dc.contributor.author | Haddad, RI | |
dc.contributor.author | Harrington, K | |
dc.contributor.author | Tahara, M | |
dc.contributor.author | Ferris, RL | |
dc.contributor.author | Gillison, M | |
dc.contributor.author | Fayette, J | |
dc.contributor.author | Daste, A | |
dc.contributor.author | Koralewski, P | |
dc.contributor.author | Zurawski, B | |
dc.contributor.author | Taberna, M | |
dc.contributor.author | Saba, NF | |
dc.contributor.author | Mak, M | |
dc.contributor.author | Kawecki, A | |
dc.contributor.author | Girotto, G | |
dc.contributor.author | Alvarez Avitia, MA | |
dc.contributor.author | Even, C | |
dc.contributor.author | Toledo, JGR | |
dc.contributor.author | Guminski, A | |
dc.contributor.author | Müller-Richter, U | |
dc.contributor.author | Kiyota, N | |
dc.contributor.author | Roberts, M | |
dc.contributor.author | Khan, TA | |
dc.contributor.author | Miller-Moslin, K | |
dc.contributor.author | Wei, L | |
dc.contributor.author | Argiris, A | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2023-03-03T13:10:05Z | |
dc.date.available | 2023-03-03T13:10:05Z | |
dc.date.issued | 2023-04-20 | |
dc.identifier.citation | Journal of Clinical Oncology, 2022, pp. JCO2200332 - | |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5705 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/JCO.22.00332 | |
dc.description.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. | |
dc.format | Print-Electronic | |
dc.format.extent | JCO2200332 - | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | |
dc.relation.ispartof | Journal of Clinical Oncology | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.title | 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. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2022-09-26 | |
dc.date.updated | 2023-03-03T13:09:03Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1200/JCO.22.00332 | |
rioxxterms.licenseref.startdate | 2022-12-06 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/36473143 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Cancer Biology | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Cancer Biology/Targeted Therapy | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Targeted Therapy | |
pubs.organisational-group | /ICR/ImmNet | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1200/jco.22.00332 | |
icr.researchteam | Targeted Therapy | |
dc.contributor.icrauthor | Harrington, Kevin | |
icr.provenance | Deposited by Mr Arek Surman on 2023-03-03. Deposit type is initial. No. of files: 1. Files: jco.22.00332.pdf | |