Phase II trial of olaparib and cediranib show PFS benefits in Ovarian Cancer - AstraZeneca

AstraZeneca has presented data on a Phase II study comparing the efficacy and tolerability of olaparib and cediranib in combination to olaparib alone, for the treatment of women with recurrent platinum-sensitive high-grade serous Ovarian Cancer. Ninety patients were assigned to one of two study arms: the first taking capsules of olaparib (400 milligrams [mg] twice daily) and the other taking a combination of the two drugs (200 mg olaparib in capsule form twice daily and 30 mg of cediranib by tablets once daily). The study arms were stratified by BRCA gene mutation status and receipt of prior anti-angiogenic therapy. The BRCA gene is one of the most commonly mutated genes in breast cancer.

Trial results showed a near doubling of progression-free survival benefit for the combination therapy over use of the single drug alone. As of March 2014, median progression-free survival was 9.2 months for olaparib and 17.7 months for the combination therapy, which is a significant advantage. The overall rate of toxicity was higher for patients on the combination therapy. Fatigue, diarrhea, and hypertension were the most common toxic effects, all of which were manageable. Data was presented at ASCO. Based on these results, two Phase III trials are being planned for platinum-sensitive and platinum-resistant ovarian cancer patients.