Merck (known as MSD outside the U.S. and Canada) announced that the European Commission (EC) has approved Keytruda® (pembrolizumab), its anti–PD-1 therapy, as monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The treatment is approved as a neoadjuvant therapy, followed by adjuvant therapy in combination with radiation (with or without cisplatin), and then continued as monotherapy in adults whose tumours express PD-L1 with a Combined Positive Score (CPS) ≥1.
This marks the first and only anti–PD-1 treatment option for certain patients with resectable LA-HNSCC in the European Union, and the third EU approval for Keytruda in head and neck cancers.
“This approval brings a promising advancement to patients in Europe with resectable locally advanced head and neck squamous cell carcinoma,” said Dr. Marjorie Green, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. “We’re proud of the continued progress we’re making to broaden the impact of Keytruda in head and neck cancers and remain focused on working to deliver innovative approaches that have the potential to make a meaningful difference for patients.”
The approval is based on data from the Phase 3 KEYNOTE-689 trial, which evaluated Keytruda as perioperative therapy. The Keytruda-based regimen showed a statistically significant and clinically meaningful improvement in event-free survival (EFS) compared to adjuvant radiotherapy (with or without cisplatin) alone in patients with PD-L1 CPS ≥ 1. The regimen reduced the risk of EFS events by 30% (HR = 0.70 [95% CI, 0.55–0.89]; p = 0.0014) and doubled median EFS to 59.7 months versus 29.6 months in the comparator arm.
This EC decision applies to all 27 EU member states, as well as Iceland, Liechtenstein, and Norway, with national availability to follow upon reimbursement procedures. The approval follows FDA authorization in June 2025 for the same indication in the U.S., and subsequent approvals in Canada, Brazil, Switzerland, and other regions.
KEYNOTE-689, a randomized Phase 3 study involving 714 patients, demonstrated that perioperative Keytruda significantly improves clinical outcomes in resectable LA-HNSCC. The study evaluated Keytruda both before surgery (neoadjuvant) and after surgery (adjuvant) in combination with radiotherapy, with or without cisplatin.
Head and neck cancers account for over 947,000 new cases and 482,000 deaths worldwide annually. In Europe alone, about 161,900 cases and 72,500 deaths were reported in 2022. Most are squamous cell carcinomas, often linked to tobacco, alcohol use, or HPV infection.
Keytruda, a humanized monoclonal antibody, blocks PD-1 interaction with PD-L1 and PD-L2, enhancing immune system activity against tumour cells. Supported by over 1,600 ongoing trials across 30+ tumour types, Merck continues to expand Keytruda’s role in earlier-stage cancers and strengthen its leadership in immuno-oncology research.
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