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Phase III SOLO-2 Trial Shows Significant Progression-Free Survival Benefit From Olaparib Treatment in BRCA-Mutated Metastatic Ovarian Cancer

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Positive results were announced on October 26, 2016, from the phase III SOLO-2 trial, designed to determine the efficacy of olaparib (Lynparza) tablets (300 mg twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive, BRCA-mutated relapsed ovarian cancer. Results from the trial demonstrate a clinically meaningful and statistically significant improvement of progression-free survival among patients treated with olaparib compared to placebo and provide additional evidence to support the potential use of olaparib in this patient population, according to AstraZeneca.

Importantly, the median progression-free survival in the olaparib arm of SOLO-2 substantially exceeded that observed in the phase II maintenance study in patients with platinum-sensitive relapsed ovarian cancer (Study 19).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said, “We are pleased with the robust improvement in progression-free survival demonstrated by olaparib in the SOLO-2 trial. We will work with regulatory authorities to make olaparib tablets available as quickly as possible to patients with ovarian cancer. We remain committed to investigating the full potential of olaparib, both as monotherapy and in combinations, and to identifying all patients who may benefit from this important medicine.”

Initial findings demonstrate that safety profile with olaparib tablets was consistent with previous studies. Full results of SOLO-2 will be presented at a forthcoming medical meeting.

The positive results follow the Fast Track Designation for olaparib by the U.S. Food and Drug Administration (FDA) earlier this year, in patients with BRCA-mutation–positive, platinum-sensitive, relapsed ovarian cancer.

Olaparib is the first poly ADP ribose polymerase (PARP) inhibitor approved in the United States. Olaparib capsules (400 mg twice daily) are FDA-approved as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Olaparib is approved under accelerated approval based on objective response rate and duration of response. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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