Zai Lab to Present Two New Phase 3 Analyses for Niraparib in Ovarian Cancer at the 2023 ESMO Gynaecological Cancers Congress
One presentation will feature an ad hoc interim OS data analysis of the Phase 3 NORA trial, showing how niraparib maintenance therapy with an individualized starting dose (ISD) provided a favorable OS (OS; secondary endpoint) trend versus placebo in Chinese patients with platinum-sensitive recurrent ovarian cancer (PSROC) regardless of biomarker status.
- One presentation will feature an ad hoc interim OS data analysis of the Phase 3 NORA trial, showing how niraparib maintenance therapy with an individualized starting dose (ISD) provided a favorable OS (OS; secondary endpoint) trend versus placebo in Chinese patients with platinum-sensitive recurrent ovarian cancer (PSROC) regardless of biomarker status.
- The median overall survival (mOS) in the niraparib-treated group was numerically higher (46.3 months) compared to 43.4 months in placebo [HR=0.82; 95% CI, 0.56-1.21].
- This new data analysis explores the treatment effect of niraparib versus placebo on OS adjusted for subsequent poly (ADP-ribose) polymerase inhibitor (PARPi) use in the placebo group.
- Another presentation will feature a post hoc analysis from the randomized, double-blind, placebo-controlled Phase 3 PRIME trial, with results showing niraparib associated with improved progression-free survival (PFS) regardless of surgical timing and residual disease status compared with placebo in patients with newly diagnosed advanced ovarian cancer in China.