Trebananib (Amgen) success in Phase III trial for Ovarian Cancer
The Phase III TRINOVA-1 trial evaluated trebananib (from Amgen) plus paclitaxel versus placebo plus paclitaxel in recurrent Ovarian Cancer and met its primary endpoint of progression-free survival (PFS). A statistically significant difference was observed in PFS with a 34 percent reduction in the risk of disease progression or death (HR = 0.66, 95 percent CI, 0.57, 0.77, p<0.001). 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 (OS), a key secondary endpoint, is expected to mature in 2014 in line with previous guidance. Although an early imbalance of deaths favoring the control arm was observed, there was an overall favorable OS trend for trebananib in a pre-planned interim analysis.
The TRINOVA-1 study is the first of three Phase III trials designed to evaluate the safety and efficacy of trebananib in patients with Ovarian Cancer.
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