AstraZeneca, Merck & Co.'s PARP inhibitor Lynparza gains EU approval in breast cancer

AstraZeneca and Merck & Co. announced Wednesday that the European Commission approved Lynparza (olaparib) as a monotherapy for the treatment of adults with germline BRCA1/2-mutations, and who have HER2-negative locally-advanced or metastatic breast cancer. The companies noted that the decision makes the drug the first PARP inhibitor cleared in the EU in this indication.

Specifically, Lynparza is authorised for use in patients who have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless they were unsuitable for these treatments. Patients with hormone receptor-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.

According to AstraZeneca and Merck, approval of Lynparza was based on data from the Phase III OlympiAD trial, results of which showed that drug provided patients with a significant median progression-free survival (PFS) improvement of 2.8 months versus chemotherapy. Data indicated that patients taking Lynparza experienced an objective response rate (ORR) of 52 percent, which was double the ORR of 23 percent for those in the chemotherapy arm.

Dave Fredrickson, executive vice president of oncology at AstraZeneca, said "with this approval, Lynparza provides patients throughout the EU with a targeted and oral chemotherapy-free treatment option for a difficult-to-treat cancer." Fredrickson added "it also reinforces the importance of testing for biomarkers including BRCA, hormone receptor and HER2 expression, helping physicians to make the most informed treatment decisions for patients."

Lynparza, which generated sales of $209 million in the fourth quarter of 2018, gained approval in 2014 in Europe for the maintenance treatment of adults with platinum-sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy. The drug later gained clearance as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status.

AstraZeneca and Merck are jointly developing Lynparza under a deal signed in 2017, with the drug being investigated in a number of tumour types, including pancreatic and prostate cancers. Earlier this year, the companies reported that the Phase III POLO study, investigating the therapy as a first-line maintenance treatment in patients with germline BRCA-mutated metastatic pancreatic cancer, met its primary endpoint, showing a significant improvement in PFS versus placebo.

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