The OlympiA Phase III trial of AstraZeneca and MSD’s Lynparza (Olaparib) 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.
OlympiA is a randomized, double-blind, parallel group, placebo-controlled multi-center Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. This international study is sponsored by AstraZeneca and the NCI and is conducted by a collaboration including the Jules Bordet BrEAST clinical trials unit; Breast International Group (BIG); Frontier Science; the NRG clinical trials group; and Myriad Genetic Laboratories.
Four Frontier Science offices were involved in the OlympiA study: data management and database programming (Frontier Science Amherst, NY, and Frontier Science Scotland in Kincraig), Independent Statistical Center (Frontier Science Madison, WI), statistics and statistical programming (Frontier Science Scotland and Frontier Science Boston, MA).