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Addition of trebananib to paclitaxel extends PFS in recurrent ovarian cancer
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The addition of trebananib to paclitaxel significantly extended PFS in patients with recurrent ovarian cancer compared with paclitaxel alone, according to the drug’s manufacturer.
Trebananib (AMG 386, Amgen) is an investigational peptibody that is designed to inhibit the angiopoietin axis, which is involved in angiogenesis.
The TRINOVA-1 study — the first of three phase 3 trials designed to evaluate the safety and efficacy of trebananib in patients with ovarian cancer — included more than 900 women with recurrent, partially platinum-sensitive or platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.
In the multicenter, double-blind, placebo-controlled study, all patients received 80 mg/m2 IV paclitaxel weekly (3 weeks on, 1 week off). In addition, researchers randomly assigned patients to receive either weekly 15 mg/kg trebananib, administered intravenously, or weekly placebo.
PFS served as the primary endpoint.
Median PFS was 7.2 months among patients in the trebananib arm compared with 5.4 months among patients in the placebo arm, translating to a 34% reduction in risk for disease progression or death (HR=0.66; 95% CI, 0.57-0.77), according to researchers.
A pre-planned interim analysis of OS suggested an overall favorable trend for trebananib. The primary analysis of OS is expected to mature next year.
The most frequently reported adverse events among patients 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 with 7% in the placebo arm.