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Clin Cancer Res: Pembrolizumab combined with Acalabrutinib in the treatment of recurrent/metastatic head and neck squamous cell carcinoma

 Last Update: 2021-12-24
 Source: Internet
 Author: User

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Programmed cell death-1 (PD-1) receptor inhibitors have shown superior efficacy in head and neck squamous cell carcinoma (HNSCC), but most patients will have treatment failure or secondary drug resistance

This study is a multi-center, open-label, randomized phase 2 clinical trial to evaluate the effectiveness and safety of anti-PD-1 monoclonal antibody pembrolizumab combined with BTK inhibitor Acalabrutinib in the treatment of relapsed or metastatic HNSCC Sex

The test patients received pembrolizumab (200 mg, intravenously) with or without Acalabrutinib (100 mg×2/day, orally) every 3 weeks

A total of 76 patients were recruited: 39 in the pembrolizumab group and 37 in the pembrolizumab+Acalabrutinib group

The incidence of side effects (AE) requiring emergency treatment for grade 3-4 in the combination group and the single-agent group was 65% vs 39%, and the incidence of serious AEs was 68% vs 31%, respectively

Progression-free survival

The median PFS of the combination group and the single-agent group were 2.

Overall survival

In order to evaluate how the tumor immune environment is affected by the treatment in patients who underwent biopsy before and after treatment, the researchers performed spatial proteomics analysis (single-agent group, n=5; combination group, n=2).

immunity

In summary, although there is a lack of clinical efficacy, the analysis of immune subgroups shows that this combination scheme has an additive effect

Immune subgroup analysis shows that this combination scheme has an additive effect.

Original source:

Taylor Matthew H,Betts Courtney B,Maloney Lauren et al.

Safety and Efficacy of Pembrolizumab in Combination With Acalabrutinib in Advanced Head and Neck Squamous Cell Carcinoma: Phase 2 Proof-of-Concept Study

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