Safety And Patient-Reported Outcomes In Patients Receiving Niraparib In The Prima/Engot-Ov26/Gog-3012 Trial

Introduction Niraparib is a poly(ADP-ribose) polymerase inhibitor approved for treatment in heavily pretreated patients and maintenance of patients with newly diagnosed or recurrent ovarian cancer following a response to platinum-based chemotherapy. Here we report safety and patient-reported outcomes (PROs) in the overall population and subgroups from PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016). Methods This double-blind, placebo-controlled, phase 3 study randomized 733 patients. Patients received a 300-mg QD fixed starting dose (FSD) of niraparib or placebo for 36 months or until progression/toxicity. A protocol amendment introduced an individualized starting dose (ISD): 200 mg in patients with body weight Results In the overall population, the most common grade ≥3 treatment-emergent adverse events (TEAEs) were hematologic (table 1). In patients receiving ISD, these TEAEs decreased. No treatment-related deaths occurred. PRO analysis showed no difference in niraparib-treated patients versus placebo in the overall population or in the homologous recombination deficient, homologous recombination proficient, FSD, and ISD subgroups. Conclusions ISD incorporation improved the safety profile of niraparib without compromising efficacy. Niraparib was well tolerated, with similar PRO scores across the treatment period. Hematologic toxicities were manageable through implementation of dose interruptions and reductions. Funding GlaxoSmithKline NCT: NCT02655016