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

Authors

Robert I Haddad
Kevin Harrington
Makoto Tahara
Robert L Ferris
Maura Gillison
Jerome Fayette
Amaury Daste
Piotr Koralewski
Bogdan Zurawski
Miren Taberna
Nabil F Saba
Milena Mak
Andrzej Kawecki
Gustavo Girotto
Miguel Angel Alvarez Avitia
Caroline Even
Joaquin Gabriel Reinoso Toledo
Alexander Guminski
Urs Müller-Richter
Naomi Kiyota
Mustimbo Roberts
Tariq Aziz Khan
Karen Miller-Moslin
Li Wei
Athanassios Argiris

Publication Date

4-20-2023

Journal

Journal of Clinical Oncology

Abstract

PURPOSE: CheckMate 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).

METHODS: Patients 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.

RESULTS: Among 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

CONCLUSION: CheckMate 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.

Keywords

Humans, Nivolumab, Ipilimumab, Cetuximab, Squamous Cell Carcinoma of Head and Neck, Antineoplastic Agents, Immunological, Neoplasm Recurrence, Local, Carcinoma, Squamous Cell, Head and Neck Neoplasms, Antineoplastic Combined Chemotherapy Protocols

DOI

10.1200/JCO.22.00332

PMID

36473143

PMCID

PMC10115555

PubMedCentral® Posted Date

December 2022

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes