Progression-free survival and safety at 3.5 years of follow-up: results from the randomised phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer

• DOI: 10.1016/j.ejca.2023.04.024
• Publication Date: 2023-05-03T05:58:31Z
• Authors: Antonio González-...; Bhavana Pothuri; Ignace Vergote; Whitney Graybill; Domenica Lorusso; Colleen C. McCormick; Gilles Freyer; Floor Backes; Florian Heitz; Andrés Redondo; Richard G. Moore; Christof Vulsteke; Roisin E. O'Cearb...; Izabela A. Malino...; Luda Shtessel; Natalie Compton; Mansoor R. Mirza; Bradley J. Monk
• Keywords: Progression-free survival; Regimen; Maintenance therapy

To report updated long-term efficacy and safety from the double-blind, placebo-controlled, phase 3 PRIMA/ENGOT-OV26/GOG-3012 study (NCT02655016).Patients with newly diagnosed advanced ovarian cancer complete or partial response (CR PR) to first-line platinum-based chemotherapy received niraparib placebo once daily (2:1 ratio). Stratification factors were best regimen (CR/PR), receipt of neoadjuvant (yes/no), homologous recombination deficiency (HRD) status (deficient [HRd]/proficient [HRp] not determined). Updated (ad hoc) progression-free survival (PFS) data (as November 17, 2021) by investigator assessment (INV) are reported.In 733 randomised patients (niraparib, 487; placebo, 246), median PFS follow-up was 3.5years. Median INV-PFS 24.5 versus 11.2months (hazard ratio, 0.52; 95% confidence interval [CI], 0.40-0.68) in HRd population 13.8 8.2months 0.66; CI, 0.56-0.79) overall for respectively. In HRp population, 8.4 5.4months 0.65; 0.49-0.87), Results concordant primary analysis. Niraparib-treated more likely be free progression death at 4years than placebo-treated (HRd, 38% 17%; overall, 24% 14%). The most common grade ≥ treatment-emergent adverse events thrombocytopenia (39.7%), anaemia (31.6%), neutropenia (21.3%). Myelodysplastic syndromes/acute myeloid leukaemia incidence rate (1.2%) same niraparib- patients. Overall remained immature.Niraparib maintained clinically significant improvements 3.5years high risk irrespective HRD status. No new signals identified.