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Amgen Announces Top-Line Results Of Phase 3 Trebananib (AMG 386) TRINOVA-1 Trial In Recurrent Ovarian Cancer
Date:6/12/2013

THOUSAND OAKS, Calif., June 12, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that 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 (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 3 trials designed to evaluate the safety and efficacy of trebananib in patients with ovarian cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "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."

In the trebananib arm, the most frequently reported adverse events were localized edema, nausea and alopecia. The rate of discontinuation of investigational product due to adverse events was 20 percent in the trebananib arm versus seven percent in the control arm.

Approximately 22,240 new cases of ovarian cancer will be diagnosed in the United States in 2013.1 More than 70 percent of women with ovarian cancer will present with advanced disease at diagnosis and up to 80 percent of them will exp
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