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Association details:
Evidence:
Evidence Level:
Resistant: C3 – Early Trials
Title:

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

Published date:
04/14/2022
Excerpt:
The ALPHA study (NCT03695510) was a single-arm, Phase II study with Simon's 2-stage design. Afatinib and pembrolizumab were administered to patients with platinum-refractory, recurrent, or metastatic HNSCC....EGFR amplification predicted a higher response rate (EGFR amplification, n = 3; ORR, 100%, Fisher exact test, P = 0.07). Methylthioadenosine phosphorylase (MTAP) loss or mutation predicted a lower response rate (MTAP loss or mutation, n = 5; ORR, 0%, Fisher exact test, P = 0.046)....Afatinib may augment pembrolizumab therapy and improve the ORR in patients with HNSCC.
DOI:
10.1158/1078-0432.CCR-21-3025
Trial ID: