Niraparib first-line maintenance significantly prolonged progression-free survival PFS among patients with newly diagnosed advanced ovarian cancer that responded to first-line platinum-based chemotherapy, regardless of homologous recombination deficiency HRD status.
Final overall survival OS results are reported. Patients and methods: Patients were randomized to niraparib or placebo, stratified by response to first-line treatment, receipt of neoadjuvant chemotherapy, and tumor HRD status. OS testing was hierarchical [overall population first, then the homologous recombination-deficient HRd population]. Other secondary outcomes and long-term safety were assessed; an updated, ad hoc analysis of investigator-assessed PFS was also conducted cut-off date, 8 April Results: The median follow-up was In the overall population, the OS hazard ratio was 1.
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Subsequent poly ADP-ribose polymerase inhibitor therapy was received by No new safety signals were observed.
Conclusions: In patients with newly diagnosed advanced ovarian cancer at high risk of recurrence, there was no difference in OS between treatment arms. In the HRd population, patients alive at 5 years were two times as likely to be progression free with niraparib treatment than placebo. Long-term safety remained consistent with the established niraparib safety profile. Keywords: PARP inhibitor; maintenance; niraparib; ovarian cancer; overall survival.
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