Trebananib plus Paclitaxel Significantly Delays Disease Progression in Patients with Recurrent Ovarian Cancer
In a phase III trial, treatment with the investigational agent trebananib plus paclitaxel resulted in a statistically significant improvement in progression-free survival in patients with recurrent ovarian cancer, according to Amgen.
Trebananib is an investigational peptibody designed to inhibit the angiopoietin axis, which is involved in angiogenesis.
TRINOVA-1 Trial
The TRINOVA-1 trial, a phase III global, multicenter, randomized, double-blind, placebo-controlled study, evaluated trebananib in over 900 women with recurrent partially platinum-sensitive or -resistant epithelial ovarian, primary peritoneal, or fallopian tube cancer. Patients were randomly assigned 1:1 to receive 15 mg/kg of intravenous trebananib weekly plus 80 mg/m2 of paclitaxel weekly (3 weeks on, 1 week off) or weekly intravenous placebo plus 80 mg/m2 of intravenous paclitaxel weekly. The primary endpoint of the study was progression-free survival.
Improvement in Progression-free Survival
A statistically significant difference was observed in progression-free survival with a 34% reduction in the risk of disease progression or death (HR = 0.66, 95% confidence interval [CI] = 0.57–0.77, P < .001). The median progression-free survival was 7.2 months in the trebananib arm vs 5.4 months in the control arm.
The primary analysis of overall survival, a key secondary endpoint, is expected to mature in 2014.
The most frequently reported adverse events in the trebananib arm were localized edema, nausea, and alopecia. Twenty percent of patients in the trebananib arm discontinued treatment due to adverse events, compared to 7% in the control arm.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
