmusa.com
FGF401 Novartis Oncology solid tumors Phase I/II
(FGFR4 antagonist) East Hanover, NJ www.novartis.com
fimepinostat (CUDC-907) Curis solid tumors Phase I
(HDAC/PI3K inhibitor) Lexington, MA www.curis.com
FLX475 FLX Bio solid tumors Phase I
(CCR4 receptor antagonist) South San Francisco, CA www.flxbio.com
FPA150 Five Prime Therapeutics solid tumors Phase I
(B7-H4 antibody) South San Francisco, CA www.fiveprime.com
fruquintinib Hutchison MediPharma advanced solid tumors Phase I
(VEGFR inhibitor) Shanghai, China www.hmplglobal.com
galinpepimut-S Sellas Life Sciences solid tumors (+pembrolizumab) Phase I
(anti-WT1 peptide cancer vaccine) New York, NY www.sellaslifesciences.com
galunisertib Eli Lilly advanced refractory solid tumors Phase I/II
(TGF-beta 1 inhibitor) Indianapolis, IN (+nivolumab) www.lilly.com
GDC-0077 (RG6114) Genentech solid tumors Phase I
(PI3K inhibitor) South San Francisco, CA www.gene.com
Medicines in Development: Cancer ǀ 2018 194
Solid TumorsProduct Name Sponsor Indication Development Phase
GDC-0575 (RG7741) Array BioPharma solid tumors Phase I
(ChK1 inhibitor) Boulder, CO www.gene.com
Genentech
South San Francisco, CA
GDC-5573 (RG6185) Genentech solid tumors Phase I
(RAF inhibitor) South San Francisco, CA www.gene.com
glesatinib (MGCD265) Mirati Therapeutics advanced solid tumors Phase I
(multi-kinase inhibitor) San Diego, CA www.mirati.com
GL-ONC1 Genelux solid tumors Phase II
(oncolytic virus therapy) San Diego, CA www.genelux.com
GMI-1359 GlycoMimetics solid tumors Phase I
(E-selectin/CXCR4 inhibitor) Rockville, MD www.glycomimetics.com
GS-5829 Gilead Sciences solid tumors Phase I
(BET inhibitor) Foster City, CA www.gilead.com
GSK1795091 GlaxoSmithKline solid tumors Phase I
(TLR4 agonist) Research Triangle Park, NC www.gsk.com
GSK3174998 GlaxoSmithKline solid tumors Phase I
(anti-OX40 mAb) Research Triangle Park, NC www.gsk.com
Medicines in Development: Cancer ǀ 2018 195
Solid TumorsProduct Name Sponsor Indication Development Phase
GSK3326595 GlaxoSmithKline solid tumors Phase I
(PRMT5 inhibitor) Research Triangle Park, NC www.gsk.com
GSK3359609 GlaxoSmithKline solid tumors Phase I
(induced T-cell costimulator Research Triangle Park, NC www.gsk.com
agonist antibody)
GSK525762 (molibresib) GlaxoSmithKline solid tumors Phase I
(BET inhibitor) Research Triangle Park, NC www.gsk.com
guadecitabine (SGI-110) Astex Pharmaceuticals solid tumors Phase II
(DNMT1 inhibitor) Pleasanton, CA www.astx.com
GWN323 Novartis Oncology solid tumors (+PDR001) Phase I
(anti-C+GITR mAb) East Hanover, NJ www.novartis.com
haNK for infusion NantKwest solid tumors Phase I
(nature killer cells) Culver City, CA www.nantkwest.com
HDM201 Novartis Oncology solid tumors Phase I
(p53-HDM2 inhibitor) East Hanover, NJ www.novartis.com
HTI-1066 Jiangsu Hengrui Medicine advanced solid tumors Phase I
(antibody-drug conjugate) Jiangsu, China www.hrs.com.cn
Medicines in Development: Cancer ǀ 2018 196
Solid TumorsProduct Name Sponsor Indication Development Phase
Hu5F9-G4 Forty Seven solid tumors Phase I
(CD47 antigen inhibitor mAb) Menlo Park, CA www.fortyseveninc.com
HuMax-AXL-ADC Genmab solid tumors Phase I/II
(anti-AXL antibody-drug conjugate) Princeton, NJ www.seattlegenetics.com
Seattle Genetics
Bothell, WA
IDO inhibitor(2) Bristol-Myers Squibb solid tumors Phase I
Princeton, NJ www.bms.com
IM156 ImmunoMet solid tumors Phase I
(OXPHOS inhibitor) Houston, TX www.immunomet.com
IMA101 Immatics US solid tumors Phase I
(adoptive T-cell therapy) Houston, TX www.immatics.com
IMA202 Immatics US solid tumors Phase I
(adoptive T-cell therapy) Houston, TX www.immatics.com
Imbruvica® Janssen Research & Development solid tumors Phase II
ibrutinib Raritan, NJ www.janssen.com
Pharmacyclics www.pharmacyclics.com
Sunnyvale, CA
Medicines in Development: Cancer ǀ 2018 197
Solid TumorsProduct Name Sponsor Indication Development Phase
Imfinzi® MedImmune solid tumors (+MEDI0680), Phase II
durvalumab Gaithersburg, MD solid tumors (monotherapy) www.medimmune.com
solid tumors (+AZD1775), Phase I
solid tumors (+MEDI0562), www.medimmune.com
solid tumors (+MEDI9197),
solid tumors (+monalizumab),
solid tumors (+oleclumab),
solid tumors (+selumetinib),
solid tumors (+tremelimumab)
solid tumors (+AZD9150 +chemotherapy)
Imlygic® Amgen pediatric non-CNS tumors Phase I
talimogene laherparepvec Thousand Oaks, CA www.amgen.com
IMX-110 Immix Biopharma solid tumors Phase I/II
(STAT3/NF-kB/poly-tyrosine kinase Los Angeles, CA www.immixbio.com
inhibitor, curcumin and low-dose
doxorubicin nanotherapy)
INCAGN1876 Agenus solid tumors Phase I/II
(anti-GITR antibody) Lexington, MA www.agenus.com
Incyte www.incyte.com
Wilmington, DE
INCAGN1949 Agenus solid tumors Phase I/II
(anti-OX40 antibody) Lexington, MA www.agenus.com
Incyte www.incyte.com
Wilmington, DE
Medicines in Development: Cancer ǀ 2018 198
Solid TumorsProduct Name Sponsor Indication Development Phase
INCB01158 Calithera Biosciences solid tumors (+checkpoint inhibitor), Phase I
(arginase inhibitor) South San Francisco, CA solid tumors (+chemotherapy), www.calithera.com
Incyte solid tumors (+epacadostat)
Wilmington, DE
INO-1400 Inovio Pharmaceuticals solid tumors Phase I
(hTERT DNA cancer vaccine) Plymouth Meeting, PA www.inovio.com
INT230-6 Intensity Therapeutics solid tumors Phase I/II
(cisplatin-based intratumoral Westport, CT www.intensitytherapeutics.com
cancer vaccine)
IPI-549 Infinity Pharmaceuticals solid tumors (monotherapy), Phase I
(PI3K-gamma inhibitor) Cambridge, MA solid tumors (+nivolumab) www.infi.com
IT-139 Intezyne solid tumors Phase I
(cancer resistance pathway inhibitor) Tampa, FL www.intezyne.com
IT-141 Intezyne solid tumors Phase I
(TOP-1 inhibitor) Tampa, FL www.intezyne.com
JNJ 63723283 Janssen Research & Development advanced solid tumors Phase I
(anti-PD-1 mAb) Raritan, NJ www.janssen.com
JNJ-64457107 (ADC-1013) Janssen Research & Development solid tumors Phase I
(IgG1 antibody immunotherapy) Raritan, NJ www.janssen.com
Medicines in Development: Cancer ǀ 2018 199
Solid TumorsProduct Name Sponsor Indication Development Phase
JTX-2011 Jounce Therapeutics solid tumors Phase II
(ICOS agonist) Cambridge, MA www.jouncetx.com
KA2507 Karus Therapeutics solid tumors Phase I
(HDAC6-selective inhibitor) Oxfordshire, United Kingdom www.karustherapeutics.com
