Celgene reports 3Q12 results, cancer data

Celgene Corp. (NASDAQ:CELG) reported 3Q12 results on Thursday along with data for two of its marketed cancer drugs in potentially new indications. Abraxane nab-paclitaxel led to progression-free survival of 4.8 months vs. 2.5 months for dacarbazine (p=0.044) in the Phase III CA033 trial in 529 chemotherapy-naive patients with metastatic melanoma. Additionally, an interim analysis of overall survival showed that Abraxane improved the secondary endpoint vs. dacarbazine, but the difference was not significant (12.8 vs. 10.7 months, p=0.094). Celgene said it is evaluating regulatory and clinical strategies for Abraxane in the indication. Earlier this month, the company reported that Abraxane met the primary endpoint of PFS. The albumin stabilized nanoparticle formulation of paclitaxel is approved as second-line therapy for metastatic breast cancer and for first-line treatment of advanced non-small cell lung cancer (NSCLC) (see BioCentury Extra, Oct 2).

Celgene said oral Revlimid met the endpoints outlined in the SPA from FDA in the Phase II EMERGE (MCL-001) trial in about 134 patients with relapsed or refractory mantle cell lymphoma (MCL). Celgene did not disclose details but plans to present data from the trial at the American Society of Hematology meeting in Atlanta in December. Based on the results, Celgene plans to submit an sNDA to FDA for Revlimid to treat MCL by year end. Celgene markets Revlimid in the U.S. and EU in combination with dexamethasone to treat multiple myeloma (MM) in patients who have received at least one prior therapy and in the U.S. to treat patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS). ...