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Recently, the Journal of Clinical Oncology published the research results of the Phase II clinical study ALPHA (NCT03695510) carried out by a team in Taiwan, China, mainly to evaluate Afatinib (afatinib) combined with Pembrolizumab (pembrolizumab) in the treatment of recurrent or Outcomes in patients with metastatic head and neck squamous cell carcinoma (HNSCC)
.
.
The ALPHA (NCT03695510) study is a single-arm Phase II clinical study
.
Patients with platinum-refractory, relapsed, or metastatic HNSCC were mainly included
The ALPHA (NCT03695510) study is a single-arm Phase II clinical study
From January 2019 to March 2020, a total of 29 patients were included
The median progression-free survival (PFS) was 4.
All patients (100%) had at least one treatment-related toxic event, and 11 (37.
9%) patients had grade 3 or higher treatment-related toxic events
.
Common treatment-related adverse events were rash (75.
All patients (100%) had at least one treatment-related toxic event, and 11 (37.
Twenty-eight (96.
6%) patients had sufficient tissue samples for PD-L1 analysis
.
The ORR of patients with high PD-L1 expression was numerically higher than that of patients with low PD-L1 expression, but there was no statistical difference (PD-L1 TPS ≧50, ORR: 71% vs.
Twenty-eight (96.
In conclusion, the ALPHA study showed that afatinib can enhance the efficacy of pembrolizumab (pembrolizumab) and improve ORR in HNSCC patients
Original source:
Kao HF, Liao BC, Huang YL, Huang HC, Chen CN, Chen TC, Hong YJ, Chang CY, Chia JS, Hong RL.
Kao HF, Liao BC, Huang YL, Huang HC, Chen CN, Chen TC, Hong YJ, Chang CY, Chia JS, Hong RL.
Afatinib and Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (ALPHA Study): A Phase II Study with Biomarker Analysis.
Clin Cancer Res.
2022 Jan 19:clincanres.
3025.
2021.
doi: 10.
1158/1078-0432.
CCR-21-3025.
Epub ahead of print.
PMID: 35046059.
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