AMG 386: Updated Phase II data

Updated data from a double-blind Phase II trial in 161 patients showed that 3 mg/kg IV AMG 386 plus paclitaxel significantly improved median PFS vs. placebo plus paclitaxel (7.4 vs. 5 months, p=0.016) after a median follow-up of about 64-66 weeks, while the 10 mg/kg dose non-significantly improved the endpoint (7.3 months, p=0.113). Low- and high-dose AMG 386 also non-significantly improved median overall survival (OS) vs. placebo (20.4 and 22.5 months, respectively, vs. 20.9 months; p=0.33 and p=0.081). Response rates as measured by serum CA-125 levels were 58% and 71% for low- and high-dose AMG 386, respectively, vs. 28% for placebo. Amgen said the study was not powered to show statistical significance between treatment arms, and that the trial was intended only to provide an estimated PFS for AMG 386 in combination with paclitaxel relative to the control. ...