Biotechnology giant Amgen (AMGN) said the Phase 3 Trinova-1 trial evaluating trebananib plus paclitaxel versus placebo plus paclitaxel in recurrent ovarian cancer met its primary endpoint of progression-free survival or PFS.
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 -resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.
In the study, a statistically significant difference was observed in PFS with a 34 percent reduction in the risk of disease progression or death. The median PFS was 7.2 months in the trebananib arm versus 5.4 months in the control arm.
The primary analysis of overall survival, a key secondary endpoint, is expected to mature in 2014 in line with previous guidance. Amgen said an early imbalance of deaths favoring the control arm was observed, but there was an overall favorable overall survival trend for trebananib in a pre-planned interim analysis.
Sean Harper, executive vice president of Research and Development at Amgen, said, ''The TRINOVA-1 study is the first of three Phase 3 trials designed to evaluate the safety and efficacy of trebananib in patients with ovarian cancer. Angiopoietin inhibition has been a focus of research at Amgen and these results suggest that the novel biology of trebananib may offer a promising approach for patients with ovarian cancer."
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