Phase 2 trial of AMG 386 for treatment of recurrent ovarian cancer

Amgen announced that AMG 386, combined with paclitaxel, demonstrated antitumor activity in a randomized Phase 2 trial involving 161 patients with recurrent ovarian cancer.  In this study, patients were randomized to receive paclitaxel via IV weekly, three weeks on and one week off, plus AMG 386 at 10 mg/kg (Arm A, n=53), AMG 386 at 3 mg/kg (Arm B, n=53), or placebo (Arm C, n=55).

Median progression-free survival (PFS), the study's primary endpoint, in the 10 mg/kg arm was 7.2 months versus 5.7 months in the 3 mg/kg arm and 4.6 months in the placebo group (80 percent CI, 0.59 - 0.98; p=0.17). The objective response rate, per RECIST, was 37 percent in the 10 mg/kg arm versus 19 percent in the 3 mg/kg arm and 27 percent in the placebo group. Response rate measured by serum CA-125 levels, per the guidance from the Gynecologic Cancer Intergroup (GCIG), was 71 percent in the 10 mg/kg arm versus 58 percent in the 3 mg/kg arm and 28 percent in the placebo group.

AMG 386 is a first-in-class investigational peptibody that is designed to block angiogenesis by inhibiting angiopoietin-1 and -2 (Ang1 and Ang2).

For more information call (800) 77-AMGEN or visit www.amgen.com.