Final overall survival and long-term safety in the ENGOT-OV16/NOVA phase III trial of niraparib in patients with recurrent ovarian cancer

Primary results from the ENGOT-OV16/NOVA study showed that niraparib (nir) maintenance therapy (MT) significantly prolonged progression-free survival (PFS) in patients (pts) with platinum-sensitive recurrent ovarian cancer (PSROC) regardless of germline BRCA mutation (gBRCAm) or homologous recombination deficiency (HRD) biomarker status (median follow up 16.9 months). Previously reported long-term analyses on PFS2 indicated the benefit of nir MT beyond the first progression (median follow-up ≈67 months), but overall survival (OS) analyses were limited by missing data (Matulonis et al. Gynecol Oncol. 2021;162[suppl 1]: S24-S25). Recent data retrieval efforts reduced missing survival status from 17% to ≈2%, and the data cutoff was extended by 6 months. Here we report the final OS and long-term safety results in the updated dataset.