Exploratory Biomarker Analysis of Abemaciclib in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma With

Joo-Hwan Park1, Hee Kyung Ahn1,2, Hye Ryun Kim3

  • 1Division of Medical Oncology, Department of Internal Medicine, Gachon University School of Medicine, Gil Medical Center, Incheon, Republic of Korea.

Head & Neck
|January 13, 2026
PubMed
Abstract

Insights

In HPV-negative head and neck squamous cell carcinoma (HNSCC), CDKN2A deletion may predict longer disease stabilization with abemaciclib, despite limited overall efficacy. Further research is needed.

Area of Science:

  • Oncology
  • Molecular Biology
  • Genetics

Background:

  • HPV-negative head and neck squamous cell carcinoma (HNSCC) is characterized by cell cycle dysregulation, particularly CDK4/6 pathway activation.
  • Abemaciclib, a CDK4/6 inhibitor, is a potential therapeutic agent for this patient population.

Purpose of the Study:

  • To identify biomarkers that predict the efficacy of abemaciclib in patients with platinum-refractory HNSCC.
  • To evaluate the association between genetic alterations and clinical outcomes in patients treated with abemaciclib.

Main Methods:

  • A post hoc analysis of the TRIUMPH trial (NGS-based) compared genetic profiles of patients with long stable disease (SD; progression-free survival [PFS] > 6 months) versus short SD (PFS < 6 months).
  • In vitro studies assessed abemaciclib's antitumor effects on HNSCC cell lines.

Main Results:

  • Abemaciclib demonstrated limited efficacy in 23 patients, with a 0% overall response rate and 43.5% disease control rate.
  • CDKN2A deletion was significantly associated with longer SD (p=0.0078), whereas CCND1 amplification and CDKN2A mutation were not.
  • In vitro, HNSCC cell lines with CDKN2A deletion exhibited increased sensitivity to abemaciclib.

Conclusions:

  • CDKN2A deletion may serve as a predictive biomarker for prolonged disease stabilization in response to abemaciclib in HNSCC.
  • Further investigation is warranted in genomically selected populations and combination therapy strategies.