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Updated: Sep 12, 2025

Intramucosal Inoculation of Squamous Cell Carcinoma Cells in Mice for Tumor Immune Profiling and Treatment Response Assessment
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Inflammation and limited adaptive immunity predict worse outcomes on immunotherapy in head and neck cancer

Lisa Paschold1, Christoph Schultheiss2,3, Paul Schmidt-Barbo2,3,4

  • 1Department of Internal Medicine IV, Oncology/Hematology, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.

NPJ Precision Oncology
|August 5, 2025
PubMed

Insights

Biomarkers in blood, not PD-L1, predict immunotherapy response in head and neck cancer. High inflammation markers indicate poor outcomes, while their absence predicts success with pembrolizumab.

Area of Science:

  • Oncology
  • Immunotherapy
  • Biomarker Discovery

Background:

  • Relapsed or metastatic head and neck squamous cell carcinoma (rmHNSCC) patients often lack durable responses to PD-1 inhibitors.
  • PD-L1 expression is an unreliable biomarker for predicting treatment outcomes in rmHNSCC.

Purpose of the Study:

  • To identify reliable blood- and tissue-based biomarkers for predicting response to PD-1 immune checkpoint inhibitors in rmHNSCC.
  • To stratify patients for more effective immunotherapy strategies.

Main Methods:

  • Analysis of the FOCUS trial cohort (NCT05075122) using various blood- and tissue-based markers.
  • Correlation of biomarker levels with clinical outcomes in patients receiving PD-1 inhibitors.

Main Results:

  • Tumor PD-L1 levels did not correlate with treatment benefit.
  • Increased inflammation markers (IL-6, sCD25, sTIM-3), high peripheral neutrophils, cell-free DNA, and T cell receptor clonality were associated with poor outcomes.
  • Patients without these high-risk markers showed significant benefit from pembrolizumab.

Conclusions:

  • Inflammation-related blood biomarkers, not PD-L1, are key predictors of immunotherapy response in rmHNSCC.
  • Biomarker-guided selection can personalize pembrolizumab therapy or inform novel combinatorial approaches for immune-impaired patients.

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