Abraxane nab-paclitaxel: Additional Phase III data

Additional data from the open-label, international Phase III CA033 trial in 529 chemotherapy-naïve patients with stage IV metastatic melanoma showed that 150 mg/m 2 Abraxane given on days 1, 8 and 15 every 4 weeks led to PFS, the primary endpoint, of 4.8 months vs. 2.5 months for dacarbazine (p=0.044). Additionally, an interim analysis of OS showed that Abraxane non-significantly improved the secondary endpoint vs. dacarbazine (12.8 vs. 10.7 months, p=0.094). The most common grade >=3 treatment-related adverse events were neuropathy and neutropenia. Median time to neuropathy improvement in patients receiving Abraxane was 28 days. Data will be presented at the Society for Melanoma Research meeting in Los Angeles in November. Earlier this month, Celgene reported top-line data showing that Abraxane met the primary endpoint of PFS (see BioCentury, Oct. 8). Celgene said it is evaluating its regulatory and clinical strategies for Abraxane in the indication. ...