Lynparza's OlympiA Phase III Trial Shows Survival In Breast Cancer Patients

New findings from the Phase III OlympiA trial reveal that AstraZeneca and MSD's Lynparza (olaparib) continues to deliver significant, long-term benefits for patients with germline BRCA-mutated (gBRCAm), HER2-negative high-risk early breast cancer. The results, shared at the 2024 San Antonio Breast Cancer Symposium (#GS1-09), highlight improvements in overall survival (OS), invasive disease-free survival (IDFS), and distant disease-free survival (DDFS) over a six-year period.

Judy E. Garber, Chief of the Division of Cancer Genetics and Prevention at Dana-Farber Cancer Institute and co-principal investigator of the trial, said in a statement, “These exciting long-term data from OlympiA confirm that adjuvant treatment with olaparib for one year continues to deliver clinically meaningful survival benefit for patients with germline BRCA-mutated high-risk HER2-negative early breast cancer even after six years, with benefit persisting in all subgroups and with toxicity and pregnancy data reassuring for this generally younger group. These data reinforce the importance of germline BRCA testing at the time of diagnosis, so we can identify all eligible patients who may benefit from treatment with olaparib as early as possible.”

At a median follow-up of 6.1 years, Lynparza demonstrated a 28% reduction in the risk of death compared to placebo. Survival rates showed that 87.5% of Lynparza-treated patients were still alive versus 83.2% in the placebo group. Additionally, the drug lowered the risk of invasive breast cancer recurrence, second cancers, or death by 35% and reduced the risk of distant disease recurrence or death by the same margin. These benefits were consistent across key subgroups, including those with high-risk hormone-receptor-positive disease.

“Two years ago, Lynparza became the first and only PARP inhibitor to demonstrate a survival benefit in germline BRCA-mutated, HER2-negative and high-risk early-stage breast cancer. To see this benefit continue after six years of follow-up is tremendous for patients and reinforces how Lynparza is continuing to transform the treatment of BRCA-mutated early-stage breast cancer,” commented Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca. 

The safety profile of Lynparza remained consistent with earlier trials, with no new safety concerns identified during extended follow-up. Importantly, there was no increased risk of myelodysplastic syndrome or acute myeloid leukaemia compared to the placebo group.

Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories, stated, “The durable long-term efficacy seen in the OlympiA study reinforces Lynparza as an important treatment option for those living with this truly challenging, very aggressive form of the disease.”

The OlympiA trial was conducted by the Breast International Group (BIG) in collaboration with NRG Oncology, the US National Cancer Institute (NCI), the Frontier Science & Technology Research Foundation (FSTRF), AstraZeneca, and MSD. Lynparza is already approved in multiple countries, including the US, EU, and Japan, for treating gBRCAm, HER2-negative high-risk early breast cancer, as well as metastatic breast cancer. In the EU, approval also extends to locally advanced cases.