FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

Regulatory approval: On Feb 10, 2026, the FDA approved pembrolizumab (Keytruda) and pembrolizumab/berahyaluronidase alfa-pmph (Keytruda Qlex) with paclitaxel, with or without bevacizumab, for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors are PD-L1–positive (CPS≥1) by an FDA-authorized test and who received 1–2 prior systemic regimens. Approval was supported by KEYNOTE-B96, showing improved PFS and OS in PD-L1 CPS≥1 tumors versus placebo combination therapy.

FDA approval (Feb 10, 2026)

The US FDA approved pembrolizumab (Keytruda) and pembrolizumab/berahyaluronidase alfa-pmph (Keytruda Qlex) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received 1–2 prior systemic treatment regimens.

The FDA also approved PD-L1 IHC 22C3 pharmDx (Agilent) as a companion diagnostic to identify eligible patients (PD-L1 CPS≥1).

Supporting evidence: KEYNOTE-B96 (NCT05116189)

KEYNOTE-B96 was a multicenter, randomized, double-blind, placebo-controlled trial (n=643) in platinum-resistant disease after 1–2 prior lines; participants had received ≥1 prior platinum-based regimen and progressed radiographically within 6 months of last platinum dose. Patients were randomized 1:1 to pembrolizumab + paclitaxel ± bevacizumab vs placebo + paclitaxel ± bevacizumab.

In the PD-L1 CPS≥1 subgroup (n=466):

  • PFS (investigator-assessed RECIST v1.1): 8.3 vs 7.2 months (HR 0.72; 95% CI 0.58–0.89; p=0.0014)
  • OS: 18.2 vs 14.0 months (HR 0.76; 95% CI 0.61–0.94; p=0.0053)

Safety was described as consistent with prior pembrolizumab experience; labeling includes warnings/precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity. The review was conducted under Project Orbis; partner-agency decisions may still be pending.

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