Development therapeutics in 2018€¦ · Monday, June 19th, 2017 . Outline ... SNAPshot NGS...
Transcript of Development therapeutics in 2018€¦ · Monday, June 19th, 2017 . Outline ... SNAPshot NGS...
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Development therapeutics
in 2018
Christophe MASSARD, MD PhD
U 981
CLUB Phase 1, 23 NOV 2017
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• Participation to advisory boards, speaker or investigator for: Amgen, Astellas, Astra Zeneca, Bayer, Celgene, Genentech, Ipsen, Jansen, Lilly, Novartis, Pfizer, Roche, Sanofi, Orion, MedImmune, New Oncology, DebioPharm
• I am a PI of Eli Lilly and Company trial with NOTCH inhibitor
• I will not discuss off label use in my presentation
• I will discuss investigational use in my presentation
Disclosure
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• I am a medical oncologist
• I am a Phase 1 PI, and a strong believer in Precision medicine programs
Disclosure
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Outline
• Changes in the classical drug development paradigm
• Example1: « oldman »phase 1
• Example2: Precision medicine
• Example3: Immunotherapy
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Outline
• Changes in the classical drug development paradigm
– quoi faire des essais cliniques en 2018?
• Example1: « oldman »phase 1
• Example2: Precision medicine
• Example3: Immunotherapy
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PURPOSE
EMPHASIS
ENDPOINT
Registration value
Find MTD
Safety
20-60
Null
Define Activity
N (patients)
Toxicity (DLT)
Activity
Response (ORR)
20-200
Limited
Efficacy
Compare with SOC
Survival (PFS, OS)
200-2000
Major
Classical drug development paradigm before 2000
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PURPOSE
EMPHASIS
ENDPOINT
Registration value
Define MTD and Activity
Safety & Activity & Biomarkers
100-1000 + N (patients)
Toxicity & Response (all and selected) & Preliminary Survival
Efficacy
Compare with SOC
Survival (PFS, OS)
200-2000
Major (confirmatory)
The revolution in drug development is a change in nature and goals of early phases
Real (conditional, breakthrough)
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Postel-Vinay S et al, Annals of Oncology 2014
Postel-Vinay S et al, Annals of Oncology 2014
FDA approval on phase I/II data
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DITEP Main Indicators of Activity
Patients
Referral of patients to DITEP for inclusion in early clinical studies
Patients recruited in our studies & patients treated in early clinical trials
9
Tubingen University – Gustave Roussy Meeting Monday, June 19th, 2017
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DITEP Main Indicators of Activity
Patients
1838 patient’s referrals for inclusion in early clinical trials in 2016
443 patients with various tumor types treated in early clinical trials in 2016
Focus 2016
10
Tubingen University – Gustave Roussy Meeting Monday, June 19th, 2017
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Outline
• Changes in the classical drug development paradigm
• Example1: « oldman »phase 1
– EGFR mAB
• Example2: Precision medicine
• Example3: Immunotherapy
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Treatment advances in mCRC
0 5 10 15 20 25
Overall survival (months) 30
5 Scheithauer, 1993
12.6 Saltz, 2000
14.1 Douillard, 2000 5-FU/LV infusion
5-FU/LV bolus
BSC
17.4 Douillard, 2000
19.5 Goldberg, 2004 FOLFOX
22.6 Falcone, 2007 FOLFOXIRI
20.3 Hurwitz, 2004 IFL + bevacizumab
21.3 Saltz, 2008 XELOX/FOLFOX + bevacizumab
23.5 Van Cutsem, 2011 FOLFIRI + cetuximab
Douillard, 2011 FOLFOX + panitumumab 23.9
22.8 Bokemeyer, 2011 FOLFOX + cetuximab
30 30 Alan P. Venook, 2014
FOLFIRI + bevacizumab cetuximab
28.7
25 Heinemann, 2014
FOLFIRI + cetuximab bevacizumab
Chemotherapy + bevacizumab cetuximab / cetuximab bevacizumab
FOLFIRI
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Cunningham N Engl J Med
2004;351:337
IRINOTECAN + CETUXIMAB in 2nd LINE : BOND TRIAL
Cunningham N Engl J Med 2004;351:337
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Membrane
P
Ligand
EGFR
P PIP3
AKT1/2
mTOR
PIP2
PDK1/2
eIF4E
4EBP1
p70S6K GSK3
Voie
PI3K/AKT
Voie
Ras/MAPK
transcription Inhibition apoptose Proliferation Angiogenèse Migration
PI3K
PTEN
Grb
hSOS
MEK1
ERK1/2
Ras
Raf1
Prolifération cellulaire
Inhibition apoptose
PLC DAG PKC
IP3
Voie PLC
STAT
STAT
Voie STAT
La voie de l’EGFR
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KRAS Status Responders* Non
responders*
Total
KRAS mutation (%) 0 (0) 13 (100) 13
Wildtype (%) 11 (65) 6 (35) 17
p=0.0003
Lièvre A et al. Cancer Res 2006.