Keytruda® Merck advanced solid tumors Phase IIpembrolizumab Kenilworth, NJ www.merck.com
KHK2455 Kyowa Kirin solid tumors Phase I
(IDO-1 inhibitor) Princeton, NJ www.kyowa-kirin.com
KITE-718 Kite Pharma solid tumors Phase I
(MAGE A3/A6 T-cell therapy) Santa Monica, CA www.kitepharma.com
KN035 Alphamab solid tumors Phase I
(anti-PD-L1 mAb) Suzhou, China www.3dmedcare.com
3D Medicines
Shanghai, China
KO-947 Kura Oncology solid tumors Phase I
(ERK inhibitor) San Diego, CA www.kuraoncology.com
KPT-9274 Karyopharm Therapeutics solid tumors Phase I
(PAK4/NAMPT oral inhibitor) Newton, MA www.karyopharm.com
Medicines in Development: Cancer ǀ 2018 200
Solid TumorsProduct Name Sponsor Indication Development Phase
LAG525 Novartis Oncology solid tumors Phase I/II
(anti-LAG3 mAb) East Hanover, NJ www.novartis.com
LB-100 Lixte Biotechnology solid tumors (combination therapy) Phase I
(PP2A inhibitor) East Setauket, NY www.lixte.com
lefitolimod (MGN1703) Mologen advanced solid tumors (+ipilimumab) Phase I
(DNA-based TLR9 agonist) Berlin, Germany www.mologen.com
M.D. Anderson Cancer Center
Houston, TX
Lenvima® Eisai solid tumors (+pembrolizumab) Phase I/II
lenvatinib Woodcliff Lake, NJ www.eisai.com
LGK974 Novartis Oncology Wnt ligand dependent tumors Phase I
(PORCN protein inhibitor) East Hanover, NJ www.novartis.com
lirilumab Bristol-Myers Squibb advanced solid tumors Phase I/II
(anti-KIR mAb) Princeton, NJ (+nivolumab +ipilimumab) www.bms.com
LOXO-292 Loxo Oncology solid tumors Phase I
(RET kinase inhibitor) Stamford, CT www.loxooncology.com
LTT462 Novartis Oncology advanced solid tumors Phase I
(MAP kinase inhibitor) East Hanover, NJ www.novartis.com
Medicines in Development: Cancer ǀ 2018 201
Solid TumorsProduct Name Sponsor Indication Development Phase
lupartumab amadotin Bayer Pharmaceuticals solid tumors Phase I
(C4-4a antibody-drug conjugate) Whippany, NJ www.pharma.bayer.com
lurbinectedin (PM1183) PharmaMar advanced solid tumors Phase II
(RNA polymerase II inhibitor) Madrid, Spain www.pharmamar.com
LY3022855 (IMC-CS4) Eli Lilly solid tumors Phase I
(CSF-1R mAb) Indianapolis, IN www.lilly.com
LY3023414 Eli Lilly advanced solid tumors Phase I
(PI3K/mTOR inhibitor) Indianapolis, IN www.lilly.com
LY3039478 Eli Lilly advanced or metastatic solid tumors Phase I
(NOTCH inhibitor) Indianapolis, IN (combination therapy) www.lilly.com
LY3127804 Eli Lilly solid tumors Phase I
(Ang2 antibody) Indianapolis, IN www.lilly.com
LY3200882 Eli Lilly solid tumors Phase I
(TGF-betaR1 kinase inhibitor) Indianapolis, IN www.lilly.com
LY3214996 Eli Lilly solid tumors Phase I
(ERK1/2 inhibitor) Indianapolis, IN www.lilly.com
LY3300054 Eli Lilly solid tumors Phase I
(PD-L1 antibody) Indianapolis, IN www.lilly.com
Medicines in Development: Cancer ǀ 2018 202
Solid TumorsProduct Name Sponsor Indication Development Phase
LY3321367 Eli Lilly solid tumors (+/-LY3300054) Phase I
(TIM-3 antibody) Indianapolis, IN www.lilly.com
LY3381916 Eli Lilly solid tumors (+/-PD-L1) Phase I
(IDO-1 inhibitor) Indianapolis, IN www.lilly.com
LYC-55716 Lycera solid tumors Phase II
(ROR-gamma agonist) Ann Arbor, MI www.lycera.com
Lynparza® AstraZeneca solid tumors (+durvalumab) Phase II
olaparib Wilmington, DE www.astrazeneca.com
solid tumors (+AZD1775) Phase I
www.astrazeneca.com
LZM009 Livzon Pharmaceutical solid tumors Phase I
(anti-PD-1 mAb) Zhuhai City, China
M2698 EMD Serono solid tumors Phase I
(p70S6K/AKT inhibitor) Rockland, MA www.emdserono.com
M3541 EMD Serono solid tumors Phase I
(ATM inhibitor) Rockland, MA www.emdserono.com
M3814 EMD Serono solid tumors Phase I
(DNA-PK inhibitor) Rockland, MA www.emdserono.com
Medicines in Development: Cancer ǀ 2018 203
Solid TumorsProduct Name Sponsor Indication Development Phase
M4112 EMD Serono solid tumors Phase II
(cancer immunotherapy) Rockland, MA www.emdserono.com
M4344 (VX-803) EMD Serono solid tumors Phase I
(ATR inhibitor) Rockland, MA www.emdserono.com
Vertex Pharmaceuticals
Boston, MA
M6620 (VX-970) EMD Serono solid tumors Phase I
(ATR inhibitor) Rockland, MA www.emdserono.com
Vertex Pharmaceuticals
Boston, MA
M7824 EMD Serono solid tumors Phase II
(PD-L1 / TGF-beta inhibitor) Rockland, MA www.emdserono.com
M8891 EMD Serono solid tumors Phase I
(MetAP2 inhibitor) Rockland, MA www.emdserono.com
M9241 (NHS-IL12) EMD Serono solid tumors Phase I
(IL-12 stimulant) Rockland, MA www.emdserono.com
M9831 EMD Serono solid tumors Phase I
(DNA-PK inhibitor) Rockland, MA www.emdserono.com
MAGE-A4 TCR Adaptimmune solid tumors Phase I
(T-cell receptor cell therapy) Philadelphia, PA www.adaptimmune.com
Medicines in Development: Cancer ǀ 2018 204
Solid TumorsProduct Name Sponsor Indication Development Phase
MBG453 Novartis Oncology solid tumors Phase I/II
(anti-TIM3 antibody) East Hanover, NJ www.novartis.com
MEDI1873 MedImmune solid tumors Phase I
(GITR agonist fusion protein) Gaithersburg, MD www.medimmune.com
MEDI4276 MedImmune solid tumors Phase I
(ERBB 2 receptor modulator) Gaithersburg, MD www.medimmune.com
MEDI5083 MedImmune solid tumors Phase I
(immune activator) Gaithersburg, MD www.medimmune.com
MEDI9197 MedImmune solid tumors Phase I
(TLR7/8 agonist) Gaithersburg, MD www.medimmune.com
MGA012 (INCMGA0012) Incyte solid tumors Phase I
(anti-PD-1 mAb) Wilmington, DE www.incyte.com
MacroGenics www.macrogenics.com
Rockville, MD
MGD009 MacroGenics solid tumors (monotherapy), Phase I
(B7-H3 x CD3 bispecific antibody) Rockville, MD solid tumors (+MGA012) www.macrogenics.com
MGD013 MacroGenics solid tumors Phase I
(anti-PD-1 mAb x LAG-3) Rockville, MD www.macrogenics.com
Medicines in Development: Cancer ǀ 2018 205
Solid TumorsProduct Name Sponsor Indication Development Phase
minnelide Minneamrita Therapeutics advanced solid tumors Phase I
(HSP70 heat shock protein inhibitor) Tampa, FL
miransertib (ARQ-092) ArQule solid tumors Phase I
(pan-AKT inhibitor) Burlington, MA www.arqule.com
mivebresib (ABBV-075) AbbVie solid tumors Phase I
(BET inhibitor) North Chicago, IL www.abbvie.com
MK-1248 Merck advanced solid tumors Phase I
Kenilworth, NJ (+/-pembrolizumab) www.merck.com
MK-1308 Merck solid tumors Phase I
(CTLA-4 antagonist) Kenilworth, NJ www.merck.com
MK-1454 Merck solid tumors Phase I
(STING agonist) Kenilworth, NJ www.merck.com
MK-2118 Merck solid tumors (+/-pembrolizumab) Phase I
Kenilworth, NJ www.merck.com
MK-4166 Merck solid tumors (+/-pembrolizumab) Phase I
(GITR protein stimulant) Kenilworth, NJ www.merck.com
MK-4280 Merck solid tumors (+/-pembrolizumab) Phase I
(anti-LAG3 mAb) Kenilworth, NJ www.merck.com
Medicines in Development: Cancer ǀ 2018 206
Solid TumorsProduct Name Sponsor Indication Development Phase
MK-5890 Merck solid tumors (+/-pembrolizumab) Phase I
Kenilworth, NJ www.merck.com
MK-7123 (navarixin) Merck advanced solid tumors Phase I
(CXCR2/CXCR1 antagonist) Kenilworth, NJ (+pembrolizumab) www.merck.com
MK-7162 Merck solid tumors (+pembrolizumab) Phase I
Kenilworth, NJ www.merck.com
MK-7252 Merck advanced solid tumors Phase I
Kenilworth, NJ www.merck.com
MK-7684 Merck advanced solid tumors Phase I
(anti-TIGIT) Kenilworth, NJ (+/-pembrolizumab) www.merck.com
MK-8353 Merck advanced solid tumors (+pembrolizumab) Phase I
(ERK inhibitor) Kenilworth, NJ www.merck.com
MM-310 Merrimack Pharmaceuticals solid tumors Phase I
(antibody-directed nanotherapeutic Cambridge, MA www.merrimack.com
targeting EphA2 receptor)
mogamulizumab Kyowa Hakko Kirin solid tumors (+ docetaxel), Phase I
(CCR4 receptor antagonist) Princeton, NJ solid tumors (+nivolumab) www.kyowa-kirin.com
solid tumors
(+ durvalumab + tremelimumab)
Medicines in Development: Cancer ǀ 2018 207
Solid TumorsProduct Name Sponsor Indication Development Phase
MORAb-066 Eisai solid tumors Phase I
(anti-TF IgG mAb) Woodcliff Lake, NJ www.eisai.com
MORAb-202 Eisai solid tumors Phase I
(antibody-drug conjugate) Woodcliff Lake, NJ www.eisai.com
mRNA-2416 Moderna Therapeutics solid tumors Phase I
(OX40L protein modulator) Cambridge, MA www.modernatx.com
mRNA-4157 Moderna Therapeutics solid tumors Phase I
(personalized cancer vaccine) Cambridge, MA www.modernatx.com
MS201408-0005A EMD Serono solid tumors Phase I
Rockland, MA www.emdserono.com
MS201408-0005B EMD Serono solid tumors Phase I
Rockland, MA www.emdserono.com
MS201408-0005C EMD Serono solid tumors Phase I
Rockland, MA www.emdserono.com
MSB2311 MabSpace Biosciences solid tumors Phase I
(anti-PD-L1 antibody) Suzhou, China www.mabspacebio.com
MTIG7192A (RG6058) Genentech solid tumors Phase I
(anti-TIGIT mAb) South San Francisco, CA www.gene.com
Medicines in Development: Cancer ǀ 2018 208
Solid TumorsProduct Name Sponsor Indication Development Phase
MVA p53 vaccine Tara Immuno-Oncology solid tumors Phase I
(modified vaccinia virus ankara New York, NY
vaccine expressing p53)
MVT-1075 MabVax Therapeutics CA19-9-expressing solid tumors Phase I
(177Lu mAB 5B1/radio- San Diego, CA www.mabvax.com
imunotherapy)
MVT-5873 MabVax Therapeutics CA19-9-expressing solid tumors, Phase I
(5B1 mAb) San Diego, CA CA19-9-expressing tumors www.mabvax.com
(+ chemotherapy)
napabucasin Boston Biomedical solid tumors Phase I/II
(STAT3 inhibitor) Cambridge, MA (+immune checkpoint inhibitors) www.bostonbiomedical.com
advanced solid tumors (+amcasertib) Phase I
www.bostonbiomedical.com
NBT-011 (ABI-011) NantBioScience solid tumors Phase I
(angiogenesis inhibitor) Culver City, CA www.nantworks.com
NC-6300 NanoCarrier advanced solid tumors Phase I
(epirubicin micelle) Chiba, Japan www.nanocarrier.co.jp
NEV-801 Neovia Oncology solid tumors Phase I
(camptothecin/podophyllotoxin) Bellevue, WA www.neoviaoncology.com
Medicines in Development: Cancer ǀ 2018 209
Solid TumorsProduct Name Sponsor Indication Development Phase
NG-348 Bristol-Myers Squibb solid tumors Phase I
(CD80/CD3 T-SIGn oncolytic virus) Princeton, NJ www.bms.com
PsiOxus Therapeutics www.psioxus.com
Plymouth Meeting, PA
NIR178 Novartis Oncology solid tumors (+ PDR001) Phase II
(adenosine receptor antagonist) East Hanover, NJ www.novartis.com
NIS793 Novartis Oncology solid tumors (+PDR001) Phase I
(TGF-beta inhibitor) East Hanover, NJ www.novartis.com
NIZ985 Novartis Oncology advanced or metastatic Phase I
(heterodimeric IL-15) East Hanover, NJ solid tumors (+ PDR001) www.novartis.com
NKTR-214 Nektar Therapeutics advanced solid tumors, Phase I/II
(CD122-biased immune- San Francisco, CA advanced solid tumors (+NKTR-262), www.nektar.com
stimulatory cytokine) advanced solid tumors (+nivolumab)
advanced solid tumors (+atezolizumab), Phase I
advanced solid tumors (+pembrolizumab) www.nektar.com
NKTR-262 Nektar Therapeutics advanced solid tumors Phase I
(TLR 7/8 agonist) San Francisco, CA www.nektar.com
NLG802 NewLink Genetics advanced solid tumors Phase I
(IDO inhibitor) Ames, IA www.newlinkgenetics.com
Medicines in Development: Cancer ǀ 2018 210
Solid TumorsProduct Name Sponsor Indication Development Phase
NP-G2-044 Novita Pharmaceuticals solid tumors Phase I
(metastasis inhibitor) New York, NY
OBP-801 Oncolys BioPharma solid tumors Phase I
(HDAC inhibitor) Tokyo, Japan www.oncolys.com
oleclumab (MEDI9447) MedImmune solid tumors Phase I
(nucleotidase inhibitor) Gaithersburg, MD www.medimmune.com
OMP-313M32 OncoMed Pharmaceuticals solid tumors Phase I
(anti-TIGIT mAb) Redwood City, CA www.oncomed.com
OMP-336B11 OncoMed Pharmaceuticals solid tumors Phase I
(GITRL-Fc fusion protein) Redwood City, CA www.oncomed.com
ONC201 Oncoceutics solid tumors Phase I
(dopamine receptor D2/3 antagonist) Philadelphia, PA www.oncoceutics.com
ONO-4578 Bristol-Myers Squibb solid tumors Phase I
(EP4 antagonist) Princeton, NJ www.bms.com
ONO-7579 Ono Pharmaceutical solid tumors Phase I/II
(Trk inhibitor) Osaka, Japan www.ono.co.jp
OPB-111077 Otsuka Pharmaceutical solid tumors Phase I
(signal transduction pathway inhibitor) Rockville, MD www.otsuka.com
Medicines in Development: Cancer ǀ 2018 211
Solid TumorsProduct Name Sponsor Indication Development Phase
Opdivo® Bristol-Myers Squibb virus positive/negative solid tumors Phase I/II
nivolumab Princeton, NJ www.bms.com
Opdivo® + Yervoy® Bristol-Myers Squibb virus positive/negative solid tumors Phase I/II
nivolumab + ipilimumab Princeton, NJ www.bms.com
Oradoxel Athenex solid tumors Phase I
docetaxel oral Buffalo, NY www.athenex.com
oral-Vimo-001 Veana Therapeutics solid tumors Phase I
(alpha-tocopheroloxyacetic acid) Portland, OR www.veana-therapeutics.com
Oratecan™ Athenex advanced solid tumors Phase I
irinotecan+HM30181A Buffalo, NY www.athenex.com
Hamni Pharmaceutical
Seoul, South Korea
pamiparib (BGB-290) BeiGene USA solid tumors Phase I/II(PARP inhibitor) Cambridge, MA www.beigene.com
PCM-075 TrovaGene advanced solid tumors Phase I(PLK1 inhibitor) San Diego, CA www.trovagene.com
