USA-based Amgen (Nasdaq: AMGN), the world’s largest independent biotech firm, has announced that the Phase III TRINOVA-1 trial evaluating trebananib (AMG 386) plus paclitaxel versus placebo plus paclitaxel in recurrent ovarian cancer met its primary endpoint of progression-free survival (PFS).
A statistically significant difference was observed 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). 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 company noted.
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