AstraZeneca and Merck announced long-term results from the OlympiA Phase 3 trial which showed LYNPARZA(olaparib) demonstrated sustained, clinically meaningful improvements in overall survival (OS), invasive disease-free survival (IDFS) and distant disease-free survival (DDFS) for people with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer. These results were presented at the 2024 San Antonio Breast Cancer Symposium (#GS1-09) and were consistent with positive primary results published in The New England Journal of Medicine. Breast cancer is the second most diagnosed cancer worldwide, with an estimated 2.3 million patients diagnosed in 2022.
About 63% of all breast cancer patients are diagnosed at an early stage of disease and BRCA mutations are found in approximately 5-10% of patients. Two years ago, LYNPARZAbecame the first and only PARP inhibitor to demonstrate a survival benefit in germline BRCA-Mutated, HER2-negative and high-risk early-stage breast cancer. When either of these genes is mutated or altered such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable.
As a result, cells are more likely to develop genetic alterations that can lead to cancer. Early breast cancer is defined as disease confined to the breast with or without regional lymph node involvement, and the absence of distant metastatic disease. In the US, the 5-year survival rate is 99.6% for localized breast cancer (only found in the breast area) and 86.7% for regional breast cancer (cancer that has spread outside the breast to nearby structures or lymph nodes).
Despite advancements in the treatment of early breast cancer, up to 30% of patients with high-risk clinical and/or pathologic features recur within the first few years and patients with gBRCA mutations are more likely to be diagnosed at a younger age than those without these mutations. Breast cancer is one of the most biologically diverse tumor types with various factors fuelling its development and progression. The discovery of biomarkers in the development of breast cancer has greatly impacted scientific understanding of the disease.
In July 2017, AstraZeneca and Merck, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize certain oncology products including LYNPARZA, the world's first PARP inhibitor, for multiple cancer types. Working together, the companies will develop these products in combination with other potential new medicines and as monotherapies. Independently, the companies will develop these oncology products in combination with their respective PD-L1 and PD-1 medicines.
Merck's focus on cancer's goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives purpose and supporting access to cancer.