Merck 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 tumours express PD-L1 with a Combined Positive Score (CPS) ≥1. This approval marks the first and only 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. 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 tumours expressing PD-L1 (CPS ≥1).

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.