PD-L1 mAb + LY combo Eli Lilly solid tumors Phase I
Indianapolis, IN www.lilly.com
Medicines in Development: Cancer ǀ 2018 212
Solid TumorsProduct Name Sponsor Indication Development Phase
pegargiminase Polaris Pharmaceuticals advanced solid tumors Phase I(ADI-PEG-20) San Diego, CA (+pembrolizumab) www.polarispharma.com
PEN-866 Tarveda Therapeutics solid tumors Phase I/II(DNA topoisomerase I inhibitor) Watertown, MA www.tarveda.com
PF-06804103 Pfizer solid tumors Phase I(antibody-drug conjugate) New York, NY www.pfizer.com
PIN-2 PIN Pharma solid tumors Phase I
(Immune modulator) New York, NY www.pinpharma.com
PLX51107 Plexxikon solid tumors Phase I(BET inhibitor) Berkeley, CA www.plexxikon.com
PLX73086 Plexxikon solid tumors Phase I(CSR-1R antagonist) Berkeley, CA www.plexxikon.com
PLX7486 Plexxikon solid tumors Phase I(Fms/TRK inhibitor) Berkeley, CA www.plexxikin.com
PLX8394 Plexxikon BRAF-mutant solid tumors Phase II(BRAF inhibitor) Berkeley, CA www.plexxikon.com
PLX9486 Plexxikon KIT-mutant solid tumors Phase I(c-kit inhibitor) Berkeley, CA www.plexxikon.com
Poly-ICLC Oncovir solid tumors Phase II(biological response modifier) Washington, DC www.oncovir.com
Medicines in Development: Cancer ǀ 2018 213
Solid TumorsProduct Name Sponsor Indication Development Phase
PRN1371 Principia Biopharma solid tumors Phase I
(FGFR inhibitor) South San Francisco, CA www.principiabio.com
PRS-343 Pieris Pharmaceuticals solid tumors Phase I
(HER2/41BB bispecific mAb) Boston, MA www.pieris.com
PT-112 Phosplatin Therapeutics advanced solid tumors Phase I
phosphaplatin New York, NY www.phosplatin.com
PT2977 Peloton Therapeutics advanced solid tumors Phase I
(HIF-2α inhibitor) Dallas, TX www.pelotontherapeutics.com
PTX-100 Prescient Therapeutics solid tumors Phase I completed
(geranylgeranyl transferase inhibitor) South Melbourne, Australia www.ptxtherapeutics.com
pyrotinib Hengrui Therapeutics HER2-postive solid tumors Phase I
(EGFR/ErbB2 kinase inhibitor) Princeton, NJ www.hengruitherapeutics.com
relacorilant Corcept Therapeutics solid tumors (+nab-paclitaxel), Phase I/II
(glucocorticoid receptor II antagonist) Menlo Park, CA www.corcept.com
relatlimab Bristol-Myers Squibb solid tumors (+/-nivolumab) Phase I/II
(anti-LAG3 mAb) Princeton, NJ www.bms.com
RG6146 Roche/Genentech solid tumors Phase I
(BET inhibitor) South San Francisco, CA www.roche.com
Medicines in Development: Cancer ǀ 2018 214
Solid TumorsProduct Name Sponsor Indication Development Phase
RG7386 Roche/Genentech solid tumors Phase I
(FAP-DR5 bispecific mAb) South San Francisco, CA www.roche.com
RG7461 Roche/Genentech solid tumors Phase I
(IL-1 variant fused to FAP antagonist) South San Francisco, CA www.roche.com
RG7802 Roche/Genentech solid tumors (+atezolizumab) Phase I
(CEA T-cell bispecific mAb) South San Francisco, CA www.roche.com
RG7813 Roche/Genentech solid tumors (+atezolizumab) Phase I
(cergutuzumab amunaleukin) South San Francisco, CA www.roche.com
RGX-104 Rgenix solid tumors Phase I
(LXR agonist) New York, NY www.rgenix.com
rivoceranib LSK Biopharma solid tumors (+nivolumab) Phase I
(VEGFr-2 antagonist) Salt Lake City, UT www.lskbiopharma.com
rogaratinib Bayer Pharmaceuticals solid tumors Phase I
(pan-EGFR inhibitor) Whippany, NJ www.pharma.bayer.com
rosmantuzumab OncoMed Pharmaceuticals solid tumors Phase I
(RSPO3 protein inhibitor) Redwood City, CA www.oncomed.com
RP1 Replimmune solid tumors Phase I/II
(oncolytic virus immunotherapy) Woburn, MA www.replimmune.com
Medicines in Development: Cancer ǀ 2018 215
Solid TumorsProduct Name Sponsor Indication Development Phase
RRx-001 EpicentRx advanced or metastatic solid tumors Phase I
(free radical stimulant) La Jolla, CA www.epicentrx.com
rSIFN-co Sichuan Huiyang solid tumors Phase I
(interferon) Chengdu City, China
RXDX-105 Ignyta solid tumors Phase I
(VEGFR-sparing RET inhibitor) San Diego, CA www.ignyta.com
SAR408701 Sanofi solid tumors Phase I
(maytansin-loaded anti-CEACAM5 mAb) Bridgewater, NJ www.sanofi.com
SAR439459 Sanofi advanced solid tumors Phase I
(anti-TGF-beta mAb) Bridgewater, NJ www.sanofi.com
SAR439859 Sanofi advanced solid tumors (+cemiplimab) Phase I
(SERD) Bridgewater, NJ www.sanofi.com
SC-004 AbbVie solid tumors Phase I
(antibody-drug conjugate) North Chicago, IL www.abbvie.om
SDX-7320 SynDevRx solid tumors Phase I
(MetAP2 inhibitor) Cambridge, MA www.syndevrx.com
SEA-CD40 Seattle Genetics solid tumors (+/-checkpoint inhibitor) Phase I
(anti-CD40 mAb) Bothell, WA www.seattlegenetics.com
Medicines in Development: Cancer ǀ 2018 216
Solid TumorsProduct Name Sponsor Indication Development Phase
selicrelumab Roche/Genentech solid tumors (combination therapy) Phase I
(anti-CD40 mAb) South San Francisco, CA www.roche.com
sEphB4-HSA VasGene Therapeutics solid tumors Phase I
(recombinant fusion protein) Los Angeles, CA
Seprehvir® Sorrento Therapeutics solid tumors Phase I
oncolytic virus immunotherapy San Diego, CA www.sorrentotherapeutics.com
SGN-2FF Seattle Genetics advanced solid tumors Phase I
(fucosylation inhibitor) Bothell, WA www.seattlegenetics.com
SGT-53 SynerGene Therapeutics solid tumors (pediatric) Phase I
(gene therapy) Rockville, MD
sitravatinib (MGCD516) Mirati Therapeutics advanced solid tumors Phase I/II
(multi kinase inhibitor) San Diego, CA www.mirati.com
SL-801 Stemline Therapeutics advanced solid tumors Phase I
(XPO1 inhibitor) New York, NY www.stemline.com
SM08502 Samumed solid tumors Phase I
(Wnt signaling pathway inhibitor) San Diego, CA www.samumed.com
SNDX-6352 Syndax Pharmaceuticals solid tumors Phase I
(CSF-1R antagonist) Waltham, MA www.syndax.com
Medicines in Development: Cancer ǀ 2018 217
Solid TumorsProduct Name Sponsor Indication Development Phase
SOR-C13 Soricimed Biopharma solid tumors Phase I
(TRPV6 protein inhibitor) Moncton, Canada www.soricimed.com
SRF231 Surface Oncology solid tumors Phase I
(anti-CD47 mAb) Cambridge, MA www.surfaceoncology.com
sulfatinib Hutchison MediPharma advanced solid tumors Phase I
(VEGFR/FGFR-1/CSF1R inhibitor) Shanghai, China www.hmplglobal.com
SY-1365 Syros Pharmaceuticals solid tumors Phase I
(CDK7 inhibitor) Cambridge, MA www.syros.com
Sym015 Symphogen met-amplified advanced solid tumors Phase I/II
(MET inhibitor) Somerville, NJ www.symphogen.com
Sym021 Symphogen solid tumors Phase I
