Evaluation of treatment response to niraparib in patients with platinum-sensitive recurrent ovarian cancer and measurable lesions at baseline: a sub-analysis of the phase III NORA trial

Objectives: This sub-analysis investigated treatment response to niraparib maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer (PSROC) included in the NORA trial who had measurable lesions after finishing chemotherapy and before initiating niraparib. Methods: In the double-blind, phase III NORA trial, 265 adult (≥18 years) Chinese women with PSROC were randomised 2:1 to receive oral niraparib (n=177; 300 mg/day, patients with bodyweight Results: Of the 265 patients included in the NORA study, 64 (24.2%) had measurable lesions at baseline (niraparib, n=43; placebo, n=21), 21.9% (14/64) of whom had received secondary cytoreductive surgery before the last round of chemotherapy. Among patients with measurable lesions, those who received niraparib achieved a higher ORR compared with those receiving placebo (32.6 vs 14.3%; OR=2.7, 95% CI, 0.67-11.18), and niraparib also led to a higher ORR regardless of germline BRCA mutation status (gBRCA mutation: 50.0 vs 28.6%, non-gBRCA mutation: 25.8 vs 7.1%) (Table). Niraparib was well tolerated by patients in this sub-analysis, with a safety profile in-line with previous reports. Download : Download high-res image (98KB) Download : Download full-size image Conclusions: Among patients included in the NORA study with measurable lesions at baseline, niraparib maintenance therapy induced additional antitumour activity versus placebo, with a higher ORR regardless of germline BRCA mutation status, and was well tolerated. The high rates of tumour response observed for niraparib-treated patients in the NORA study further support the role of niraparib as maintenance treatment for patients with PSROC and measurable lesions after chemotherapy.