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Updated: Jan 28, 2026

A Model for Perineural Invasion in Head and Neck Squamous Cell Carcinoma
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Clinical Outcomes of Pembrolizumab in Head and Neck Squamous Cell Carcinoma Subsites Excluded from the KEYNOTE-048

Gai Yamashita1, Takuro Okada1, Isaku Okamoto1

  • 1Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo 160-0023, Japan.

Current Oncology (Toronto, Ont.)
|January 27, 2026
PubMed

Insights

Pembrolizumab shows promise for head and neck squamous cell carcinoma in rare sites. This study found similar survival and safety outcomes compared to major sites, suggesting broader applicability of this immunotherapy.

Area of Science:

  • Oncology
  • Immunotherapy
  • Head and Neck Cancer Research

Background:

  • Recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) has a poor prognosis.
  • Immune checkpoint inhibitors, like pembrolizumab, are vital treatments.
  • KEYNOTE-048 excluded certain head and neck subsites, leaving outcomes in these areas unclear.

Purpose of the Study:

  • To evaluate the efficacy and safety of pembrolizumab in R/M SCCHN patients with tumors in subsites excluded from the KEYNOTE-048 trial.
  • To compare outcomes in these excluded subsites with those in major sites.

Main Methods:

  • A multicenter retrospective study of 167 R/M SCCHN patients treated with pembrolizumab.
  • Analysis of outcomes including overall survival (OS), progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR), and immune-related adverse events (irAEs).
  • Comparison between patients with tumors in excluded subsites (n=27) and included sites (n=127).

Main Results:

  • In the excluded subsite group: median OS was 15.2 months, median PFS was 4.9 months.
  • Overall response rate (ORR) was 22.2%, and disease control rate (DCR) was 59.3%.
  • The incidence of irAEs was 25.9%, with 3.7% being Grade ≥ 3. Survival outcomes were comparable to included sites.

Conclusions:

  • Pembrolizumab demonstrates potential efficacy and a manageable safety profile in R/M SCCHN patients with tumors in subsites like the paranasal sinuses and nasopharynx.
  • These findings support the use of pembrolizumab in these previously excluded populations.
  • Further validation in prospective clinical trials is warranted.
Keywords:
KEYNOTE-048excluded subsitespembrolizumabrecurrent or metastatic squamous cell carcinoma of the head and neck

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