The European Commission has approved Merck's KEYTRUDA (pembrolizumab) as part of a perioperative treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) expressing PD-L1 (CPS ≥1), marking the first and only anti-PD-1 option for this indication in the European Union. The decision is based on results from the pivotal Phase 3 KEYNOTE-689 trial, which demonstrated that the KEYTRUDA-based regimen yielded a statistically significant and clinically meaningful improvement in event-free survival (EFS) over standard adjuvant radiotherapy, with or without cisplatin, for patients whose tumors express PD-L1.
Specifically, the KEYTRUDA perioperative regimen reduced the risk of EFS events—including disease recurrence, progression, or death—by 30% compared to radiotherapy-based regimens alone. Median EFS was doubled to 59.7 months in the KEYTRUDA cohort versus 29.6 months in the comparator group, underscoring the therapy’s impact in providing long-term benefits to patients with this challenging subtype of cancer.
This approval is valid across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. KEYTRUDA is now approved as monotherapy for neoadjuvant treatment, continued as adjuvant treatment alongside radiotherapy (with or without cisplatin), and then as monotherapy in adults with resectable LA-HNSCC whose tumors express PD-L1. The development sets a new standard for immunotherapy in head and neck cancers, broadening treatment options and potentially improving patient outcomes.
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