Transcript REVLIMID
Recent Advances In The Development Of Innovative Therapies. The Celgene Pipeline Jean Caraux, MD PhD BTG, Hong Kong - February 23th 2013 Targeting Unmet Medical Needs Hematologic Malignancies B-Cell Malignancies T-Cell Malignancies MDS and Myeloproliferative disorders • Myeloma • CTCL • MDS • CLL • PTCL • AML • MF • NHL REVLIMID POMALYST ISTODAX REVLIMID VIDAZA POMALYST 2 Targeting Unmet Medical Needs Solid tumors High Medical Need Malignancies • Metastatic • Pancreatic Breast Cancer Cancer • NSCLC • Melanoma Abraxane 3 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 4 Pomalidomide-dex vs dex (phase III) Improved Overall Survival n= 455 HR=0.53 5 5 Pomalidomide : Myelofibrosis • 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 6 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 7 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 8 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 nabpaclitaxel arm – Observed early and maintained throughout the study 9 Pancreatic : Abraxane + Gemcitabine Improved Overall Survival in phase III Variable ABI007/Gemcitabine (N=431) Gemcitabine (N=430) Deaths 333 (77%) 359 (83%) Censored 98 (23%) 71 (17%) 8.5 6.7 0.72 7.89 - 9.53 6.01 - 7.23 0.617 – 0.835 6 month 67% 55% 9 month 48% 36% 12 month 35% 22% 18 month 16% 9% 24 month 9% 4% Median (months) 95% Confidence Interval Hazard Ratio HR A+G/Ga P-value b 0.0000152 Survival Rate (%) at 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 10 Apremilast Adressing Frequent Unmet Needs Apremilast Advantages Large Underserved Patient Populations Targets high unmet need Clinical activity in several inflammatory diseases PsA Safe and well tolerated Convenient – oral Near-term Milestones • Ph III ESTEEM data in psoriasis expected in Q1 • Ph III PALACE-4 data in treatmentnaïve PsA expected in Q1 Psoriatic Arthritis ~1M Psoriasis (moderate to severe) ~2.5M Ankylosing Spondylitis ~2.5M ~ 6M patients in US / EU only • Submit NDA for PsA in H1 11 CC-292 (Avila) Potential of BTK Inhibition Monocytes B Cells Mast Cells Osteoclasts RA, IBD RA, Multiple Myeloma, Osteolytic Bone Disease Leukemia, Lymphoma Allergy, MS Asthma, RA SLE, ITP Vasculitides 12 Focused Research and Early-Stage Development Exploit Our Unique Advantages • IMiD technology platform • Epigenetics • Kinase inh. (TORKi, DNAPKi) • Tumor progenitors Highlights • Avilomics – protein silencing • Advanced 7 programs into Ph I over last 2 yrs Leverage Strategic Collaborations & Disruptive Technologies ACE-011 ACE-536 ARRY-111 ARRY-382 Genetic Lesion DOT1L + HMTs Cancer Stem Cell Targets Cancer Metabolism Antibody Conjugates Novel Antibody Targets Ca ImmunoRx Target • Expanded biologics program • Enhanced platforms to accelerate discovery 13 Thank you February 3013