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

Approval was based on results of the phase 3 OlympiA trial.

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