On February 10, 2026, the FDA approved pembrolizumab (Keytruda) and pembrolizumab with berahyaluronidase alfa-pmph (Keytruda Qlex) in combination with paclitaxel, with or without bevacizumab, for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumors express PD-L1 (CPS≥1) and who have received 1 or 2 prior systemic treatments.1 In addition, the FDA approved the PD-L1 IHC 22C3 pharmDx as a companion diagnostic device to identify eligible patients.
Efficacy was demonstrated in the KEYNOTE-B96 trial, which enrolled 643 patients randomized to either pembrolizumab plus paclitaxel with or without bevacizumab or placebo plus paclitaxel with or without bevacizumab. Patients treated with pembrolizumab showed a significant improvement in progression-free survival (PFS) (8.3 months vs 7.2 months; hazard ratio [HR], 0.72; P=.0014) and overall survival (OS) (18.2 months vs 14.0 months; HR, 0.76; P=.0053) compared with placebo.
The safety profile was consistent with prior trials, with warnings for immune-mediated adverse reactions, infusion-related reactions, and embryo-fetal toxicity. The recommended pembrolizumab dose is 200 mg every 3 weeks or 400 mg every 6 weeks, while Keytruda Qlex is dosed at 395 mg/4800 units every 3 weeks or 790 mg/9600 units every 6 weeks.
Reference
- FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or