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<p>Despite receiving standard treatments, patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) often still face significant risks of disease recurrence or metastasis. In this phase II neoCHANCE-1 study (NCT05517330), we evaluated the efficacy and safety of the dual-targeted blockade of the PD-1 and EGFR pathways in a neoadjuvant setting. The primary endpoint was the major pathological response (MPR) rate. The secondary endpoints included the pathological complete response (pCR) rate, overall response rate (ORR), safety, disease-free survival (DFS), and overall survival (OS). A cohort of 25 patients was subjected to a treatment regimen consisting of tislelizumab for two cycles, concomitant with daily intake of afatinib for six weeks. Among the 23 evaluable patients, eight (35%; 95% CI, 16%–57%) achieved an MPR that met the prespecified endpoint, and four (17%, 95% CI, 5%–39%) achieved a pCR of the primary tumor. The ORR was 48% (12/25, 95% CI: 28%–69%). The most common grade 3–4 adverse events included diarrhea&#xa0;(5/25), hypokalemia&#xa0;(4/25), and rash&#xa0;(3/25). This study highlights the encouraging antitumor activity, manageable toxicity profile, and promising immune activation caused by neoadjuvant tislelizumab plus afatinib treatment of HNSCC, which deserves further investigation.</p>

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Neoadjuvant tislelizumab with afatinib for locally advanced head and neck squamous cell carcinoma (neoCHANCE-1): a phase 2 clinical trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月7日

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  • Zhi-gong Wei,
  • Hui-jiao Chen,
  • De-juan Wang,
  • Zheng Jiang,
  • Yi-yan Pei,
  • Le-yu Li,
  • Feng Wang,
  • Jing Jin,
  • Zhe-ran Liu,
  • Fei Chen,
  • Jun Liu,
  • Xing-chen Peng

摘要

Despite receiving standard treatments, patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) often still face significant risks of disease recurrence or metastasis. In this phase II neoCHANCE-1 study (NCT05517330), we evaluated the efficacy and safety of the dual-targeted blockade of the PD-1 and EGFR pathways in a neoadjuvant setting. The primary endpoint was the major pathological response (MPR) rate. The secondary endpoints included the pathological complete response (pCR) rate, overall response rate (ORR), safety, disease-free survival (DFS), and overall survival (OS). A cohort of 25 patients was subjected to a treatment regimen consisting of tislelizumab for two cycles, concomitant with daily intake of afatinib for six weeks. Among the 23 evaluable patients, eight (35%; 95% CI, 16%–57%) achieved an MPR that met the prespecified endpoint, and four (17%, 95% CI, 5%–39%) achieved a pCR of the primary tumor. The ORR was 48% (12/25, 95% CI: 28%–69%). The most common grade 3–4 adverse events included diarrhea (5/25), hypokalemia (4/25), and rash (3/25). This study highlights the encouraging antitumor activity, manageable toxicity profile, and promising immune activation caused by neoadjuvant tislelizumab plus afatinib treatment of HNSCC, which deserves further investigation.