Article Text
Abstract
Introduction Niraparib is a poly(ADP-ribose) polymerase inhibitor approved for maintenance treatment of patients with newly diagnosed or recurrent OC that responded to platinum-based chemotherapy and treatment in heavily-pretreated recurrent OC. Here we report efficacy in patients receiving the FSD and ISD in the PRIMA/ENGOT-OV26/GOG-3012 trial (NCT02655016).
Methods This double-blind, placebo-controlled, phase 3 study randomized 733 patients to receive niraparib or placebo for 36 months or until disease progression/toxicity. A protocol amendment introduced ISD: 200 mg in patients with body weight <77 kg or platelets <150,000/µL, or 300 mg in all others. The primary endpoint was PFS by blinded independent central review (BICR). IA PFS was a sensitivity analysis. At the primary analysis data cut, follow-up was 11.2 months and 17.1 months in the ISD and FSD subgroups, respectively. An ad hoc analysis of IA PFS was performed using an updated data cut with additional 6 months follow-up.
Results BICR and IA PFS were highly concordant in the overall population. Efficacy of niraparib based on IA PFS in FSD vs ISD subgroups for each data cut were similar (table 1). Dose interruptions, modifications, and hematologic toxicity were lower with the ISD. Exposure–response data supported the clinical data.
Conclusions The 200- or 300-mg ISD by baseline body weight and platelet counts demonstrated comparable efficacy while improving the safety profile of niraparib. Use of this regimen for first-line maintenance of advanced OC patients is approved by the US FDA.
Funded by: GlaxoSmithKline
NCT: NCT02655016