26 Sep Amgen Announces Results from a Phase 3 Trinova-1 Study
Amgen announced results from a Phase 3 Trinova-1 study. These results showed a significant difference was observed in progression-free survival, there was a 34% reduction in the risk of disease progression or death. The average progression-free survival was 7.2 months for patients receiving the trebananib arm versus 5.4 months in those receiving the control arm. More information on overall survival is expected to be forthcoming in 2014. Although, early analysis does show an imbalance of deaths favoring the control arm, while the overall survival trend for those receiving trebananib is favorable. “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.” The most common adverse events reported for those receiving trebananib was localized edema, nausea, and alopecia. There was a 20% discontinuation rate due to adverse events for those receiving the trebananib arm compared to 7% in the control arm.
These results are promising since approximately 22,240 new cases of ovarian cancer will be diagnosed in the United States in 2013. More than 70% of women with ovarian cancer will present with advanced disease at diagnosis and up to 80% of them will experience disease recurrence and eventually die from their disease.
Currently, the Trinova-3 (GOG 3001) study is open at Froedtert and the Medical College. This study 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.