Positive Phase III Results With Trebananib in Recurrent Ovarian Cancer
Trebananib/paclitaxel combo improves survival versus paclitaxel alone (June 12)
Positive results have been reported from a phase III study that evaluated trebananib (Amgen) plus paclitaxel versus placebo plus paclitaxel in patients with recurrent ovarian cancer. A statistically significant difference was observed in progression-free survival (PFS; the study’s primary endpoint), with a 34% reduction in the risk of disease progression or death in the trebananib arm (hazard ratio [HR], 0.66; P < 0.001). The median PFS was 7.2 months in the trebananib arm versus 5.4 months in the control arm.
In the trebananib arm, the most frequently reported adverse events were localized edema, nausea, and alopecia. The rates of discontinuation due to adverse events were 20% in the trebananib arm versus 7% in the control arm.
Approximately 22,240 new cases of ovarian cancer will be diagnosed in the U.S. 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.
The global, randomized, double-blind, placebo-controlled TRINOVA-1 trial evaluated trebananib in more than 900 women with recurrent partially platinum-sensitive or-resistant (platinum-free interval of 12 months or less) epithelial ovarian, primary peritoneal, or fallopian tube cancer. The patients were randomly assigned to receive either 15 mg/kg of intravenous (IV) trebananib weekly plus 80 mg/m2 of IV paclitaxel weekly (3 weeks on, 1 week off) or weekly IV placebo plus 80 mg/m2 of IV paclitaxel weekly (3 weeks on, 1 week off).
Trebananib is an investigational peptibody designed to inhibit the angiopoietin axis. The angiopoietin axis is involved in angiogenesis, which plays a role in the pathogenesis of several diseases. Trebananib is designed to bind to both angiopoietin-1 and -2 (Ang1 and Ang2) and to inhibit their interaction with the Tie2 receptor. Ang1 and Ang2 each mediate separate actions upon binding with Tie2. Ang1 affects vessel quality, while Ang2 influences vessel quantity. The angiopoietins are also involved in lymphangiogenesis, which has a key role in tumor metastasis.
Source: Amgen; June 12, 2013.