KEYNOTE-048 — A Study of Pembrolizumab for First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Phase 3 · 2019 · Head and Neck Squamous Cell Carcinoma

Design

Three-arm trial of pembrolizumab monotherapy, pembrolizumab plus platinum-fluorouracil, or the EXTREME regimen (cetuximab plus platinum-fluorouracil).

Population

Untreated recurrent or metastatic head and neck squamous cell carcinoma, stratified by PD-L1 combined positive score (CPS).

Primary Endpoint

overall survival (OS) and progression-free survival (PFS)

Key Result

5-year follow-up: pembro+chemo OS HR 0.72 (total), 0.65 (CPS≥1), 0.63 (CPS≥20); pembro monotherapy HR 0.74 (CPS≥1), 0.61 (CPS≥20); 5-yr OS 16.0% (pembro-chemo) / 14.4% (pembro mono) vs ~6% (EXTREME).

Guideline Impact

NCCN category 1 first-line for recurrent/metastatic HNSCC