Median overall survival (mOS) was numerically longer for patients receiving ZEJULA regardless of biomarker status, at 46.3 months compared to 43.4 months in the placebo group
– No new safety issues were identified
SHANGHAI, China and CAMBRIDGE, Mass., Dec. 15, 2022 (GLOBE NEWSWIRE) — Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today presented new interim overall survival (OS) data in Chinese patients with platinum-sensitive recurrent ovarian cancer (PSROC) from the Phase 3 NORA study for ZEJULA® (niraparib) at the European Society for Medical Oncology (ESMO) Virtual Plenary.
The results showed that ZEJULA maintenance treatment using an individualized starting dose (ISD) regimen1 provides a favorable OS trend irrespective of gBRCA mutation status compared with placebo, despite that 43% (38/88) of patients in placebo arm received subsequently at least one dose of a PARP inhibitor post progression.
- mOS in the ITT population: 46.3 months for patients receiving ZEJULA versus 43.4 months for placebo group [HR=0.82; 95% CI, 0.56-1.21].
- mOS in gBRCA mutation subgroup: Not reached for patients receiving ZEJULA versus 47.6 months for placebo group [HR=0.76; 95% CI, 0.40-1.46].
- mOS in non-gBRCA mutation subgroup: 43.1 months for patients receiving ZEJULA versus 38.4 months for placebo group [HR=0.86; 95% CI, 0.53-1.38].
- No new safety signals were identified based on long-term follow-up. Median follow-up time for OS in ZEJULA and placebo arm was 45.7 and 44.5 months, respectively.
Based on the OS analysis adjusted for subsequent PARP inhibitor therapy2,
- mOS in the ITT population: 46.3 months for patients receiving ZEJULA versus 34.3 months for placebo group [HR=0.69; 95% CI, 0.45-1.07].
- mOS in gBRCA mutation subgroup: Not reached for patients receiving ZEJULA versus 42.1 months [HR=0.88; 95% CI 0.39-2.01].
- mOS in non-gBRCA mutation subgroup: 43.1 months for patients receiving ZEJULA versus 32.6 months [HR=0.62; 95% CI 0.37-1.05].
The final prespecified OS analysis of the NORA study is expected in 2023.
“We are proud to present this new interim OS data analysis from the NORA study for Chinese patients at ESMO, as it adds to the already existing body of evidence from the study to support the clinical profile of ZEJULA as a second-line maintenance therapy for ovarian cancer regardless of biomarker status,” said Josh Smiley, Chief Operating Officer, Zai Lab. “As one of the most commonly diagnosed gynecologic cancers in China, we are committed to address the urgent need for effective treatment options in ovarian cancer care for patients in China. ZEJULA is well positioned in China as the only PARP inhibitor approved as maintenance monotherapy for patients in both first-line and recurrent settings regardless of biomarker status.”
In September 2020, Zai Lab announced the detailed positive results from the NORA study, showing ZEJULA demonstrated significant progression-free survival (PFS) benefit for patients in China with platinum-sensitive, recurrent ovarian cancer, regardless of biomarker status. In NORA, 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 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).
