FDA Approves Pembrolizumab Plus Paclitaxel for Platinum-Resistant Ovarian Cancer in the US
Key Clinical Summary
- The US Food and Drug Administration (FDA) approved pembrolizumab, with or without berahyaluronidase alfa-pmph, in combination with paclitaxel ± bevacizumab for adults with PD-L1–positive (CPS ≥1) platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after 1 or 2 prior systemic regimens.
- In KEYNOTE-B96 (n = 643), pembrolizumab improved progression-free survival (PFS) and overall survival (OS) vs placebo in the PD-L1 CPS ≥1 subgroup.
- PD-L1 IHC 22C3 pharmDx was approved as a companion diagnostic to identify eligible patients.
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 adults 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.
Main News
Efficacy was evaluated in KEYNOTE-B96 (NCT05116189), a multicenter, randomized, double-blind, placebo-controlled trial enrolling 643 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who had received 1 or 2 prior systemic regimens. All patients had radiographic disease progression within 6 months after their last platinum-based chemotherapy.
Patients were randomized 1:1 to pembrolizumab plus paclitaxel (with or without bevacizumab) or placebo plus paclitaxel (with or without bevacizumab). The primary endpoint was investigator-assessed PFS per RECIST v1.1, with OS as an additional efficacy endpoint.
Among the 466 patients with PD-L1 CPS ≥1 tumors, median PFS was 8.3 months (95% CI, 7.0-9.4) with pembrolizumab versus 7.2 months (95% CI, 6.2-8.1) with placebo (HR 0.72; 95% CI, 0.58-0.89; P = .0014). Median OS was 18.2 months (95% CI, 15.3-21.0) vs 14.0 months (95% CI, 12.5-16.1), respectively (HR 0.76; 95% CI, 0.61-0.94; P = .0053).
The safety profile of pembrolizumab combined with paclitaxel ± bevacizumab was consistent with prior experience in oncology. The prescribing information includes warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.
The FDA also approved PD-L1 IHC 22C3 pharmDx (Agilent Technologies) as a companion diagnostic to identify eligible PD-L1 CPS ≥1 tumors.
Clinical Implications
Platinum-resistant ovarian cancer remains a high-need setting with limited durable treatment options. The approval introduces an immunotherapy-based combination for patients with PD-L1 CPS ≥1 tumors after 1 or 2 prior systemic therapies.
The observed improvements in both PFS and OS in the PD-L1–positive population may support biomarker-driven treatment selection in this space. Clinicians should ensure PD-L1 testing using the FDA-authorized companion diagnostic to identify eligible patients.
Recommended dosing for pembrolizumab is 200 mg every 3 weeks or 400 mg every 6 weeks, administered prior to paclitaxel ± bevacizumab when given on the same day, for up to 24 months or until progression or unacceptable toxicity. The fixed-dose combination with berahyaluronidase alfa-pmph offers a subcutaneous option at specified intervals.
Conclusion
The FDA approval of pembrolizumab-based combination therapy for PD-L1–positive platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma adds an immunotherapy option supported by improvements in PFS and OS in KEYNOTE-B96. PD-L1 testing with the 22C3 companion diagnostic is required to guide patient selection.
Reference
FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. FDA.gov. Press release. Published on February 10, 2026. Accessed March 6, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
