Recent Advances In The Development Of Innovative Therapies The Celgene Pipeline
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Transcript of Recent Advances In The Development Of Innovative Therapies The Celgene Pipeline
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