The European Commission has approved Merck’s KEYTRUDA (pembrolizumab), 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 with a Combined Positive Score (CPS) ≥1 and who have received one or two prior systemic treatment regimens. The decision also covers the subcutaneous formulation KEYTRUDA SC (KEYTRUDA QLEX in the U.S.), making this the first PD-1 inhibitor–based treatment option for eligible platinum-resistant ovarian cancer patients in the European Union.
The approval is based on the Phase 3 KEYNOTE-B96 (ENGOT-ov65) trial, which showed that KEYTRUDA plus paclitaxel ± bevacizumab significantly improved progression-free survival (PFS) and overall survival (OS) versus placebo plus paclitaxel ± bevacizumab in patients with PD-L1–positive platinum-resistant recurrent ovarian cancer. In patients with PD-L1 CPS ≥1 tumors, the regimen reduced the risk of disease progression or death by 28% (HR=0.72; 95% CI, 0.58–0.89; p=0.0014), with median PFS of 8.3 months versus 7.2 months for the placebo regimen. The risk of death was reduced by 24% (HR=0.76; 95% CI, 0.61–0.94; p=0.0053), with median OS of 18.2 months versus 14.0 months.
The authorization applies across all 27 EU member states as well as Iceland, Liechtenstein and Norway; availability will depend on completion of national reimbursement processes. The regimen received a positive opinion from the EMA’s CHMP in February 2026 and follows a similar FDA approval in the U.S. for the same patient population earlier this year.
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