Zai Lab presented new interim overall survival, or OS, data in Chinese patients with platinum-sensitive recurrent ovarian cancer, or PSROC, from the Phase 3 NORA study for Zejula at the European Society for Medical Oncology, or ESMO, Virtual Plenary. The results showed that Zejula maintenance treatment using an individualized starting dose regimen provides a favorable OS trend irrespective of gBRCA mutation status compared with placebo, despite that 43% 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. MOS in gBRCA mutation subgroup: Not reached for patients receiving Zejula versus 47.6 months for placebo group. MOS in non-gBRCA mutation subgroup: 43.1 months for patients receiving Zejula versus 38.4 months for placebo group. 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 therapy, mOS in the ITT population: 46.3 months for patients receiving Zejula versus 34.3 months for placebo group. MOS in gBRCA mutation subgroup: Not reached for patients receiving Zejula versus 42.1 months. MOS in non-gBRCA mutation subgroup: 43.1 months for patients receiving Zejula versus 32.6 months. The final prespecified OS analysis of the NORA study is expected in 2023.
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