First Medicine Specifically Targeting BRCA Mutations to Demonstrate Statistically Significant Improvement in Invasive Disease-Free Survival in Adjuvant Setting Following Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the first presentation of data from the Phase 3 OlympiA trial, in which LYNPARZA demonstrated a statistically significant improvement in its primary endpoint of invasive disease-free survival (iDFS) versus placebo in the adjuvant treatment of patients with germline BRCA1/2 mutations and high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer following definitive local treatment and neoadjuvant or adjuvant chemotherapy. Results will be presented during the Plenary Session at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting on June 6 (Abstract LBA#1). Results were also published today in the New England Journal of Medicine.
An estimated 2.3 million people were diagnosed with breast cancer worldwide in 2020, and germline BRCA mutations are found in approximately 5% of patients with breast cancer.
OlympiA is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial. In the overall trial population of 1,836 patients, results showed LYNPARZA (n=921) reduced the risk of invasive breast cancer recurrences, second cancers or death by 42% (HR=0.58 [99.5% CI, 0.41-0.82]; p