Merck Keytruda wins European Commission nod for locally advanced head, neck squamous cell carcinoma
Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the European Commission (EC) has approved KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1.
This approval marks the anti-PD-1 treatment option for certain patients with resectable LA-HNSCC in the European Union (EU) and the third approval for KEYTRUDA in HNSCC in the EU.
“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 EC approval is based on results from the pivotal Phase 3 KEYNOTE-689 trial. At the trial’s first pre-specified interim analysis, the KEYTRUDA-based perioperative regimen demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the study’s primary endpoint, compared to adjuvant radiotherapy (with or without cisplatin) alone in patients with tumors expressing PD-L1 (CPS ≥1). The KEYTRUDA-based perioperative regimen reduced the risk of EFS events (defined as disease recurrence, disease progression or death) by 30% (HR=0.70 [95% CI, 0.55-0.89]; p=0.00140) in patients with tumors expressing PD-L1 (CPS ≥1) compared to adjuvant radiotherapy (with or without cisplatin) alone. Among the patients with tumors expressing PD-L1 (CPS ≥1), median EFS was doubled to 59.7 months (95% CI, 37.9-not reached) in the KEYTRUDA arm versus 29.6 months (95% CI, 19.5-41.9) in the comparator arm. The approval follows the positive recommendation from the Committee for Medicinal Products for Human Use received in September 2025.
This approval allows marketing of this KEYTRUDA treatment regimen for this indication in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Timing for commercial availability of KEYTRUDA for this indication in individual EU countries will depend on multiple factors, including the completion of national reimbursement procedures.
In June 2025, KEYTRUDA was approved in the U.S. for the treatment of adult patients with resectable LA-HNSCC whose tumors express PD-L1 (CPS ≥1) as determined by a U.S. Food and Drug Administration (FDA)-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin and then as a single agent. Based on the results from the Phase 3 KEYNOTE-689 trial KEYTRUDA was also approved in Canada, Brazil, Switzerland and several other countries around the globe as a perioperative treatment option for certain patients with resectable LA-HNSCC.
