A planned interim analysis found that the phase 3 OlympiA trial (NCT02032823) crossed the superiority boundary for its primary end point of invasive disease-free survival (iDFS) and demonstrated a sustainable, clinically relevant treatment effect for olaparib (Lynparza) versus placebo in patients with germline BRCA-mutated (gBRCAm) high-risk HER2-negative early breast cancer, according to the agent’s co-developers, AstraZeneca and Merck.1
Based on this finding, the independent data monitoring committee (IDMC) has recommended the trial move to early primary analysis and reporting.
Notably, the IDMC did not raise any new safety concerns in its communication. Moving forward, the trial will continue to assess the key secondary end points of overall survival and distant disease-free survival.
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