Abstract

OlympiA is the first phase III randomised clinical trial (RCT) testing a PARP inhibitor as adjuvant therapy. At the first event driven interim analysis [Data CutOff 1 (DCO1), 27/03/20; median follow up (MFU) 2.5 years] OL significantly improved the primary endpoint of invasive disease-free survival (IDFS) and secondary endpoint of distant DFS (DDFS) compared with placebo (PL) [both p<0.001]. OS did not cross the pre-specified boundary (p<0.01) (Tutt et al NEJM 2021). The second pre-specified analysis of OS and updated IDFS, DDFS and safety descriptive analyses was planned after 330 IDFS events [DCO2 12/07/21; MFU 3.5 years].

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