AMG 386 is an investigational peptibody that is designed to block angiogenesis by inhibiting angiopoietin-1 and -2 (Ang1 and Ang2).
In the Amgen’s study patients were randomised to receive Paclitaxel via IV weekly, three weeks on and one week off, plus AMG 386 at 10mg/kg, AMG 386 at 3mg/kg, or placebo.
Reportedly, median progression-free survival (PFS), the study’s primary endpoint, in the 10mg/kg arm was 7.2 months versus 5.7 months in the 3mg/kg arm and 4.6 months in the placebo group (80% CI, 0.59 – 0.98). The objective response rate, per Recist, was 37% in the 10mg/kg arm versus 19% in the 3mg/kg arm and 27% in the placebo group. Response rate measured by serum CA-125 levels, per the guidance from the Gynecologic Cancer Intergroup (GCIG), was 71% in the 10mg/kg arm versus 58% in the 3mg/kg arm and 28% in the placebo group.
Amgen said that the results of a population pharmacokinetic/pharmacodynamic analysis were presented separately in a poster at the Annual Meeting. This analysis suggests that investigation using higher doses of AMG 386 for patients with ovarian cancer is warranted.
Beth Karlan, director of the Women’s Cancer Research Institute at Samuel Oschin Comprehensive Cancer Institute of Cedars-Sinai and director of division of gynecologic oncology at Cedars-Sinai Medical Center, said: “In this study, AMG 386 showed promising antitumor activity and extended progression-free survival.”