Ann Oncol

ASCO 2025: Dostarlimab plus niraparib boosts PFS in advanced ovarian cancer

June 9, 2025

In the first-line treatment of patients with advanced ovarian cancer, the addition of dostarlimab to platinum-based chemotherapy (PBCT) and niraparib maintenance was associated with a statistically significant, but clinically modest, progression-free survival (PFS) improvement, with no difference in overall survival (OS). These findings were presented at the ASCO Annual Meeting 2025.

Study details: The phase 3 FIRST/ENGOT-OV44 trial (NCT03602859) assessed the efficacy of adding dostarlimab (anti–PD-1) to platinum-based chemotherapy (PBCT) and niraparib maintenance in patients with newly diagnosed stage III–IV high-grade nonmucinous epithelial ovarian cancer. Patients were randomized 1:1:2 into three arms: PBCT with placebo (arm 1), PBCT with niraparib maintenance (arm 2), and PBCT with dostarlimab plus niraparib maintenance (arm 3). Efficacy was assessed in arms 2 (n=385) and 3 (intention-to-treat population; n=753).

Results: The combination of dostarlimab and niraparib demonstrated a statistically significant improvement in (PFS) compared with standard therapy (median 20.6 vs. 19.2 months; hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.73-0.99; P = 0.0351). At 1, 2, and 3 years, PFS rates were modestly higher in the combination arm (75%, 44%, and 32%) vs. the niraparib-only arm (70%, 40%, and 27%). Toxicities observed were consistent with known safety profiles of the agents used in the study.

Source:

Hardy-Bessard AC, et al. (2025, May 30). Ann Oncol. Dostarlimab and niraparib in primary advanced ovarian cancer. https://pubmed.ncbi.nlm.nih.gov/40461381/