The global, multicenter, double-blind study involved administering trebananib plus paclitaxel or placebo plus paclitaxel to more than 900 women suffering from recurrent partially platinum-sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.
The study’s primary endpoint of progression-free survival (PFS) was met and showed 7.2 months as the median PFS for patients in the trebananib arm compared to 5.4 months in the control arm.
Secondary endpoint of overall survival (OS) is currently under primary analysis and is expected to mature in 2014. Adverse events like localised edema, nausea and alopecia were reported in the trebananib arm.
Amgen Research and Development executive vice president Dr Sean Harper said that the TRINOVA-1 study was the first of three Phase III trials designed to evaluate the safety and efficacy of trebananib in patients with ovarian cancer.
The other Phase III studies of trebananib, TRINOVA-2 and TRINOVA-3, are currently underway.