Multicenter phase 3 trial of niraparib maintenance for platinum-sensitive recurrend ovarian cancer: overall survival results from NORA

The phase 3 NORA trial, at 30 centers in China, randomized patients with platinum-sensitive, recurrent ovarian cancer (PSROC) after at least 2 prior lines of platinum-based chemotherapy to niraparib maintenance or placebo. Analysis of the already published primary end point, progression-free survival, showed that niraparib significantly prolonged PFS. Final overall survival results have now been published. Niraparib versus placebo resulted in a trend of better OS among all randomized patients as well as among patients with germline BRCA mutations and patients without germline BRCA mutations. No new safety signals were identified, and MDS/AML was observed in 1.7% of niraparib-treated patients. The authors conclude that niraparib maintenancy therapy demonstrated a favorable OS trend versus placebo in PSROC patients, regardless of germline BRCA mutation status.