FDA approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma
Executive Summary
First approval for HNSCC in 6 years and the first overall perioperative approval for locally advanced HNSCC.
Efficacy was evaluated in KEYNOTE-689 (NCT03765918), a randomized, multicenter, open-label trial in 714 patients with resectable locally advanced (Stage III-IVA) HNSCC [AJCC, 8th edition].
For patients whose tumors express PD-L1 CPS ≥1 (n=682), median EFS was 59.7 months (95% CI: 37.9, not reached [NR]) in the pembrolizumab arm and 29.6 months (95% CI: 19.5, 41.9) in the control arm (hazard ratio 0.70 [95% CI: 0.55, 0.89]; p-value 0.00140).
For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada, and Switzerland’s Swissmedic under Project Orbis.
