Phase 3 NORA data of ZEJULA (niraparib) demonstrate significant PFS benefit, regardless of biomarker status, with an improved safety profile when given with individualized starting dose regimen in Chinese women with platinum-sensitive recurrent ovarian ca
The NORA study, presented as a late-breaker oral presentation at the European Society for Medical Oncology (ESMO) 2020 Virtual Congress,
demonstrates that niraparib maintenance treatment resulted in a 68% reduction in the risk of disease progression or death in the overall study
population when compared to placebo.
An individualized starting dose regimen based on patient’s baseline weight and/or platelet count shown to be effective; lower rates
of hematological adverse events were observed with the individualized dosing group.
SHANGHAI and SAN FRANCISCO, Sept. 19, 2020 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB), an innovative commercial stage biopharmaceutical company, today announced detailed positive results from the NORA study, the Phase 3 randomized, double-blind, placebo-controlled study of ZEJULA (niraparib) as a maintenance therapy in Chinese patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) who are in a complete or partial response to platinum-based chemotherapy.
Niraparib treatment resulted in a 68% reduction in the risk of disease progression or death in the overall population (PFS HR 0.32; 95% CI, 0.23–0.45; p<0.0001). The median progression-free survival (PFS) was significantly longer for patients treated with niraparib compared to placebo: 18.3 months (95% CI, 10.9–not evaluable) versus 5.4 months (95% CI, 3.7–5.7).
- PFS in gBRCA mutation subgroup: HR 0.22; 95%CI, 0.12-0.39; p<0.0001.
- PFS in non-gBRCA mutation subgroup: HR 0.40; 95%CI, 0.26-0.61; p<0.0001.
Implementation of an individualized dosing regimen based on body weight and/or platelet count reduced the incidence of hematological treatment-emergent adverse events. Grade≥3 hematological adverse events of neutrophil count decrease, anemia, and platelet count decrease in patients treated with niraparib versus placebo were 20.3% vs. 8.0%, 14.7% vs. 2.3%, and 11.3% vs. 1.1%, respectively.
“The NORA study is the first fully powered, randomized, placebo-controlled, phase III trial evaluating a PARP inhibitor in Chinese patients with platinum-sensitive recurrent ovarian cancer,” said Dr. Xiaohua Wu, principal investigator of the NORA study, Professor and Chair of Gynecologic Oncology Department of Fudan University Shanghai Cancer Centre. “In addition to the fixed dosing regimen of niraparib, the individualized starting dose regimen is also effective and safe and should be considered the standard clinical practice for the maintenance therapy of patients with ovarian cancer.”