Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651

• Type of Material: Article
• Authors: Robert I Haddad, Harvard Medical School; Kevin Harrington, Royal Marsden Hospital/The Institute of Cancer Research NIHR Biomedical Research Centre; Makoto Tahara, National Cancer Center Hospital East, Kashiwa, Japan; Roberto L Ferris, UPMC Hillman Cancer Center, Pittsburgh, PA; Maura Gillison, The University of Texas MD Anderson Cancer Center, Houston, TX; Jerome Fayette, Centre Léon Bérard, Lyon, France; Amaury Daste, Hôpital Saint-André, Bordeaux, France; Piotr Koralewski, Wojewodzki Szpital Specjalist; Bogdan Zurawski, Ambulatorium Chemioterapii; Miren Taberna, Catalan Institute of Oncology, L'Hospitalet de Llobregat, Barcelona, Spain; Nabil Saba, Emory University; Milena Mak, Universidade de São Paulo, São Paulo, Brazil; Andrzej Kawecki, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland; Gustavo Girotto, Hospital de Base de Sao Jose do Rio Preto, Sao Jose do Rio Preto; Miguel Angel Alvarez Avitia, Instituto Nacional De Cancerologíaa; Caroline Even, Gustave Roussy, Villejuif, France; Joaquin Gabriel Reinoso Toledo, The Research Unit, Monterrey, Nuevo Leon, Mexico; Alexander Guminski, Royal North Shore Hospital, Sydney, Australia; Urs Müller-Richter, University Hospital Würzburg; Naomi Kiyota, Kobe University Hospital, Kobe, Japan; Mustimbo Roberts, Bristol Myers Squibb, Princeton, NJ; Tariq A Khan, Bristol Myers Squibb, Princeton, NJ; Karen Miller-Moslin, Bristol Myers Squibb, Princeton, NJ; Li Wei, Bristol Myers Squibb, Princeton, NJ; Athanassios Argiris, Hygeia Hospital, Marousi, Greece
• Language: English
• Date: 2023-04-20
• Publisher: LIPPINCOTT WILLIAMS & WILKINS
• Publication Version: Final Published Version
• Copyright Statement: © 2022 by American Society of Clinical Oncology
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1200/JCO.22.00332
• Title of Journal or Parent Work: JOURNAL OF CLINICAL ONCOLOGY
• Volume: 41
• Issue: 12
• Start Page: 2166
• End Page: +
• Keywords: CHEMOTHERAPY; Life Sciences & Biomedicine; Science & Technology; RECURRENT; Oncology; MULTICENTER; OPEN-LABEL; METASTATIC HEAD; CETUXIMAB; PLATINUM
• Research Categories: Health Sciences, Oncology

Abstract

PURPOSECheckMate 651 (ClinicalTrials.gov identifier: NCT02741570) evaluated first-line nivolumab plus ipilimumab versus EXTREME (cetuximab plus cisplatin/carboplatin plus fluorouracil six cycles, then cetuximab maintenance) in recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).METHODSPatients without prior systemic therapy for R/M SCCHN were randomly assigned 1:1 to nivolumab plus ipilimumab or EXTREME. Primary end points were overall survival (OS) in the all randomly assigned and programmed death-ligand 1 combined positive score (CPS) 20 populations. Secondary end points included OS in the programmed death-ligand 1 CPS 1 population, and progression-free survival, objective response rate, and duration of response in the all randomly assigned and CPS 20 populations.RESULTSAmong 947 patients randomly assigned, 38.3% had CPS 20. There were no statistically significant differences in OS with nivolumab plus ipilimumab versus EXTREME in the all randomly assigned (median: 13.9 v 13.5 months; hazard ratio [HR], 0.95; 97.9% CI, 0.80 to 1.13; P =.4951) and CPS 20 (median: 17.6 v 14.6 months; HR, 0.78; 97.51% CI, 0.59 to 1.03; P =.0469) populations. In patients with CPS 1, the median OS was 15.7 versus 13.2 months (HR, 0.82; 95% CI, 0.69 to 0.97). Among patients with CPS 20, the median progression-free survival was 5.4 months (nivolumab plus ipilimumab) versus 7.0 months (EXTREME), objective response rate was 34.1% versus 36.0%, and median duration of response was 32.6 versus 7.0 months. Grade 3/4 treatment-related adverse events occurred in 28.2% of patients treated with nivolumab plus ipilimumab versus 70.7% treated with EXTREME.CONCLUSIONCheckMate 651 did not meet its primary end points of OS in the all randomly assigned or CPS 20 populations. Nivolumab plus ipilimumab showed a favorable safety profile compared with EXTREME. There continues to be a need for new therapies in patients with R/M SCCHN.