Post on 26-May-2015
Recent Advances In The Development Of Innovative Therapies.
The Celgene Pipeline
Jean Caraux, MD PhD
BTG, Hong Kong - February 23th 2013
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Targeting Unmet Medical NeedsHematologic Malignancies
• Myeloma
• CLL
• NHL
• MDS
• AML
• MF
B-CellMalignancies
T-CellMalignancies
MDS and Myeloproliferative
disorders
REVLIMID
POMALYSTISTODAX
REVLIMIDVIDAZA
POMALYST
• CTCL
• PTCL
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Targeting Unmet Medical NeedsSolid tumors
• Metastatic Breast Cancer
• NSCLC
High Medical Need Malignancies
• Pancreatic Cancer
• Melanoma
Abraxane
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Major Recent Accomplishments
Multiple Myeloma
• Lenalidomide (REVLIMID ®)
• Approved in China for RRMM,
• Reimbursed in Taiwan
• Pomalidomide (POMALYST®)
• Achieved an overall survival benefit in a Ph III trial for RRMM after failure of prior options
• Approved in the US
• Access for Asian patients being set up
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Pomalidomide-dex vs dex (phase III) Improved Overall Survival
n= 455 HR=0.53
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• Global phase III trial fully accrued; Data expected H1:13
• Combination of pomalidomide and prednisone is active in myelofibrosis
• 62% of patients achieved transfusion independence
Pomalidomide : Myelofibrosis
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Major Recent Accomplishments
Lymphomas
• MCL : Lenalidomide filed for approval in US
• FL : R2 highly active in first-line, phase III ongoing
• DLBCL : R2-CHOP21 is active and well tolerated.
MDS and AML
• CC-486 (oral aza) : Initiated Ph III program,Chronic hypomethylation
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Major Recent Accomplishments
Nab-paclitaxel (ABRAXANE®)
• NSCLC : approved (US)
• Pancreatic Cancer : Demonstrated an overall survival benefit in Ph III trial
• Melanoma : Achieved the primary endpoint of PFS with OS trend in Ph III trial
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Metastatic Melanoma : Abraxane Improved PFS in phase III vs dacarbazine
• 529 pts• nab-Paclitaxel superior to standard DTIC
chemotherapy
• PFS (primary endpoint) : – significantly improved vs dacarbazine– 4.8 vs 2.5 months (P = 0.044)
• OS :– Interim OS analysis : trend in favor of the nab-
paclitaxel arm– Observed early and maintained throughout the
study
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Pancreatic : Abraxane + GemcitabineImproved Overall Survival in phase III
Variable ABI-007/
Gemcitabine(N=431)
Gemcitabine(N=430)
Hazard RatioHR A+G/Ga P-value b
Deaths 333 (77%) 359 (83%)
Censored 98 (23%) 71 (17%)
Median (months) 8.5 6.7 0.72 0.0000152
95% Confidence Interval 7.89 - 9.53 6.01 - 7.23 0.617 – 0.835
Survival Rate (%) at
6 month 67% 55%
9 month 48% 36%
12 month 35% 22%
18 month 16% 9%
24 month 9% 4%
a95% CI from stratified Cox model bStratified log-rank using IVRS strata of region, KPS, and presence of liver mets Confidential – for internal use only
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Near-term Milestones
Apremilast Advantages
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Targets high unmet need
Clinical activity in several inflammatory diseases
Safe and well tolerated
Convenient – oralPsoriaticArthritis
Large Underserved Patient Populations
~ 6M patients in US / EU only
• Ph III ESTEEM data in psoriasis expected in Q1
• Ph III PALACE-4 data in treatment-naïve PsA expected in Q1
• Submit NDA for PsA in H1
~1M ~2.5M~2.5M
AnkylosingSpondylitis
Psoriasis (moderate to severe)
PsA
Apremilast Adressing Frequent Unmet Needs
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CC-292 (Avila)Potential of BTK Inhibition
Osteoclasts
RA, IBD Leukemia,Lymphoma
SLE, ITPVasculitides
Allergy, MSAsthma, RARA, Multiple
Myeloma,Osteolytic Bone
Disease
Monocytes B Cells Mast Cells
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Focused Research and Early-Stage Development
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Highlights
Leverage Strategic Collaborations & Disruptive Technologies
• Advanced 7 programs into Ph I over last 2 yrs
• Expanded biologics program
• Enhanced platforms to accelerate discovery
ARRY-111ARRY-382
ACE-011ACE-536
CancerMetabolism
Cancer StemCell Targets
Genetic LesionDOT1L + HMTs
Novel AntibodyTargets
Ca ImmunoRxTarget
Exploit Our Unique Advantages
• IMiD technology platform
• Epigenetics
• Kinase inh. (TORKi, DNAPKi)
• Tumor progenitors
• Avilomics – protein silencing
AntibodyConjugates
Thank you
February 3013