Biotechnology company Amgen Inc. (AMGN) Friday said its investigational drug AMG 386, combined with paclitaxel, showed antitumor activity in a mid stage trial involving patients with recurrent ovarian cancer.
AMG 386 is an investigational peptibody designed to block angiogenesis by inhibiting angiopoietin-1 and -2. Angiopoietins interact with the Tie2 receptor, which mediates vascular remodeling. The company noted that ovarian cancer remains the leading cause of gynecological cancer death in women with 5-year survival rates across all stages remaining low.
Around 161 patients were randomized to receive paclitaxel via IV weekly, three weeks on and one week off, plus weekly: AMG 386 at 10 mg/kg, AMG 386 at 3 mg/kg, or placebo. Overall survival in the 10 mg/kg arm was 22.5 months versus 20.4 months in the 3 mg/kg arm and 20.9 months in the placebo group.
Further, the company is initiating the TRINOVA-1 study, a Phase 3 randomized, double blind trial evaluating AMG 386 administered in combination with weekly paclitaxel as treatment for ovarian, primary peritoneal, and fallopian tube cancers.
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