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LYNPARZA® (Olaparib) Shows Sustained Survival Benefits in Early Breast Cancer: OlympiA Phase 3 Trial Results

NextEdge Admin

13 Dec 2024

2 min 28 sec

MSD,HER2-negative,BRCA mutations,breast cancer

AstraZeneca and Merck (known as MSD outside the U.S. and Canada) announced long-term results from the Phase 3 OlympiA trial, showing sustained benefits of LYNPARZA (olaparib) in germline BRCA-mutated (gBRCAm), HER2-negative high-risk early breast cancer. Results, presented at the 2024 San Antonio Breast Cancer Symposium (#GS1-09), demonstrated significant improvements in overall survival (OS), invasive disease-free survival (IDFS), and distant disease-free survival (DDFS).

At a median follow-up of 6.1 years, LYNPARZA reduced the risk of death by 28% (HR 0.72; 95% CI 0.56–0.93) compared to placebo. The six-year OS rate was 87.5% with LYNPARZA versus 83.2% for placebo. LYNPARZA also lowered the risk of invasive breast cancer recurrence, second cancers, or death by 35% (HR 0.65; 95% CI 0.53–0.78) and the risk of distant disease recurrence or death by 35% (HR 0.65; 95% CI 0.53–0.81).

The benefits were consistent across subgroups, including patients with hormone receptor-positive disease. Safety data showed no new signals, and long-term follow-up found no increased risk of myelodysplastic syndrome or acute myeloid leukemia.

Judy E. Garber of Dana-Farber Cancer Institute emphasized the importance of germline BRCA testing at diagnosis to identify patients eligible for early treatment with LYNPARZA. Susan Galbraith of AstraZeneca highlighted the drug’s transformative impact, while Eliav Barr of Merck noted its durable efficacy.

LYNPARZA is approved in multiple countries for treating gBRCAm, HER2-negative high-risk early and metastatic breast cancer based on OlympiA trial results. Breast cancer remains the second most diagnosed cancer globally, with BRCA mutations affecting 5-10% of cases.