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|Amgen Announces Top-Line Results Of Phase 3 Trebananib (AMG 386) TRINOVA-1 Trial In Recurrent Ovarian Cancer|
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
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
TRINOVA-1 Trial Design (NCT01204749)
Other ongoing Phase 3 studies of trebananib include TRINOVA-2 and TRINOVA-3. TRINOVA-2 is evaluating whether trebananib plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by PFS in recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer. TRINOVA-3 is evaluating trebananib or placebo in combination with paclitaxel and carboplatin in the first-line treatment of epithelial ovarian, primary peritoneal or fallopian tube cancer.
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1 Ovarian Cancer Key Statistics,