(anti-PD-1 mAb) Somerville, NJ www.symphogen.com
SYN004 Synermore Biologics solid tumors Phase I
(anti-EGFR mAb) Taipei City, Taiwan www.synermore.com
Taclantis™ Sun Pharma Advanced Research solid tumors Phase IIpaclitaxel liposomal Mumbai, India www.sparc.life
TAK-202 Takeda Oncology solid tumors Phase I
(CCR2 antagonist) Deerfield, IL www.takeda.com
Medicines in Development: Cancer ǀ 2018 218
Solid TumorsProduct Name Sponsor Indication Development Phase
TAK-243 Takeda Oncology solid tumors Phase I
(ubiquitin-activating enzyme Deerfield, IL www.takeda.com
inhibitor)
TAK-580 Takeda Oncology solid tumors Phase II
(Pan-Raf kinase inhibitor) Deerfield, IL www.takeda.com
TAK-931 Takeda Oncology solid tumors Phase I
(CDC7 inhibitor) Deerfield, IL www.takeda.com
TAS-116 Taiho Oncology solid tumors Phase I
(HSP90 inhibitor) Princeton, NJ www.taihooncology.com
TAS-119 Taiho Oncology advanced solid tumors Phase I
(aurora kinase A inhibitor) Princeton, NJ www.taihooncology.com
TAS-120 Taiho Oncology advanced solid tumors Phase I/II
(FGF/FGFR inhibitor) Princeton, NJ www.taihooncology.com
tavolimab (MEDI0562) MedImmune solid tumors Phase I
(OX40 agonist) Gaithersburg, MD www.medimmune.com
tazemetostat Epizyme INI1-negative solid tumors Phase II
(EZH2 enzyme inhibitor) Cambridge, MA www.epizyme.com
advanced solid tumors Phase I/II
www.epizyme.com
Medicines in Development: Cancer ǀ 2018 219
Solid TumorsProduct Name Sponsor Indication Development Phase
Tecentriq® Genentech solid tumors (monotherapy), Phase I
atezolizumab South San Francisco, CA solid tumors (Morpheus platform), www.gene.com
solid tumors (+cobimetinib),
solid tumors (+ipi/IFN)
telisotuzumab vedotin (ABBV-399) AbbVie solid tumors Phase I
(antibody-drug conjugate) North Chicago, IL www.abbvie.com
TEW-7197 MedPacto advanced solid tumors Phase I
(TGF-beta antagonist) Suwon, South Korea www.medpacto.com
TI-061 Arch Oncology solid tumors Phase I/II
(anti-CD47 mAb) San Francisco, CA www.archoncology.com
tilsotolimod (IMO-2125) Idera Pharmaceuticals refractory solid tumors Phase I
(TLR9 agonist) Cambridge, MA www.iderapharma.com
tinostamustine (EDO-S101) Mundipharma advanced solid tumors Phase I/II
(histone deacetylase inhibitor) Cambridge, United Kingdom www.mundipharma.com
tisotumab vedotin Genmab solid tumors Phase II
(tissue factor antibody-drug conjugate) Princeton, NJ www.seattlegenetics.com
Seattle Genetics
Bothell, WA
TLC178 Taiwan Liposome Company advanced solid tumors Phase I/II
(vinorelbine liposomal) Taipei, Taiwan www.tlcbio.com
Medicines in Development: Cancer ǀ 2018 220
Solid TumorsProduct Name Sponsor Indication Development Phase
TNO155 Novartis Oncology solid tumors Phase I
(SHP2 inhibitor) East Hanover, NJ www.novartis.com
Toca 511 + Toca Fc Tocagen solid tumors Phase I
(vocimagene amiretrorepvec- San Diego, CA www.tocagen.com
flucytosine gene therapy)
TP-0903 Tolero Pharmaceuticals solid tumors Phase I
(Axl kinase inhibitor) Lehi, UT www.toleropharma.com
TPX-0005 (ropotrectinib) TP Therapeutics solid tumors Phase I/II
(ALK/ROS-1/TRK inhibitor) San Diego, CA www.tptherapeutics.com
tractinostat Viracta Therapeutics EBV-positive solid tumors Phase I
(HDAC inhibitor) Cardiff, CA (+valganciclovir) www.viracta.com
TRC-102 TRACON Pharmaceuticals solid tumors Phase I
(methoxyamine hydrochloride) San Diego, CA www.traconpharma.com
tremelimumab MedImmune solid tumors (+MEDI0562) Phase I
(IgG2 monoclonal antibody) Gaithersburg, MD www.medimmune.com
TRK-950 Apexigen solid tumors Phase I
(mAb) San Carlos, CA www.apexigen.com
Toray
Tokyo, Japan
Medicines in Development: Cancer ǀ 2018 221
Solid TumorsProduct Name Sponsor Indication Development Phase
TRX518 Leap Therapeutics solid tumors (+anti-PD-1), Phase I/II
(GITR agonist antibody) Cambridge, MA solid tumors (+chemotherapy) www.leaptx.com
solid tumors (monotherapy) Phase I
www.leaptx.com
TRX-818 (CVM-1118) TaiRx solid tumors Phase I
(angiogenesis inhibitor) Taipei, Taiwan www.tairx.tw
TSR-022 TESARO solid tumors Phase I
(anti-TIM-3 mAb) Waltham, MA www.tesarobio.com
TSR-033 TESARO solid tumors Phase I
(anti-LAG3 mAb) Waltham, MA www.tesarobio.com
TSR-042 TESARO solid tumors Phase I
(anti-PD-1 mAb) Waltham, MA www.tesarobio.com
TTI-621 Trillium Therapeutics solid tumors Phase I
(CD47 inhibitors/SIRPA stimulant) Mississauga, Canada www.trilliumtherapeutics.com
urelumab Bristol-Myers Squibb advanced solid tumors (+nivolumab) Phase I/II
(anti-CD137 mAb) Princeton, NJ www.bms.com
USL311 Upsher-Smith solid tumors Phase I/II
(CXCR4 antagonist) Maple Grove, MN www.upsher-smith.com
Medicines in Development: Cancer ǀ 2018 222
Solid TumorsProduct Name Sponsor Indication Development Phase
Vigil™ Gradalis solid tumors (+PD-1/PD-L1) Phase II
autologous tumor cell vaccine Carrolton, TX www.gradalisinc.com
vistusertib AstraZeneca solid tumors Phase II
(mTORC1/2 inhibitor) Wilmington, DE www.astrazeneca.com
VLX600 Vivolux solid tumors Phase I
(iron chelator) Uppsala, Sweden www.vivolux.com
vorolanib (X-82) Tyrogenex advanced solid tumors Phase I completed
(VEGFR and PDGFR inhibitor) Rockville, MD
VSV-IFN-beta-NIS Vyriad solid tumors Phase I
Rochester, NY www.vyriad.com
VT1021 Vigeo Therapeutics solid tumors Phase I
(peptide immunomodulator) Cambridge, MA www.vigeotherapeutics.com
WT-2725 Sunovion Pharmaceuticals solid tumors Phase I
(peptide cancer vaccine) Marlborough, MA www.sunovion.com
X4P-001-IO X4 Pharmaceuticals solid tumors Phase I/II
(CXCR4 inhibitor) Cambridge, MA www.x4pharma.com
XMT-1536 Mersana Therapeutics NaPi2b-expressing solid tumors Phase I
(anti-NaPi2b immunoconjugate) Cambridge, MA www.mersana.com
Medicines in Development: Cancer ǀ 2018 223
OtherProduct Name Sponsor Indication Development Phase
abexinostat Xynomic Pharmaceuticals gynecologic cancer Phase II
(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com
ABI-009 AADi Bioscience malignant perivascular Phase II
(nab-rapamycin/mTOR inhibitor) Los Angeles, CA epithelioid cell tumors www.aadibio.com
ADXS-DUAL Advaxis metastatic cervical cancer Phase III
(cancer immunotherapy vaccine) Princeton, NJ (+nivolumab) www.advaxis.com
AGEN1884 Agenus cervical cancer (+AGEN2034) Phase I/II
(CTLA-4 antagonist) Lexington, MA www.agenus.com
aglatimagene besadenovec Advantagene malignant pleural effusion Phase I
(gene therapy) Auburndale, MA www.advantagene.com
