Document Type
Article
Publication Date
4-20-2023
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 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.
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.
Recommended Citation
Haddad, Robert I.; Harrington, Kevin; Tahara, Makoto; Ferris, Robert L.; Gillison, Maura; Fayette, Jerome; Daste, Amaury; Koralewski, Piotr; Zurawski, Bogdan; Taberna, Miren; Saba, Nabil F.; Mak, Milena; Kawecki, Andrzej; Girotto, Gustavo; Alvarez Avitia, Miguel Angel; Even, Caroline; Toledo, Joaquin Gabriel Reinoso; Guminski, Alexander; Müller-Richter, Urs; Kiyota, Naomi; Roberts, Mustimbo; Khan, Tariq Aziz; Miller-Moslin, Karen; Wei, Li; and Argiris, Athanassios, "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." (2023). Department of Medical Oncology Faculty Papers. Paper 236.
https://jdc.jefferson.edu/medoncfp/236
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
PubMed ID
36473143
Language
English
Comments
This article is the author’s final published version in Journal of Clinical Oncology, Volume 41, Issue 12, April 2023, Pages 2166 - 2180.
The published version is available at https://doi.org/10.1200/JCO.22.00332. Copyright © American Society of Clinical Oncology.