AMG 386 Meets Primary Endpoint in Recurrent Ovarian Cancer Trial

Amgen announced that trebananib (AMG 386) plus paclitaxel vs. placebo plus paclitaxel met its primary endpoint of progression-free survival (PFS) in its Phase 3 TRINOVA-1 trial for recurrent ovarian cancer.

TRINOVA-1 is a Phase 3 global, multicenter, randomized, double-blind, placebo-controlled study evaluating trebananib in over 900 women with recurrent partially platinum-sensitive or platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancer. Patients were randomized to receive either 15mg/kg of IV trebananib weekly plus 80mg/m² of IV paclitaxel weekly (three weeks on, one week off) or weekly IV placebo plus 80mg/m² of IV paclitaxel weekly (three weeks on, one week off).

Study results showed a statistically significant difference in PFS with a 34% reduction in the risk of disease progression or death (HR=0.66, 95% CI, 0.57, 0.77, P<0.001) in the trebananib treatment group. The median PFS was 7.2 months in the trebananib arm compared to 5.4 months in the control arm.

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

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