KRAS Mutation and Anti-EGFR therapy
in advanced colorectal cancer
* Response according to RECIST criteria
Wildtype
mutated KRAS
Overall survival according to KRAS mutation
16.3 months
6.9 months p=0.016
0
25
50
75
100
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0
Months
Pe
rce
nt
surv
ival
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20-30 pts
Escalation Expansion
Classical Phase I
Phase I/II trial
Escalation Expansion
Phase I design modifications
Combo with A
Combo with B
Combo with C
Combo with D
20-30 pts
20-30 pts
20-30 pts
20-30 pts
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20-30 pts
Escalation Expansion
Classical Phase I
Phase I/II trial
Escalation Expansion
Phase I design modifications
Combo with A
Combo with B
Combo with C
Combo with D
20-30 pts
20-30 pts
20-30 pts
20-30 pts
RADIATION COMBO
HEMATOLOGICAL DISEASE
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Outline
• Changes in the classical drug development paradigm
• Example1: « oldman »phase 1
• Example2: Precision medicine
– We are still believers
• Example3: Immunotherapy
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DNA-Guided Precision Medicine for Cancer: A Case of Irrational Exuberance?
Emile E. Voest and Rene Bernards Jan 2016
September 29, 2016
8 SEPTEMBER 2016 | VOL 537 | NATURE | S63
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Conceptual evolution of Cancer treatment
Few therapeutic options to treat
tumors:
- Surgery
- Radiotherapy
- Few chemotherapies
Increase on therapeutic options
allowed specific treatments for
different tumor types:
-Combined chemo-radiation
-Specific protocols
Disease guided
approach
Pathological guided
approach
Clinical Oncology Pathological Oncology Molecular Oncology
Targeted agents that work in specific
molecular alterations:
-Broad knowledge of molecular tumor
biology and immune context
Molecular & immune
approach
Nowadays
Immune Oncology
Modified f rom J Rodon
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SANGER sequencing
RT-PCR Sequenom/ SNAPshot NGS
Technology has improved…
WES/RNAseq
MacConaill L E , Garraway L A JCO 2010;28:5219-5228
Decreasing costs
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Molecular profiling
Identification of the molecular alteration
Targeted therapy according to the molecular profile
Tumor Specimen
Precision Medicine: To identify and hit the target A virtuous circle (I)
Can molecular profiling improve patient outcome ?
MOSCATO: MOlecular Screening for CAncer Treatment Optimization
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Selected Molecular Profiling Initiatives and Genotype-Matching to Clinical Trials
Group Sample Size
Platform Fresh Biopsy vs FFPE
Germ-line Control
Number and % of “Matched” Patients in Genotype-Matched Clinical Trials
Gustave Roussy MOSCATO
1,035 40-75 gene panels (Life) + CGH (Agilent) + RNA Seq
Fresh biopsy Yes 199/1035 = 19%
Institut Curie 741 46 gene panel (Life) + CNA (Affymetrix) +IHC
Fresh biopsy No 195 randomized/741 = 26%
BCCA 100 Whole genome Fresh biopsy Yes 1/100 = 1%
MD Anderson 2,000 11-50 gene panels (Life)
FFPE No 83/2000 = 4%
Princess Margaret
1,640 23-48 gene panels (Ilumina, Life)
FFPE Yes 92/1640 = 5.6%
24
Massard et al. Cancer Dis 2017; LeTourneau et al. Lancet Oncol 2015; Laskin et al. Cold Spring Harb Mol Stud 2015; Meric-Bernstam et al. J Clin Oncol 2015; Stockley, Bedard et al. Genome Med 2016.
