February 19 2021
The Independent Data Monitoring Committee (IDMC) has concluded that the NSABP B-55/BIG 6-13/OlympiA trial crossed superiority boundary for invasive disease-free survival vs. placebo at planned interim analysis. The OlympiA Phase III trial of AstraZeneca and MSD’s Lynparza (Olaparib) in the adjuvant treatment of BRCA-mutated HER2-negative high-risk early breast cancer will move to early primary analysis and reporting following a recommendation from the Independent Data Monitoring Committee (IDMC). Based on the planned interim analysis, the IDMC concluded that the trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) and demonstrated a sustainable, clinically relevant treatment effect for Lynparza versus placebo for patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer, and recommend primary analysis now take place.
The OlympiA Phase III trial is a partnership between Breast International Group (BIG), NRG Oncology, the US National Cancer Institute (NCI), Frontier Science & Technology Research Foundation (FSTRF), AstraZeneca and MSD.11 The trial is sponsored by NRG Oncology in the US and by AstraZeneca outside the US.
Read the announcement here.