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Joyce F. Liu, MD, MPH
Joyce F. Liu, MD, MPH
Posted: Wednesday, August 27, 2025
Based on the results of the phase III FIRST/ENGOT-OV44 trial, the addition of the PD-1 inhibitor dostarlimab-gxly to first-line platinum-based chemotherapy and maintenance therapy with the PARP inhibitor niraparib improved progression-free survival in patients with advanced ovarian cancer. However, Anne-Claire Hardy-Bessard, MD, of Centre Armoricain d'Oncologie, Plérin, France, and colleagues reported no overall survival benefit. These findings were presented during the 2025 ASCO Annual Meeting (Abstract LBA5506) and published in the Journal of Clinical Oncology.
After a one-cycle run-in of platinum-based chemotherapy, with or without bevacizumab, patients with newly diagnosed stage III to IV high-grade nonmucinous epithelial ovarian cancer were randomly assigned in a 1:1:2 ratio to receive one of the following regimens: platinum-based chemotherapy plus placebo, followed by placebo maintenance (arm 1); platinum-based chemotherapy plus placebo, followed by niraparib plus placebo maintenance (arm 2); or platinum-based chemotherapy plus dostarlimab, followed by dostarlimab plus niraparib maintenance (arm 3). After PARP inhibitors were approved for first-line maintenance therapy, enrollment in arm 1 was stopped. Follow-up data were provided for a median of 45.9 months.
The efficacy analysis included 385 and 753 patients from arms 2 and 3, respectively. The median duration of progression-free survival appeared to be significantly prolonged in arm 3 vs 2 (20.6 vs 19.2 months; hazard ratio [HR] = 0.85; P = .0351). Progression-free survival was reported in subgroups with PD-L1–positive tumors (HR = 0.84), homologous recombination–deficient tumors (HR = 0.95), and concurrent bevacizumab use (yes: HR = 0.84; no: HR = 0.86). Overall survival did not seem to significantly differ between arms 3 and 2 (median, 44.4 vs 45.4 months; HR = 1.01; P = .9060).
Safety was assessed among those who received at least one dose of study treatment (n = 1,321; arms 1–3). According to the investigators, the safety results were generally consistent with the known profiles of each agent.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
