Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age

Nabil F. Saba, George Blumenschein, Joel Guigay, Lisa Licitra, Jerome Fayette, Kevin J. Harrington, N. Kiyota, Maura L. Gillison, Robert L. Ferris, Vijayvel Jayaprakash, Li Li, P. Brossart

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: Many patients with squamous cell carcinoma of the head and neck (SCCHN) are ≥65 years old; comorbidities and other age-related factors may affect their ability to tolerate traditional chemotherapy. Nivolumab is the only immunotherapy to significantly improve overall survival (OS) versus investigator's choice (IC) of single-agent chemotherapy at primary analysis in a phase 3 trial (CheckMate 141) in patients with recurrent/metastatic SCCHN post-platinum therapy. In this post hoc analysis, we report efficacy and safety by age. Patients and methods: Eligible patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks (n = 240) or IC (methotrexate, docetaxel, or cetuximab n = 121). The primary endpoint of the trial was OS. For this analysis, outcomes were analyzed by age < 65 and ≥65 years. The data cut-off date was September 2017 (minimum follow-up 24.2 months). Results: At baseline, 68 patients (28.3%) receiving nivolumab and 45 patients (37.2%) receiving IC were ≥65 years. Baseline characteristics were generally similar across age groups. OS and tumor response benefits with nivolumab versus IC were maintained regardless of age. The 30-month OS rates of 11.2% (<65 years) and 13.0% (≥65 years) with nivolumab were more than tripled versus corresponding IC rates of 1.4% and 3.3%, respectively. The nivolumab arm had a lower rate of treatment-related adverse events versus IC regardless of age, consistent with the overall patient population. Conclusion: In CheckMate 141, nivolumab resulted in a higher survival versus IC in patients <65 and ≥65 years, with a manageable safety profile in both age groups. ClinicalTrials.gov: NCT02105636.

Original languageEnglish
Pages (from-to)7-14
Number of pages8
JournalOral Oncology
Volume96
DOIs
Publication statusPublished - Sep 2019

Keywords

  • Age
  • Biomarkers
  • Nivolumab
  • Phase 3 clinical trial
  • Squamous cell carcinoma of the head and neck

ASJC Scopus subject areas

  • Oral Surgery
  • Oncology
  • Cancer Research

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