Phase III Trial Results of Trebananib Combination Therapy in Ovarian Cancer
Posted: Wednesday, June 19, 2019
No significant improvement in progression-free survival was observed by adding trebananib, a peptibody that inhibits binding of angiopoietin 1 and 2 to the tyrosine kinase receptor Tie2, to chemotherapy in the first-line treatment of advanced ovarian cancer after primary or interval debulking surgery. The Lancet Oncology published these results of TRINOVA-3, a phase III, double-blind clinical trial that included more than 1,000 women from 14 countries who were followed for a median of 27.4 months.
Ignace Vergote, PhD, of Leuven Cancer Institute in Leuven, Belgium, and colleagues had undertaken the work because “inhibition of angiogenesis has shown promise in the treatment of ovarian cancer, [and] angiopoietin 1 and 2 regulate angiogenesis and vascular remodelling by interacting with Tie2.” However, median progression-free survival (the primary endpoint) was 15.9 months in the trebananib arm and 15.0 months in the placebo group (P = .36). The combination of the agent with carboplatin and paclitaxel produced no new safety signals.
Eligible patients were diagnosed with stage III to IV epithelial ovarian, primary peritoneal, or fallopian tube cancer and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Participants received six cycles of chemotherapy every 3 weeks, plus weekly intravenous trebananib or placebo. “Maintenance therapy with trebananib or placebo continued for up to 18 additional months,” the authors noted.
In the larger picture, “changes to the chemotherapy regimen, including the addition of targeted therapies, have had little success in improving overall survival,” declared Dr. Vergote and co-investigators. “A substantial unmet need in first-line therapy for ovarian cancer [remains].”
Disclosure: The study authors’ disclosure information can be found at thelancet.com.