CELG Reports Studies That Evaluate Benefits of ABRAXANE

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Last Update: 06-Jun-11 11:10 ET

Celgene (CELG $58.84 -0.02) reported that 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 (n=51); or temozolomide (200 mg/m2) on days 1-5 and bevacizumab (10 mg/kg IV) on days 1 and 15 of a 28 day cycle (n=42).

Starting doses were reduced following an addendum to the study: ABRAXANE was lowered to 80 mg/m2 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%.