LYNPARZA® (olaparib) reduced risk of death by 32% in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer
First PARP inhibitor to demonstrate overall survival benefit in early breast cancer
Excerpt from the Press Release:
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., known as MSD outside the US and Canada, today announced further positive results from the OlympiA Phase III trial showed LYNPARZA® (olaparib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy.
These results were presented today at a European Society for Medical Oncology Virtual Plenary. The OlympiA trial is led by the Breast International Group (BIG) in partnership with the Frontier Science & Technology Research Foundation, NRG Oncology, AstraZeneca and Merck.1
In the key secondary endpoint of OS, LYNPARZA reduced the risk of death by 32% versus placebo (based on a HR of 0.68; 98.5% CI 0.47-0.97; p=0.009). LYNPARZA improved the three-year survival rate to 92.8% versus 89.1% for those on placebo. At four years, the survival benefit was maintained with 89.8% of patients treated with LYNPARZAalive versus 86.4% of those on placebo. The safety and tolerability profile of LYNPARZA in this trial was in line with that observed in prior clinical trials.
Primary results from the OlympiA Phase III trial were first presented during the 2021 American Society of Clinical Oncology Annual Meeting and are published in The New England Journal of Medicine.2 The OS data and the primary results formed the basis for the recent approval by the US Food and Drug Administration (FDA) of LYNPARZAin this setting.
Breast cancer is the most diagnosed cancer worldwide with an estimated 2.3 million patients diagnosed in 2020.3 Nearly 91% of all breast cancer patients in the US are diagnosed at an early stage of disease and BRCA mutations are found in approximately 5-10% of patients.4,5
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