Sustained benefit of adjuvant olaparib in women with germline BRCA1- and BRCA2-associated high-risk HER2-negative early breast cancer: updated results from the OlympiA phase III trial.

In the OlympiA phase III trial of 1836 women with germline BRCA1/BRCA2-associated high-risk HER2-negative early breast cancer, 1-year adjuvant olaparib maintained survival benefits at 6.1 years.

• Why it matters: Earlier interim analyses showed improvements, but long-term durability and safety—especially risks like MDS/AML—needed confirmation with extended follow-up.
• What they did: The study compared 1 year of adjuvant olaparib versus placebo, reporting prespecified interim analyses for IDFS, DDFS, and OS using stratified Cox models, plus adverse events of special interest.
• The result: At a median follow-up of 6.1 years, olaparib reduced IDFS (HR 0.65, 95% CI 0.53–0.78), DDFS (HR 0.65, 95% CI 0.53–0.81), and OS (HR 0.72, 95% CI 0.56–0.93), with 6-year OS 87.5% vs 83.2% and no increased AESI risk (6.3% vs 9.3%), including MDS/AML (0.4% vs 0.7%).

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