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 - 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.
UR - http://www.scopus.com/inward/record.url?scp=85152622391&partnerID=8YFLogxK
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 -