Updated results from the OlympiA Phase III trial revealed that AstraZeneca and MSD’s Lynparza (olaparib) continues to show significant, clinically meaningful improvements in overall survival (OS), invasive disease-free survival (IDFS), and distant disease-free survival (DDFS) at six years for patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer.
These findings, presented at the San Antonio Breast Cancer Symposium 2024 (SABCS) (#GS1-09), further build on the positive primary results previously published in The New England Journal of Medicine.
After a median follow-up of 6.1 years in eligible patients who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy, Lynparza reduced the risk of death by 28% (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.56-0.93) compared to placebo. Additionally, 87.5% of patients treated with Lynparza remained alive, compared to 83.2% of those receiving placebo.
Lynparza also showed sustained and clinically meaningful benefits in both primary and secondary endpoints. It reduced the risk of invasive breast cancer recurrence, second cancers, or death by 35% (HR 0.65; 95% CI: 0.53-0.78) and lowered the risk of distant disease recurrence or death by 35% (HR 0.65; 95% CI: 0.53-0.81) compared to placebo. These benefits were consistent across all key subgroups, including patients with high-risk, hormone-receptor-positive disease.
Dr. Judy E. Garber, Chief of the Division of Cancer Genetics and Prevention at Dana-Farber Cancer Institute and co-principal investigator of the trial, emphasized the importance of these results. She stated, “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. The benefit persists across all subgroups, and the toxicity and pregnancy data are reassuring for this generally younger group. These data reinforce the importance of germline BRCA testing at diagnosis to identify eligible patients who may benefit from olaparib treatment as early as possible.”
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, highlighted the groundbreaking nature of these findings. She stated, “Two years ago, Lynparza became the first and only PARP inhibitor to demonstrate a survival benefit in germline BRCA-mutated, HER2-negative, high-risk early-stage breast cancer. To see this benefit persist after six years of follow-up is tremendous for patients and reinforces how Lynparza continues to transform the treatment of BRCA-mutated early-stage breast cancer.”
Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer at Merck Research Laboratories, also commented on the trial’s significance: “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 safety and tolerability profile of Lynparza in this trial was consistent with prior clinical trials, and no new safety signals were identified with longer follow-up. Importantly, no evidence of an increased risk of myelodysplastic syndrome or acute myeloid leukemia was observed compared to those on placebo.”
The OlympiA trial is coordinated 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 has received regulatory approval in the US, EU, Japan, and many other countries for treating gBRCAm, HER2-negative high-risk early breast cancer. It is also approved for patients with gBRCAm, HER2-negative metastatic breast cancer. In the EU, this indication includes patients with locally advanced breast cancer as well.
These long-term results underscore Lynparza’s role as a transformative therapy for patients with gBRCAm HER2-negative breast cancer, offering hope for improved outcomes and enhanced quality of life. By addressing the aggressive nature of this disease with durable efficacy and a reassuring safety profile, Lynparza continues to set a high standard for targeted cancer treatments.
