Adjuvant Olaparib Approved for Germline BRCA-Mutated HER2-Negative Early Breast Cancer

AstraZeneca and MSD recently announced the approval of olaparib (Lynparza) in the United States for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer, treated previously with chemotherapy before or after surgery, according to a press release.¹

Approval is based on results of the phase 3 OlympiA Trial (NCT02032823), the results of which were presented at the American Society of Clinical Oncology 2021 Annual Meeting and published in the New England Journal of Medicine.² Results of this trial demonstrated a “statistically significant and clinically meaningful improvement in invasive disease-free survival,” per the press release, including a reduction in the risk of invasive breast cancer recurrences, second cancers, or death, by 42% (vs placebo; hazard ratio, 0.58; 95% CI, 0.46-0.74).

Updated OlympiA trial results also demonstrated a statistically significant and clinically meaningful improvement in overall survival, a key secondary endpoint; risk of death was reduced by 32% vs placebo (HR, 0.68; 95% CI, 0.50-0.91). Safety and tolerability were “in line with that observed in prior clinical trials.”

Additional data will be presented at a European Society for Medical Oncology (ESMO) virtual plenary on March 16.

References

1. Lynparza approved in the US as adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer. News release. AstraZeneca. March 11, 2022. Accessed March 14, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/lynparza-approved-in-the-us-as-adjuvant-treatment-for-patients-with-germline-brca-mutated-her2-negative-high-risk-early-breast-cancer.html
2. Tutt ANJ, Garber JE, Kaufman B, et al; for the OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer. N Engl J Med. 2021;384(25):2394-2405. Doi:10.1056/NEJMoa2105215