BioCentury
ARTICLE | Clinical News

Olaparib: Additional Phase II data

May 27, 2013 7:00 AM UTC

A retrospective analysis of data from a subgroup of 218 patients with known breast cancer early onset (BRCA) mutation status in a double-blind, international Phase II trial in 265 patients with platinum-sensitive relapsed ovarian cancer showed that twice-daily 400 mg oral olaparib as maintenance therapy significantly improved median PFS vs. placebo in patients with germline BRCA mutations (11.2 vs. 4.1 months, p<0.001). An interim analysis of OS in the overall population showed that median OS was 29.8 months for olaparib vs. 27.8 months for placebo. In patients with BRCA mutations, median OS was 34.9 months for olaparib vs. 31.9 months for placebo. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June. ...