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Association details:
| Biomarker: | EGFR amplification |
|---|---|
| Cancer: | Squamous Cell Carcinoma of Head and Neck |
| Drug: | Keytruda (pembrolizumab) (PD1 inhibitor) + Gilotrif (afatinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
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:
Source:
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:
05/19/2021
Excerpt:
Patients with high PD-L1 expression had a higher response rate (TPS > = 50: ORR = 0.71, CPS > = 20: ORR = 0.63). EGFR amplification might also predict a higher response rate (ORR: 3/3, 100%)...Afatinib can modify tumor microenvironment and increase the clinical response rate in pembrolizumab-based therapy in HNSCC patients.
DOI:
10.1200/JCO.2021.39.15_suppl.6024
Trial ID:
