A Diagnostic Test Enabling Precision Oncology in Head and Neck Cancer

Predicts Therapeutic Response to ICI and Anti-EGFR Antibody Treatments

Overview

For patients with platinum-sensitive recurrent or metastatic head and neck squamous cell carcinoma (R/M-HNSCC), first-line therapy usually involves pembrolizumab (an immune checkpoint inhibitor; ICI) with chemotherapy (5-FU plus cisplatin/carboplatin), or pembrolizumab alone for PD-L1–positive cases defined by the combined positive score (CPS). As a second-line option, cetuximab (anti-EGFR antibody) plus paclitaxel (CET+PTX) is commonly used. Our study revealed that responses to pembrolizumab plus chemotherapy and subsequent CET+PTX are inversely associated in R/M-HNSCC, and that activation of the JAK–STAT pathway, particularly STAT3 phosphorylation, marks tumors resistant to pembrolizumab-based therapy but sensitive to CET+PTX. This diagnostic approach uses these biomarkers to guide treatment sequencing after ICI.

Data

Application

These biomarkers enable identification of patients likely to respond to each therapy, supporting:
・prior selection of CET regimens,
・combination therapies with ICIs and anti-EGFR antibodies,
・combination therapies with ICIs and agents targeting the identified pathways.

Related Works

JCO Precis Oncol 10 e2501050(2026)

IP Data

IP No.　 ： JP2025-126227
Inventor ： SAIJO Ken,KAWAKAMI Hisato
keyword ： CDx, Cancer