AstraZeneca (NYSE:AZN) announced today encouraging results from a phase II study in patients with platinum-sensitive relapsed serous ovarian cancer (SOC) who had received maintenance treatment with the investigational drug olaparib, after the completion of chemotherapy. The results of this study have been featured today as part of the official American Society of Clinical Oncology (ASCO) 2011 annual meeting press cast.
In this phase II, randomised, double-blind, multicenter, placebo-controlled study, olaparib 400 mg twice daily significantly extended progression free survival (PFS) by RECIST.
Olaparib also significantly prolonged the secondary endpoint of time to progression (TTP) by CA-125 or RECIST.
The majority of adverse events (AEs) were CTCAE grade 1 or 2. AEs more commonly reported with olaparib than placebo included nausea (68% vs 35%), fatigue (49% vs 38%), vomiting (32% vs 14%) and anemia (17% vs 5%).
"These results are encouraging as they suggest that olaparib may have a positive effect on PFS in women with serous ovarian cancer, and may be a valuable therapeutic option for this aggressive form of cancer," said Dr. Jane Robertson, Medical Science Director, AstraZeneca.