Merck Receives FDA Approval With First PARP Inhibitor in Metastic Breast Cancer
In July 2017, AstraZeneca and Merck (NYSE: MRK) (known as MSD outside the United States and Canada) announced a global strategic oncology collaboration to co-develop and co-commercialize LYNPARZA, the world’s first PARP inhibitor, and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. The collaboration is based on increasing evidence that PARP and MEK inhibitors can be combined with PD-L1/PD-1 inhibitors for a range of tumor types. Working together, the companies will jointly develop LYNPARZA and selumetinib in combination with other potential new medicines and as a monotherapy. Independently, the companies will develop LYNPARZA and selumetinib in combination with their respective PD-L1 and PD-1 medicines.
Recently, the U.S. Food and Drug Administration (FDA) approved LYNPARZA® (olaparib) for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), 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. Patients with hormone receptor positive (HR+) breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Patients are selected for therapy based on an FDA-approved companion diagnostic from Myriad Genetics.
Dave Fredrickson, executive vice president, head of the oncology business unit, AstraZeneca, said, “This new approval for LYNPARZA makes it the first and only PARP inhibitor approved in metastatic breast cancer, and the only PARP inhibitor approved outside of ovarian cancer. This is significant for breast cancer patients, as the identification of BRCA status, in addition to hormone receptor and HER2 status, becomes a potentially critical step in the management of their disease.”
The approval was based on data from the randomized, open-label, phase 3 OlympiAD trial, which investigated LYNPARZA (olaparib) versus physician’s choice of chemotherapy (capecitabine, eribulin or vinorelbine). In the trial, LYNPARZA significantly prolonged progression-free survival (PFS) 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). Patients with measurable disease taking LYNPARZA (n=167) experienced an objective response rate of 52 percent (95% CI 44-60), double the response rate for those in the chemotherapy arm (n=66), which was 23 percent (95% CI 13-35). Additionally, patients experienced a confirmed complete response rate of 7.8 percent for LYNPARZA compared to 1.5 percent for the chemotherapy arm. The data from the OlympiAD trial can be found in the June 2017 issue of the New England Journal of Medicine.
“Patients diagnosed with BRCA-related metastatic breast cancer are often younger than other breast cancer patients, and their disease is often much more aggressive and difficult to treat,” said Dr. Susan M. Domchek, executive director of the Basser Center for BRCA at the Abramson Cancer Center of the University of Pennsylvania, and national leader on the OlympiAD trials. “While there is currently no cure for metastatic breast cancer, today’s approval offers a new, targeted option that may help to delay disease progression for these patients.”
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