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Olaparib extends PFS in BRCA–mutated metastatic breast cancer
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A phase 3 trial designed to compare the PARP inhibitor olaparib with chemotherapy in patients with BRCA–mutated, HER-2–negative metastatic breast cancer met its primary endpoint.
Results of the OlympiAD trial showed olaparib (Lynparza, AstraZeneca) tablets — administered in twice-daily, 300-mg doses — significantly extended PFS compared with physician’s choice of capecitabine, vinorelbine or eribulin chemotherapy.
“These results are positive news for patients with BRCA–mutated metastatic breast cancer, a disease with a high unmet need, and are the first positive phase 3 data for a PARP inhibitor beyond ovarian cancer,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a company-issued press release. “This is highly encouraging for the development of our broad portfolio, which aims to treat multiple cancers by targeting DNA damage response pathways.”
The safety profile of olaparib appeared consistent with that observed in prior studies. Complete results of the OlympiAD trial will be presented at a medical meeting.
The FDA approved olaparib capsules for monotherapy of patients with BRCA–mutated advanced ovarian cancer who underwent at least three prior lines of chemotherapy. Olaparib tablets are an investigational formulation and are not approved for any use.
The OlympiAD trial included 302 patients with metastatic breast cancer. The BRACAnalysis CDx test (Myriad Genetics) determined 98% of study participants harbored germline BRCA1 or BRCA2 mutations.
“We believe the results of the OlympiAD trial support use of the BRACAnalysis CDx test to help inform treatment decisions in the metastatic breast cancer setting and will expand the patient population who can benefit from BRCA testing,” Johnathan M. Lancaster, MD, PhD, chief medical officer of Myriad Genetic Laboratories, said in a company-issued press release.
BRACAnalysis CDx received FDA approval in 2014 for the identification of patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib.