AstraZeneca: IDMC Recommends Primary Analysis For OlympiA Phase III Trial

(RTTNews) - AstraZeneca PLC (AZN.L, AZN) said the OlympiA phase III trial for AstraZeneca and MSD's Lynparza will move to early primary analysis and reporting following a recommendation from the Independent Data Monitoring Committee. 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 and showed a sustainable, clinically relevant treatment effect for Lynparza versus placebo for patients with germline BRCA-mutated high-risk HER2-negative early breast cancer.

The Independent Data Monitoring Committee did not raise any new safety concerns. The trial will continue to assess the key secondary endpoints of overall survival and distant disease-free survival.