Nivolumab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in checkmate 141 by prior cetuximab use

Robert L. Ferris, Lisa Licitra, Jerome Fayette, Caroline Even, George Blumenschein, Kevin J. Harrington, Joel Guigay, Everett E. Vokes, Nabil F. Saba, Robert Haddad, Shanmugasundaram Ramkumar, Jeffery Russell, Peter Brossart, Makoto Tahara, A. Dimitrios Colevas, Fernando Concha-Benavente, Mark Lynch, Li Li, Maura L. Gillison

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: Cetuximab, which modulates immune responses, may affect the efficacy of subsequent immunotherapy. Here, we assessed outcomes with nivolumab, by prior cetuximab exposure, in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) who had experienced progression within 6 months of platinumcontaining chemotherapy. Patients and Methods: In the randomized, open-label, phase III CheckMate 141 trial, patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC) of single-agent chemotherapy, with stratification by prior cetuximab exposure. The primary endpoint was overall survival (OS); additional endpoints were progression- free survival, objective response rate, and safety. Results: In patients with prior cetuximab exposure, the median OS was 7.1 months with nivolumab versus 5.1 months with IC (HR, 0.84; 95% CI, 0.62-1.15); OS benefit with nivolumab was maintained across most demographic subgroups. In patients without prior cetuximab exposure, the median OS was 8.2 months with nivolumab versus 4.9 months with IC (HR, 0.52; 95% CI, 0.35-0.77); OS benefit with nivolumab was maintained across patient baseline subgroups including tumor programmed death ligand 1 (PD-L1) expression (<1% or ≥1%). Grade 3-4 treatment-related adverse event rates favored nivolumab versus IC in both subgroups. Conclusions: Nivolumab appeared to improve efficacy versus IC regardless of prior cetuximab use, supporting its use in patients with R/M SCCHN with or without prior cetuximab exposure. The reduction in risk of death with nivolumab compared with IC was greater in patients without prior cetuximab exposure versus with prior cetuximab exposure.

Original languageEnglish
Pages (from-to)5221-5230
Number of pages10
JournalClinical Cancer Research
Volume25
Issue number17
DOIs
Publication statusPublished - Sep 1 2019

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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