AstraZeneca and Merck (NYSE:MRK), known as MSD outside the US and Canada, today announced that the European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for LYNPARZA (olaparib) for use in patients with deleterious or suspected deleterious BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
This is the first regulatory submission for a poly ADP-ribose polymerase (PARP) inhibitor in breast cancer in Europe. If approved, the identification of a patient’s BRCA status could become a critical step in the management of their disease alongside current consideration of their hormone receptor and HER2 status. The MAA is based on data from the randomized, open-label, phase 3 OlympiAD trial, which investigated LYNPARZA versus chemotherapy (physician’s choice of capecitabine, eribulin, or vinorelbine). In the trial, LYNPARZA significantly prolonged progression-free survival compared with chemotherapy, and reduced the risk of disease progression or death by 42 percent (HR 0.58; 95% CI 0.43-0.80; P=0.0009 median 7.0 vs 4.2 months).
In January 2018, LYNPARZA was approved by the U.S. Food and Drug Administration for use in the treatment of BRCA-mutated HER2-negative metastatic breast cancer, becoming the first PARP inhibitor to be approved beyond ovarian cancer. LYNPARZA is available in nearly 60 countries and has been used to treat more than 20,000 patients. AstraZeneca and Merck are working together to bring LYNPARZA to more patients across multiple cancers.
OlympiAD is a global, randomized, open-label, multi-center phase 3 trial of 302 patients, assessing the efficacy and safety of LYNPARZA tablets (300 mg twice daily) compared to physician’s choice of chemotherapy. 205 patients were randomized to receive LYNPARZA and97 patients were randomized to receive chemotherapy.
Patients in the OlympiAD trial had germline BRCA-mutated, HER2-negative (hormone receptor-positive or triple-negative) breast cancer, and received LYNPARZA for treatment in the metastatic setting. Prior to enrollment, 71 percent of patients had received no more than two previous chemotherapy treatments for metastasized breast cancer and 28 percent of patients had received prior platinum-based chemotherapy. Also enrolled, were patients with HR+ breast cancer who had received at least one endocrine therapy (adjuvant therapy or therapy for metastatic disease) and had disease progression during therapy unless they had disease for which the endocrine therapy was considered inappropriate.
Filed Under: Drug Discovery