ABRAXANE and bevacizumab clinical studies on unresectable melanoma presented at ASCO 2011

Celgene International Sàrl (Nasdaq:CELG) today announced that results from two investigator initiated studies including ABRAXANE (paclitaxel albumin-bound particles for injectable suspension), and bevacizumab in unresectable melanoma were presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, IL.

In the first study, patients were given either ABRAXANE (100 mg/m²) on days 1, 8 and 15 carboplatin (AUC 6 IV) on day 1 and bevacizumab (10 mg/kg IV) on days 1 and 15, each of a 28 day cycle>2) on days 1-5 and bevacizumab (10 mg/kg IV) on days 1 and 15 of a 28 day cycle>2 and carboplatin to AUC 5. For both arms, 6-month progression-free survival rate was the primary endpoint.

After a median 4-cycles of therapy (range 1-27+), the 6-month progression free survival (PFS) rate for patients in the ABRAXANE arm was 54.9% (95% CI; 42.8%-70.4%) and the one-year PFS rate was 27.5% (95% CI: 17.6%-42.9%). Median PFS for patients in the ABRAXANE arm was estimated to be 6.6 months and the median overall survival (OS) was estimated to be 13.9 months. The 12-month survival rate was 58.1% (95% CI: 45.9%-73.6%). The confirmed response rate was 33.3%.

In the temozolomide arm, patients received a median 4-cycles of therapy (range 1-30+). The 6-month PFS rate was 32% (95% CI; 20.5-50.1%). Median PFS for patients in the temozolomide arm was estimated at 3.8 months and the median OS was 12.3 months.

The most common grade 3 or higher adverse events in the ABRAXANE arm (following addendum) were neutropenia (43%), leukopenia (26%), thrombocytopenia (17%) and anemia (17%). In the temozolomide arm, the most common grade 3 or higher adverse events were vomiting (12%), fatigue (10%), leukopenia (10%) and neutropenia (10%).

In the second, single-arm study, patients received ABRAXANE (150 mg/m²) on days 1, 8 and 15, and bevacizumab (10mg/m²) on days 1 and 15 of a 28-day cycle.

The PFS rate at 4 months, which was the primary endpoint of the study, was 73%. The median PFS for patients in the study was 7.63 months (95% CI: 5.56 to 9.93 months). The median overall survival was 16.8 months (95% CI: 11.3 to 20.7 months). The 12-month survival rate was 62% and the 2-year survival rate was 30%. The response rate was 36.0%.

In the study, the most common grade 3 or higher adverse events related to study drug were neutropenia (20%), neuropathy (14%), mucositis (8%) and fatigue (6%).