AL3818 Advenchen Laboratories cervical cancer, endometrial cancer, Phase I/II
(tyrosine kinase inhibitor) Moorpark, CA fallopian tube cancer, primary www.advenchen.com
peritoneal cancer
AQST-305 Aquestive Therapeutics malignant carcinoid syndrome Phase I
(octreotide oral film) Warren, NJ www.aquestive.com
AU-011 Aura Biosciences uveal melanoma (Fast Track) Phase I/II
(light-activated viral nanoparticles) Cambridge, MA www.aurabiosciences.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 224
OtherProduct Name Sponsor Indication Development Phase
axalimogene filolisbac (AXAL) Advaxis high-risk locally advanced cervical Phase III
(cancer immunotherapy vaccine) Princeton, NJ cancer (Fast Track) www.advaxis.com
ORPHAN DRUG
metastatic anal cancer, Phase II
metastatic cervical cancer www.advaxis.com
(+durvalumab)
Azedra® Progenics Pharmaceuticals malignant and/or recurrent application submitted
Ultratrace® iobenguane I-131 New York, NY pheochromocytoma and paraganglioma www.progenics.com
ORPHAN DRUG (Fast Track)
BMS-986277 Bristol-Myers Squibb epithelial cancer Phase I/II
Princeton, NJ www.bms.com
Cabometyx™ Exelixis carcinoid tumors, Phase II
cabozantinib South San Francisco, CA endometrial cancer (+nivolumab) www.exelixis.com
genitourinary tumors Phase I
(+nivolumab +/-ipilimumab) www.exelixis.com
CBT-1 CBA Pharma cancer with multiple drug resistance application submitted
(tetrandrine) Lexington, KY (adjunctive therapy) www.cbapharma.com
Medicines in Development: Cancer ǀ 2018 225
OtherProduct Name Sponsor Indication Development Phase
cemiplimab Regeneron Pharmaceuticals squamous cell carcinoma application submitted
(anti-PD-1 mAb) Tarrytown, NY (Breakthrough Therapy) www.sanofi.com
Sanofi
Bridgewater, NJ
2L cervical cancer Phase III
www.sanofi.com
CLR-131 Cellectar Biosciences pediatric cancer Phase I
(phospholipid-drug conjugate) Madison, WI www.cellectar.com
COTI-2 Cotinga Pharmaceuticals cervical cancer, endometrial cancer, Phase I
(p53 gene modulator) London, Canada fallopian tube cancer, peritoneal www.cotingapharma.com
cancer
CPP-1X Cancer Prevention Pharmaceuticals neuroblastoma Phase II
(eflornithine + high dose powder sachet) Tucson, AZ www.canprevent.com
ORPHAN DRUG
DCC-2618 Deciphera Pharmaceuticals advanced systemic mastocytosis Phase I
(PDGFR-alpha kinase switch Waltham, MA www.deciphera.com
control inhibitor)
DKN-01 Leap Therapeutics relapsed/refractory endometroid Phase II
(anti-DKK1 mAb) Cambridge, MA endometrial cancer www.leaptx.com
DP-1038 Dauntless Pharmaceuticals neuroendocrine tumors Phase I
(intranasal octreotide) San Diego, CA www.dauntlessph.com
Medicines in Development: Cancer ǀ 2018 226
OtherProduct Name Sponsor Indication Development Phase
DPX-E7 Immunovaccine HPV-related anal cancer, Phase I/II
(peptide cancer vaccine) Halifax, Canada HPV-related cervical cancer www.imvaccine.com
DPX-Survivac Immunovaccine advanced fallopian cancer (Fast Track), Phase I
(cancer vaccine) Halifax, Canada advanced peritoneal cacner (Fast Track) www.imvaccine.com
E7046 Adlai Nortye rectal cancer Phase I
(EP4 antagonist) Hangzhou, China www.adlainortye.com
erdafitinib Janssen Research & Development urogenital cancer Phase II
(FGFRI kinase inhibitor) Raritan, NJ www.janssen.com
fimepinostat (CUDC-907) Curis neuroblastoma Phase I
(HDAC/PI3K inhibitor) Lexington, MA www.curis.com
Gilotrif® Boehringer Ingelheim Pharmaceuticals neuroectodermal tumors Phase I/II
afatinib Ridgefield, CT www.boehringer-ingelheim.com
ORPHAN DRUG
GL-ONC1 Genelux peritoneal cavity cancer Phase I
(oncolytic virus therapy) San Diego, CA www.genelux.com
IMCgp100 Immunocore uveal melanoma Phase II
(T-cell receptor therapy) Conshohocken, PA www.immunocore.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 227
OtherProduct Name Sponsor Indication Development Phase
ingenol disoxate LEO Pharma squamous cell carcinoma (prevention) Phase III
(protein kinase C stimulant) Madison, NJ www.leo-pharma.us
iobenguane-I-131 Jubilant DraxImage neuroblastoma Phase II
Kirkland, Canada www.draximage.com
New Approaches to Neuroblastoma
Therapy Consortium
Los Angeles, CA
IPI-549 Infinity Pharmaceuticals adrenocortical carcinoma (+nivolumab) Phase I
(PI3K-gamma inhibitor) Cambridge, MA www.infi.com
Keytruda® Merck nasopharyngeal cancer Phase III
pembrolizumab Kenilworth, NJ www.merck.com
larotrectinib (LOXO-101) Loxo Oncology locally advanced or metastatic solid application submitted
(TRK inhibior) Stamford, CT tumors harboring an NTRK gene fusion www.loxooncology.com
ORPHAN DRUG (Breakthrough Therapy)
solid or primary CNS tumors with Phase II
TRK infusions (adults) www.loxooncology.com
solid or primary CNS tumors with Phase I/II
TRK infusions (pediatric) www.loxooncology.com
LN-145 Iovance Biotherapeutics cervical cancer Phase II
(tumor-infiltrating lymphocyte) San Carlos, CA www.iovance.com
Medicines in Development: Cancer ǀ 2018 228
OtherProduct Name Sponsor Indication Development Phase
lurbinectedin (PM1183) PharmaMar 2L endometrial cancer Phase II
(RNA polymerase II inhibitor) Madrid, Spain www.pharmamar.com
LXS196 Novartis Oncology uveal melanoma Phase I
(protein kinase C inhibitor) East Hanover, NJ www.novartis.com
MCS110 Novartis Oncology giant cell tumor of the tendon sheath Phase II
(CSF-1 mAb) East Hanover, NJ www.novartis.com
mirvetuximab soravtansine ImmunoGen FOLR1-positive endometrial cancer Phase I
(folate receptor 1 antagonist) Waltham, MA www.immunogen.com
navicixizumab OncoMed Pharmaceuticals fallopian tube cancer, Phase I
(anti-DLL4/VEGF bispecific mAb) Redwood City, CA peritoneal cancer www.oncomed.com
naxitamab Y-mAbs Therapeutics relapsed/refractory neuroblastoma Phase III
(anti-GD2 3F8 mAb) New York, NY www.ymabs.com
ORPHAN DRUG
nirogacestat SpringWorks Therapeutics desmoid tumor Phase II
(gamma secretase inhibitor) New York, NY www.springworkstx.com
omburtamab I-131 Y-mAbs Therapeutics CNS/leptomeningeal metastasis Phase II/III
(B7-H3 inhibitor) New York, NY from neuroblastoma www.ymabs.com
ORPHAN DRUG
desmoplastic small round cell tumor Phase I/II
www.ymabs.com
Medicines in Development: Cancer ǀ 2018 229
OtherProduct Name Sponsor Indication Development Phase
ONC201 Oncoceutics endometrial cancer, Phase II
(dopamine receptor D2/3 antagonist) Philadelphia, PA neuroendocrine tumors www.oncoceutics.com
