TY - JOUR
T1 - Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
T2 - The Final Results of CheckMate 651
AU - Haddad, Robert I.
AU - Harrington, Kevin
AU - Tahara, Makoto
AU - Ferris, Robert L.
AU - Gillison, Maura
AU - Fayette, Jerome
AU - Daste, Amaury
AU - Koralewski, Piotr
AU - Zurawski, Bogdan
AU - Taberna, Miren
AU - Saba, Nabil F.
AU - Mak, Milena
AU - Kawecki, Andrzej
AU - Girotto, Gustavo
AU - Alvarez Avitia, Miguel Angel
AU - Even, Caroline
AU - Toledo, Joaquin Gabriel Reinoso
AU - Guminski, Alexander
AU - Müller-Richter, Urs
AU - Kiyota, Naomi
AU - Roberts, Mustimbo
AU - Khan, Tariq Aziz
AU - Miller-Moslin, Karen
AU - Wei, Li
AU - Argiris, Athanassios
N1 - Funding Information:
The authors thank the patients, their families, and the clinical study teams for making this study possible. We thank Dako for collaborative development of the PD-L1 IHC 28-8 pharmDx assay, and Bristol Myers Squibb (Princeton, NJ) and Ono Pharmaceutical Company Ltd (Osaka, Japan). The authors wish to acknowledge Bryan Bennett and Anagha Gogate for the PRO analysis. Writing and editorial assistance were provided by Meenakshi Subramanian, PhD, CMPP, of Evidence Scientific Solutions, Inc, funded by Bristol Myers Squibb.
Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/4/20
Y1 - 2023/4/20
N2 - 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.
AB - 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.
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U2 - 10.1200/JCO.22.00332
DO - 10.1200/JCO.22.00332
M3 - Article
C2 - 36473143
AN - SCOPUS:85152622391
SN - 0732-183X
VL - 41
SP - 2166
EP - 2180
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 12
ER -