Updated results in Phase III trial of Abraxane (Celgene Oncology) for patients with Metastatic Melanoma

New results from the CA 033 Phase III trial of Abraxane (nab-paclitaxel), from Celgene Oncology, show a statistically significant improvement in progression-free survival in chemotherapy-na�ve patients with Metastatic Melanoma compared to patients receiving dacarbazine chemotherapy (4.8 vs. 2.5 months, respectively (HR:0.792; 95.1% CI: 0.631, 0.992; P=0.044). An interim analysis of overall survival, the secondary endpoint, shows a trend in favour of the Abraxane arm compared to treatment with dacarbazine (12.8 and 10.7 months, respectively).

Researchers say the data reflect a positive trend for overall survival. The drug's safety profile observed in the CA033 study is comparable with other pivotal clinical trials. Neuropathy was reported for 25% of patients treated with Abraxane versus 0% in the study's dacarbazine arm, with a median of 28 days until neuropathy improved. Neutropenia rates were 20% for Abraxane and 10% for dacarbazine.

Data was presented by Dr. Evan M. Hersh, lead principal investigator and Professor of Medicine at the University of Arizona College of Medicine and Arizona Cancer Center, Tucson, AZ. at the Society for Melanoma Research Congress.