ovapuldencel-T AiVita Biomedical advanced peritoneal cancer Phase II
(dendritic cell cancer vaccine) Irvine, CA advanced fallopian tube cancer www.aivitabiomedical.com
p53 cell pentrating peptide CDG Therapeutics recurrent or progressive CNS tumors Phase I completed
Chicago, IL www.cdgti.com
patidegib PellePharm basal cell nevus syndrome Phase II
(hedgehog signaling inhibitor) San Francisco, CA (Gorlin Syndrome) www.pellepharm.com
ORPHAN DRUG
pegargiminase Polaris Pharmaceuticals ASS1-deficient tumors Phase I
(ADI-PEG-20) San Diego, CA (+pemetrexed +cisplatin) www.polarispharma.com
PEGPH20 Halozyme Therapeutics gallbladder adenocarcinoma Phase I
(pegylated recombinant San Diego, CA (+atezolizumab) www.halozyme.com
human hyalurinodase)
PEN-221 Tarveda Therapeutics neuroendocrine tumors Phase I/II
(somatostatin receptor 2 modulator) Watertown, MA www.tarveda.com
Pixuvri® CTI BioPharma relapsed/refractory cancer (pediatric) Phase I
pixantrone Seattle, WA www.ctibiopharma.com
Medicines in Development: Cancer ǀ 2018 230
OtherProduct Name Sponsor Indication Development Phase
Prolanta™ Oncolix fallopian tube cancer, Phase I
prolactin receptor antagonist Houston, TX peritoneal cancer www.oncolixbio.com
PTC596 PTC Therapeutics fallopian tube cancer, Phase I
(tumor stem cell targeting) South Plainfield, NJ peritoneal cancer www.ptcbio.com
PV-10 Provectus Biopharmaceuticals neuroendocrine tumors Phase I
(rose bengal sodium) Knoxville, TN www.provectusbio.com
REM-001 (rostaporfin) Adgero Biopharmaceuticals cutaneous metastatic recurrent Phase I
(photosensitizer) Princeton, NJ basal cell nevus syndrome www.adgerobiopharm.com
ORPHAN DRUG
Rova-T AbbVie neuroendocrine tumors Phase I
(rovalpituzumab tesirine) North Chicago, IL www.abbvie.com
RRx-001 EpicentRx neuroendocrine tumors Phase II
(free radical stimulant) La Jolla, CA www.epicentrx.com
sacituzumab govitecan Immunomedics metastatic endometrial can cer Phase II
(anti-TROP-2-SN-38 ADC) Morris Plains, NJ www.immunomedics.com
selinexor Karyopharm Therapeutics endometrial cancer Phase III
(nuclear export inhibitor) Newton, MA www.karyopharm.com
Medicines in Development: Cancer ǀ 2018 231
OtherProduct Name Sponsor Indication Development Phase
selumetinib AstraZeneca differentiated thyroid cancer Phase III
(MEK1/2 inhibitor) Wilmington, DE www.astrazeneca.com
ORPHAN DRUG Merck www.merck.com
Kenilworth, NJ
SNX-5422 Esanex neuroendocrine tumors Phase I
(Hsp90 inhibitor) Indianapolis, IN www.esanexpharma.com
Sym013 Symphogen advanced epithelial cancer Phase I/II
(EGFR/HER2/HER3 inhibitor) Somerville, NJ www.symphogen.com
tirabrutinib Gilead Sciences B-cell malignancies Phase II
(Btk inhibitor) Foster City, CA www.gilead.com
TT12 (armoured HPVST) Tessa Therapeutics cervical cancer Phase I
(HPV-specific T-cell therapy) Singapore www.tessatherapeutics.com
VGX-3100 Inovio Pharmaceuticals cervical high-grade squamous Phase III
(DNA cancer vaccine) Plymouth meeting, PA intraepithelial lesions www.inovio.com
vulvar high-grade squamous Phase II
intraepithelial lesions www.inovio.com
XBIO-101 Xenetic Biosciences recurrent or persistent endometrial Phase II
(cridanimod) Lexington, MA cancer www.xeneticbio.com
ORPHAN DRUG
Medicines in Development: Cancer ǀ 2018 232
OtherProduct Name Sponsor Indication Development Phase
XmAb18087 Xencor neuroendocrine tumors Phase I
(SSTR2 x CD3 bispecific mAb) Monrovia, CA www.xencor.com
Xofigo® Bayer Pharmaceuticals bone metastases in breast cancer Phase II
radium Ra 223 dichloride Whippany, NJ www.pharma.bayer.com
UnspecifiedProduct Name Sponsor Indication Development Phase
AB122 Arcus Biosciences cancer Phase I
(anti-PD-1 mAb) Hayward, CA www.arcusbio.com
AB928 Arcus Biosciences cancer Phase I
(adenosine A2A/A2B Hayward, CA www.arcusbio.com
receptor antagonist)
AK107 Akeso Biopharma cancer Phase I
(checkpoint inhibitor) Guangdong, China www.akesobio.com
Merck
Kenilworth, NJ
anti-PD-L1 mAb TG Therapeutics cancer Phase I
New York, NY www.tgtherapeutics.com
autologous stem cell-based StemImmune cancer Phase I completed
cancer immunotherapy San Diego, CA www.stemimmune.com
Medicines in Development: Cancer ǀ 2018 233
UnspecifiedProduct Name Sponsor Indication Development Phase
AutoSynVax® Agenus advanced cancer Phase I
autologous synthetic vaccine Lexington, MA www.agenusbio.com
Bavencio® EMD Serono cancer (+OX40 +4-1BB) Phase I
avelumab Rockland, MA www.emdserono.com
(anti-PD-L1 inhibitor) Pfizer www.pfizer.com
New York, NY
bevacizumab biosimilar Apobiologix cancer in clinical trials
Weston, FL www.apobiologix.com
BMS-986205 Bristol-Myers Squibb advanced cancer (+nivolumab) Phase I
(IDO1 inhibitor) Princeton, NJ www.bms.com
BPX-501 Bellicum Pharmaceuticals cancer (adults) Phase I/II
(rivogenlecleucel) Houston, TX www.bellicum.com
cemiplimab Regeneron Pharmaceuticals advanced cancer (+REGN3767) Phase I
(anti-PD-1 mAb) Tarrytown, NY www.sanofi.com
Sanofi
Bridgewater, NJ
CPI-006 Corvus Pharmaceuticals advanced cancer Phase I
(type 2 humanized IgG1 antibody) Burlingame, CA (+/-CPI-444 +/-pembrolizumab) www.corvuspharma.com
CPI-444 Corvus Pharmaceuticals advanced cancer (+/-atezolizumab) Phase I
(adenosine A2A receptor antagonist) Burlingame, CA www.corvuspharma.com
Medicines in Development: Cancer ǀ 2018 234
UnspecifiedProduct Name Sponsor Indication Development Phase
dendritic cancer vaccine ImmunoRestoration cancer Phase I/II completed
Warminster, PA www.immunorestoration.com
FS118 F-star Biotechnology advanced malignancies Phase I
(anti-LAG-3/anti-PD-L1) Cambridge, United Kingdom www.f-star.com
bispecific antibody)
gedatolisib (PF-05212384) Pfizer cancer Phase I
(PI3K/mTOR inhibitor) New York, NY www.pfizer.com
glasdegib Pfizer cancer Phase I
(SMO antagonist) New York, NY www.pfizer.com
human microbiome modulator Kaleido Biosciences cancer Phase I
Bedford, MA www.kaleido.com
Ibrance® Pfizer cancer Phase I
palbociclib New York, NY www.pfizer.com
IDH305 Novartis Oncology advanced malignancies with Phase I
(IDH1 inhibitor) East Hanover, NJ IDH1R132 mutations www.novartis.com
INCB53914 Incyte advanced malignancies Phase I/II
(pan-PIM kinase inhibitor) Wilmington, DE www.incyte.com
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UnspecifiedProduct Name Sponsor Indication Development Phase
INCB57643 Incyte advanced malignancies Phase I/II
(bromodomain inhibitor) Wilmington, DE www.incyte.com
