Post-hoc analysis of NOVA study suggested that patients with low body weight (< 77 kg) or low platelet count (< 150,000/μL) may benefit from an initial starting dose of niraparib 200 mg without compromising efficacy. We aimed to prospectively assess the efficacy and safety of niraparib with an individualized starting dose (ISD) in Chinese patients.
NORA trial was conducted in 32 hospitals in China. Eligible patients were women with PSROC who had either germline
From September 26 2017 to February 2 2019, 265 patients were randomized to niraparib (n=177) or placebo (n=88); 16 patients received fixed starting dose of 300 mg and 249 patients received an ISD (300 mg, n=14; 200 mg, n=235) under the amended protocol. The median PFS was significantly longer for patients on niraparib versus placebo; 18.3 (95% CI, 10.9, not evaluable) versus 5.4 (95% CI, 3.7, 5.7) months (HR=0.32; 95% CI, 0.23–0.45; p <0.0001). Grade ≥3 treatment emergent adverse events (TEAE) occurred in 50.8% and 19.3% of patients (niraparib vs placebo), especially for hematological TEAE reported in the Table. Hematology TEAE of Grade ≥ 3 # Include PTs of platelet count decreased & thrombocytopenia.
TEAEs, n (%) Niraparib (n=177) Placebo (n=88) Neutrophil count decreased 36 (20.3) 7 (8.0) Platelet count decreased # 20 (11.3) 1 (1.1) Anaemia 26 (14.7) 2 (2.3)
Hematology TEAE of Grade ≥ 3
# Include PTs of platelet count decreased & thrombocytopenia.
This is the first study to demonstrate the efficacy and safety of niraparib in Chinese patients with PSROC. ISD of niraparib is effective and safe and should be considered a standard clinical practice in this patient population.
Zai Lab (Shanghai) Co., Ltd.
Zai Lab (Shanghai) Co., Ltd., Shanghai, China. National Major Scientific and Technological Special Project for “Significant New Drugs Development” in 2018 (No. 2018ZX09736019), China.
All authors have declared no conflicts of interest.