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Joyce F. Liu, MD, MPH
Joyce F. Liu, MD, MPH
Posted: Friday, October 24, 2025
The addition of pembrolizumab to weekly paclitaxel, with or without bevacizumab, resulted in statistically significant and clinically meaningful improvements in progression-free and overall survival in platinum-resistant recurrent ovarian cancer, according to a phase III trial presented at the European Society for Medical Oncology (ESMO) Congress 2025 (Abstract). The improvement in progression-free survival was seen in patients regardless of PD-L1 status, while the overall survival benefit was confined to those with a PD-L1 combined positive score of at least 1, noted Nicoletta Colombo, MD, PhD, of the University of Milan-Bicocca, Italy.
The double-blind, phase III ENGOT-ov65/KEYNOTE-B96 trial included a total of 643 patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who received one or two prior systemic regimens (≥ 1 platinum-based, ≥ 4 cycles in first line) and showed evidence of platinum-resistant disease. Patients were randomly assigned in a 1:1 ratio to receive 400 mg of intravenous pembrolizumab (n = 322) or placebo (n = 321) every 6 weeks plus weekly paclitaxel (80 mg/m2 on days 1, 8, and 15 of each 3-week cycle) with or without bevacizumab (10 mg/kg every 2 weeks).
At the first interim analysis (median follow-up = 15.6 months), pembrolizumab was found to significantly improve progression-free survival vs placebo in patients with a PD-L1 combined positive score of at least 1 (8.3 vs 7.2 months; hazard ratio [HR] = 0.72) and in the overall population (8.3 vs 6.4 months; HR = 0.70). Overall survival appeared to be significantly improved in those with a PD-L1 combined positive score of at least 1 (18.2 vs 14.0 months; HR = 0.76), with a favorable trend in the overall population (17.7 vs 14.0 months; HR = 0.81), based on the results of the second interim analysis (median follow-up = 26.6 months). Grade 3 or higher treatment-related adverse events were reported in 67.5% vs 55.3% of the patients treated with pembrolizumab vs placebo, respectively.
Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com.
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