Inlyta® Pfizer cancer (+pembrolizumab) Phase I
axitinib New York, NY www.pfizer.com
IRX5183 Io Therapeutics cancer Phase I
(RXR agonist) Santa Ana, CA www.io-therapeutics.com
LOXO-195 Bayer Pharmaceuticals cancer Phase I
(TRK inhibitor) Whippany, NJ www.pharma.bayer.com
Loxo Oncology www.loxooncology.com
Stamford, CT
MCS110 Novartis Oncology advanced malignancies (+PDR001) Phase I/II
(CSF-1 mAb) East Hanover, NJ www.novartis.com
napabucasin Boston Biomedical advanced malignancies (+ paclitaxel) Phase I/II
(STAT3 inhibitor) Cambridge, MA www.bostonbiomedical.com
ORB-101 Orbis Biosciences cancer Phase I
(prednisone microencapsulated) Lenexa, KS www.orbisbio.com
ORIC-101 ORIC Pharmaceuticals cancer Phase I
(glucocorticoid receptor antagonist) South San Francisco, CA www.oricpharma.com
Medicines in Development: Cancer ǀ 2018 236
UnspecifiedProduct Name Sponsor Indication Development Phase
PAC-1 (VO-100) Vanquish Oncology advanced malignancies Phase I
(procaspase activating compound-1) Campaign, IL www.vanquishoncology.com
PF-04518600 Pfizer cancer Phase I
(OX40 receptor agonist) New York, NY www.pfizer.com
PF-06647020 (cofetuzumab pelidotin) Pfizer cancer Phase I
(PTK7 targeted cytotoxicity) New York, NY www.pfizer.com
PF-06671008 Pfizer cancer Phase I
(anti-CD3/P-cadherin bispecific New York, NY www.pfizer.com
antibody)
PF-06688992 Pfizer cancer Phase I
(antibody-drug conjugate) New York, NY www.pfizer.com
PF-06747775 (mavelertinib) Pfizer cancer Phase I
(epidermal growth factor receptor) New York, NY www.pfizer.com
PF-06801591 Pfizer cancer Phase I
(PD-1 antagonist immunotherapy) New York, NY www.pfizer.com
PLX2853 Plexxikon cancer Phase I
(BRD4 inhibitor) Berkeley, CA www.plexxikon.com
Medicines in Development: Cancer ǀ 2018 237
UnspecifiedProduct Name Sponsor Indication Development Phase
REGN1979 Regeneron Pharmaceuticals cancer (+cemiplimab) Phase I
(anti-CD20/CD3 bispecific mAb) Tarrytown, NY www.regeneron.com
REGN3767 Regeneron Pharmaceuticals advanced cancer Phase I
(anti-LAG-3 mab) Tarrytown, NY www.regeneron.com
Sanofi www.sanofi.com
Bridgewater, NJ
RG6180 Genentech cancer Phase I
(personalized cancer vaccine) South San Francisco, CA www.gene.com
rituximab biosimilar Apobiologix cancer in clinical trials
Weston, FL www.apobiologix.com
TAB001 Shanghai Junshi Biosciences advanced malignancies Phase I
(anti-PD-1 mAb) Shanghai, China www.junshipharma.com
TSR-042 TESARO advanced or metastatic Phase I
(anti-PD-1 mAb) Waltham, MA (combination therapy) www.tesarobio.com
veltuzumab Immunomedics cancer Phase II completed
(anti-CD20 mAb) Morris Plains, NJ www.immunomedics.com
Medicines in Development: Cancer ǀ 2018 238
The content of this report has been obtained through public, government and industry sources, and the Springer "Adis Insight” database based on the latest
information. Report current as of May 6, 2018. The medicines in this listing include medicines being developed by U.S.-based companies conducting trials
in the United States abroad, PhRMA-member companies conducting trials in the United States and abroad, and foreign companies conducting clinical trials in
the United States. Some products may not be in active clinical trials. The information may not be comprehensive. For more, specific information about a particular
product, contact the individual company directly or go to www.clinicaltrials.gov. The entire series of Medicines in Development is available on PhRMA's
website: www.phrma.org.
Definitions
Application Submitted—An application for marketing has been submitted by the company to the U.S. Food and Drug Administration (FDA).
Breakthrough Therapy—Upon request by a sponsor, the FDA can grant this designation to expedite the development and review of a drug or biologic intended, alone
or in combination with one or more other drugs, to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that it may
demonstrate substantial improvement over existing therapies on one or more clinically-significant endpoints, such as substantial treatment effects observed early in
clinical development. If a drug or biologic is designated as a Breakthrough Therapy, the FDA will expedite the development and review. With this designation, all Fast
Track features convey to the medicine.
Fast Track—Upon request by a sponsor, the FDA can grant this designation to facilitate the development and expedite the review of a drug or biologic to treat a
serious condition and fill an unmet medical need. When considering a biopharmaceutical company’s request for Fast Track designation for an investigational
drug or biologic, the FDA evaluates whether it will affect factors such as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will
progress from a less severe condition to a more serious one, and whether a condition can be adequately addressed by available therapy. With Fast Track designation,
early and frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review
process to help to quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.
Orphan Designation—Upon request by a sponsor, the FDA can grant special status (“orphan status”) to a drug or biologic to treat a rare disease or condition.
In order to receive an orphan designation, a qualifying drug or biologic must be intended for the treatment, diagnosis, or prevention of a rare disease or
condition that affects usually fewer than 200,000 people in the United States.
Phase I—Researchers test the investigational drug or biologic in a small group of people, usually between 20 and 100 healthy adult volunteers, to evaluate
its initial safety and tolerability profile, determine a safe dosage range, and identify potential side effects.
Phase II—The investigational drug or biologic is given to volunteer patients, usually between 100 and 500, to determine whether it is effective, identify an
optimal dose, and to further evaluate its short-term safety.
Phase III—The investigational drug or biologic is given to a larger, more diverse patient population, often involving between 1,000 and 5,000 patients
(but sometimes many more), to generate statistically significant evidence to confirm its safety and effectiveness. Phase III studies are the longest studies
and usually take place in multiple sites around the world.
Medicines in Development: Cancer ǀ 2018 239