Afatinib and Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (ALPHA Study): A Phase II Study with Biomarker Analysis

Afatinib may augment pembrolizumab therapy and improve the ORR in HNSCC patients. The paired tissue analysis showed that afatinib, an epidermal growth factor (EGFR) tyrosine kinase inhibitor, may enhance antigen presentation, natural killer cell–mediated cytotoxicity, and immune reactions. We also identified unaltered methyl-thioadenosine phosphorylase (MTAP) levels, EGFR amplification, and high programmed death-ligand 1 expression as possible predictive biomarkers for therapeutic outcomes. A phase II, single arm study using pembrolizumab and afatinib for platinum-refractory head and neck squamous cell carcinoma patients. Pre-treatment and post-treatment biopsy were used for analysis.