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news.Amgen has revealed that AMG 386, combined with paclitaxel, demonstrated antitumor activity in a randomised Phase 2 trial involving 161 patients with recurrent ovarian cancer.
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AMG 386 is an investigational peptibody that is designed to block angiogenesis by inhibiting angiopoietin-1 and -2 (Ang1 and Ang2).
In the trial, overall survival in the 10mg/kg arm was 22.5 months versus 20.4 months in the 3mg/kg arm and 20.9 months in the placebo group.
Median progression-free survival, the study’s primary endpoint, in the 10mg/kg arm was 7.3 months versus 7.4 months in the 3mg/kg arm and 5 months in the placebo group
The objective response rate, per RECIST, was 37% in the 10mg/kg arm versus 21% 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% the 10mg/kg arm versus 58% in the 3mg/kg arm and 28% in the placebo group.
The company is initiating the Trinova-1 study, a Phase 3 randomised, double blind trial evaluating AMG 386 administered in combination with weekly paclitaxel as treatment for ovarian, primary peritoneal, and fallopian tube cancers.