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FDA approves pembrolizumab with chemotherapy for platinum-resistant recurrent ovarian cancer

On February 10, 2026, the U.S. Food and Drug Administration (FDA) approved pembrolizumab with paclitaxel for PD-L1-expressing platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.1 Patients with platinum-resistant ovarian cancer (PROC), defined by progression within six months of platinum-based chemotherapy, face poor outcomes, limited durability of response, and a lack of clearly effective standards of care.2

The approval is based on results from the randomized, double-blind Phase III ENGOT-ov65/KEYNOTE-B96 trial (NCT05116189), which assessed pembrolizumab plus weekly paclitaxel, with or without bevacizumab in patients with PROC, who have progressed on 1-2 prior systemic regimens. The primary and secondary endpoints were investigator-assessed progression-free survival (PFS) and overall survival (OS) respectively.3

In the first interim analysis, the primary endpoint was met at a median follow-up of 15.6 months, where PFS was 8.3 months in the pembrolizumab arm versus 6.4 months in the placebo arm in the overall population (95% CI: 0.58–0.84). Pembrolizumab additionally benefited patients with PD-L1-positive tumors (PD-L1 combined positive score [CPS] ≥1),  where PFS was 8.3 and 7.2 months in the respective arms (95% CI: 0.58–0.89). In the first interim analysis, OS was 8.2 months versus 14.0 months (95% CI: 0.61–0.94) in the PD-L1 CPS ≥1 population at a medial follow-up of 26.6 months, demonstrating a significant improvement in the pembrolizumab arm. The safety profile of the combination was generally consistent with the known effects of chemotherapy, bevacizumab, and immune checkpoint inhibition.3

Collectively, these results signal a potential shift in the treatment paradigm for platinum-resistant ovarian cancer. By demonstrating both progression-free and overall survival benefits, the approval of pembrolizumab offers a new therapeutic direction for patients with limited options and historically poor outcomes. This approach will redefine expectations for disease control and survival in a population long characterized by unmet need.

References:

  1. Center for Drug Evaluation and Research. FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma  [Internet]. U.S. Food and Drug Administration. 2025 [cited 2026 Feb 10]. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
  2. Li H, Sheng J-J, Zheng S-A, Liu P-W, Wu N, Zeng W-J, et al. Platinum-resistant ovarian cancer: From mechanisms to treatment strategies. Genes & Diseases. 2025 Mar;13(2):101801
  3. Colombo N, Zsiros E, Sebastianelli A, Bidzinski M, Araneda CEG, Matanes E, et al. LBA3 Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: Results from the randomized double-blind phase III ENGOT-ov65/KEYNOTE-B96 study. Annals of Oncology. 2025 Sep;36:S1582.

Written by Sol Yohannes