CNA = Copy number alterations; IHC = Immunohistochemistry
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Courtesy J Rodon
Courtesy A Bardelli
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20-30 pts
Escalation Expansion
Classical Phase I
Phase I/II trial
X 100 selected pts Molecular enrichment
Escalation Expansion
Phase I design modifications
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Outline
• Changes in the classical drug development paradigm
• Example1: « oldman »phase 1
• Example2: Precision medicine
• Example3: Immunotherapy
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PD-1/ PD-L1
Blockade
Mel RCC NSCLC
Bladder
HNSCC
Gastric
Hodgkin
B-Cell NHL
MSI CRC
Ovarian TNBC
Mesothelioma
HCC
Eso phageal
SCLC
Biliary Tract
Anal
MCC
Thymic Carcinoma
MMRd GBM
US approvals
Courtsey A Marabelle
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20-30 pts
Escalation Expansion
Classical Phase I
Multiple parallel expansion cohorts in Phase I Long-term follow-up
100-1000 patients +/- immune enrichment
Escalation Expansion
Phase I design modifications
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Challenge #1: How do we identify sensitive disease?
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Challenge #2: How do we overcome resistance to immune checkpoint blockade therapy?
?
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Challenge #3: new patterns of response/progression?
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Inclusion :
Novembre 2012
Decembre 2012
Janvier2013
Février 2013
Mars 2013
Juillet 2013
Pseudoprogression in melanoma patients
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Identifier les candidats: Biomarqueurs
06/10/2015 30/11/2015
And progression?
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Hyperprogressive disease (HPD): a new pattern of progression
Champiat et al, Clin Cancer Res 2016
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Challenge #4: How do we combine IO?
“We are not on the right path,” Khleif tells me. “Currently there are a lot of combination clinical trials
and some of those trials are not based on science.”
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Aknowledgements: MOSCATO Team Steering Committee Jean-Charles Soria (PI) Fabrice André Gilles Vassal Alexander Eggermont
Investigators Christophe Massard Antoine Hollebecque Charles Ferte Rastislav Bahleda Eric Angevin Andreea Varga Anas Gazzah Sophie Postel-Vinay Jean-Marie Michot Eric Deutsch Caroline Even Jean-Pierre Armand
Radiologists Thierry de Baere Frédéric Deschamps Lambros Tselikas Vania Tacher
Pathologists Jean Yves Scoaezec Philippe Vielh Cécile Charpy
Statistics Marie-Cécile Le Deley
Dorota Gajda
Aljosa Celebic
Silvia Rosellini
Study Coordinator Maud Ngo-Camus
Fanny Wunder
Aurélie Abou Lovergne
Lisa Lambert
Siham Gouissem
Felicien Vanié
Biologists Ludovic Lacroix
Nathalie Auger
Valérie Koubi-Pick
Benoush Abedi
Romy Chen Min Tao
Vladimir Lazar
Catherine Richon
Clément Mazoyer
Bastien Job
Equipe Médecine personnalisée
Equipe ET EXTRA
Funded by
Philantropy and French Grants
And Industrial partnerships
• SANOFI-AVENTIS
• Genentech
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Acknowledgements Jean-Charles Soria
Vincent Ribrag
Eric Deutsch
Antoine Hollebecque
Andrea Varga
Aurélien Marabelle
Sophie Postel-Vinay
Eric Angevin
Rastislav Bahleda
Anas Gazzah
Jean-Marie Michot
Capucine Baldini
Patricia Martin
Jessica Menis
Stéphane Champiat
Yolla El Dakdouki
Loic Verlingue
Benjamin Besse