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

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

Nature Communications, 2025, vol. 16, issue 1, 1-14

Abstract: Abstract 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.

Date: 2025
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DOI: 10.1038/s41467-025-63978-y

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