FDA Approves Pembrolizumab/Chemo in Platinum-Resistant GYN Indications

Pembrolizumab (keytruda) and pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) have been approved by the FDA in combination with paclitaxel with or without bevacizumab (Avastin) for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1, determined by an FDA-approved test, or who have 1 to 2 prior systemic therapies.

In tandem, the FDA approved the PD-L1 IHC 22C3 pharmDx companion diagnostic to determine patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who have tumors that express PD-L1 with a combined positive score of 1 or more.

The approval was based on results from the phase 3 KEYNOTE-B96 trial (NCT05116189), which showed a median progression-free survival (PFS) of 8.3 months (95% CI, 7.0-9.4) in the pembrolizumab arm vs 7.2 months (95% CI, 6.2-8.1) in the placebo arm (HR, 0.72; 95% CI, 0.58-0.89; P = .0014). Additionally, the median overall survival (OS) was 18.2 months (95% CI, 15.3-21.0) vs 14.0 months (95% CI, 12.5-16.1) between both arms, respectively (HR, 0.76; 95% CI, 0.61-0.94; P = .0053).

The recommended dose of pembrolizumab is 200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months on treatment. For pembrolizumab and berahyaluronidase alfa-pmph, the recommended dose is 395mg/4800 units every 3 weeks or 790mg/9600 units every 6 weeks. Bevaciziumab can be administered on the same day as pembrolizumab.

The safety of the regimen in the KEYNOTE-B96 trial was noted to be similar to previously reported results from other trials. The prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplant, and embryo-fetal toxicity.

Reference

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. News release. FDA. February 10, 2026. Accessed February 10, 2026. https://tinyurl.com/ydzhnzha