BioCentury
ARTICLE | Clinical News

Trebananib: Phase III data

June 17, 2013 7:00 AM UTC

Top-line data from the double-blind, international Phase III TRINOVA-1 trial in over 900 women with recurrent partially platinum-sensitive or platinum-resistant ovarian cancer, primary peritoneal cancer or fallopian tube cancer showed that once-weekly 15 mg/kg IV trebananib plus paclitaxel met the primary endpoint of improving median PFS vs. placebo plus paclitaxel (7.2 vs. 5.4 months, p<0.001). Amgen said that a pre-planned interim analysis of the secondary OS endpoint showed a trend in favor of trebananib. Final OS data are expected to mature in 2014. The most frequent adverse events reported in the trebananib arm were localized edema, nausea and alopecia. The rate of discontinuation due to adverse events was 20% in the trebananib arm vs. 7% for placebo. ...