Ioana Marcu, Eric M McLaughlin, Silpa Nekkanti, Wafa Khadraoui, Julia Chalif, Jessica Fulton, David O'Malley, Laura M Chambers
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niraparib significantly prolonged progressionfree survival versus placebo patients platinumsensitive recurrent ovarian cancer psroc regardless germline brca mutation gbrcam status nora analysis reports final data overall survival os randomised doubleblind placebocontrolled phase 3 trial enrolled patients across 30 centres china 26 september 2017 2 february 2019 clinicaltrialsgov nct03705156 eligible patients histologically confirmed recurrent predominantly highgrade serous epithelial ovarian cancer fallopian tube carcinoma primary peritoneal carcinoma histological restrictions gbrcam received 2 prior lines platinumbased chemotherapy patients randomised 21 receive niraparib placebo stratification gbrcam status time recurrence following penultimate platinumbased chemotherapy response last platinumbased chemotherapy following protocol amendment starting dose individualised 200 mgday patients bodyweight 77 kg andor platelet count 150 103l baseline 300 mgday otherwise os secondary endpoint totally 265 patients randomised receive niraparib n 177 placebo n 88 249 940 received individualised starting dose 14 august 2023 median followup os 579 months iqr 548616 median os 95 ci niraparib versus placebo 515 414589 versus 476 333not evaluable ne months hazard ratio hr 086 95 ci 060123 overall population 560 361ne versus 476 316ne months hr 086 95 ci 046158 patients gbrcam 465 410ne versus 469 318ne months hr 087 95 ci 056135 without new safety signals identified myelodysplastic syndromesacute myeloid leukaemia occurred three 17 niraparibtreated patients niraparib maintenance therapy individualised starting dose demonstrated favourable os trend versus placebo psroc patients regardless gbrcam status zai lab shanghai co ltd national major scientific technological special project significant new drugs development 2018 china grant number 2018zx09736019