dc.contributor.author | Larkin, J | |
dc.contributor.author | Del Vecchio, M | |
dc.contributor.author | Mandala, M | |
dc.contributor.author | Gogas, H | |
dc.contributor.author | Arance, AM | |
dc.contributor.author | Dalle, S | |
dc.contributor.author | Cowey, CL | |
dc.contributor.author | Schenker, M | |
dc.contributor.author | Grob, J-J | |
dc.contributor.author | Chiarion-Sileni, V | |
dc.contributor.author | Marquez-Rodas, I | |
dc.contributor.author | Butler, MO | |
dc.contributor.author | Di Giacomo, AM | |
dc.contributor.author | Middleton, MR | |
dc.contributor.author | Lutzky, J | |
dc.contributor.author | de la Cruz-Merino, L | |
dc.contributor.author | Arenberger, P | |
dc.contributor.author | Atkinson, V | |
dc.contributor.author | Hill, AG | |
dc.contributor.author | Fecher, LA | |
dc.contributor.author | Millward, M | |
dc.contributor.author | Nathan, PD | |
dc.contributor.author | Khushalani, NI | |
dc.contributor.author | Queirolo, P | |
dc.contributor.author | Ritchings, C | |
dc.contributor.author | Lobo, M | |
dc.contributor.author | Askelson, M | |
dc.contributor.author | Tang, H | |
dc.contributor.author | Dolfi, S | |
dc.contributor.author | Ascierto, PA | |
dc.contributor.author | Weber, J | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2023-07-07T10:52:49Z | |
dc.date.available | 2023-07-07T10:52:49Z | |
dc.date.issued | 2023-04-14 | |
dc.identifier | 725906 | |
dc.identifier.citation | Clinical Cancer Research, 2023, pp. CCR-22-3145 - | en_US |
dc.identifier.issn | 1078-0432 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5881 | |
dc.identifier.eissn | 1557-3265 | |
dc.identifier.eissn | 1557-3265 | |
dc.identifier.doi | 10.1158/1078-0432.CCR-22-3145 | |
dc.description.abstract | PURPOSE: In the phase III CheckMate 238 study, adjuvant nivolumab (NIVO) significantly improved recurrence-free survival (RFS) and distant metastasis-free survival versus ipilimumab (IPI) in patients with resected stage IIIB-C or stage IV melanoma, with benefit sustained at 4 years. We report updated 5-year efficacy and biomarker findings. PATIENTS AND METHODS: Patients with resected stage IIIB-C/IV melanoma were stratified by stage and baseline PD-L1 expression and received NIVO 3 mg/kg every 2 weeks or IPI 10 mg/kg every 3 weeks for four doses and then every 12 weeks, both intravenously for 1 year until disease recurrence, unacceptable toxicity, or withdrawal of consent. The primary endpoint was RFS. RESULTS: At a minimum follow-up of 62 months, RFS with NIVO remained superior to IPI (HR 0.72; 95% CI, 0.60-0.86; 5-year rates of 50% versus 39%). 5-year DMFS rates were 58% with NIVO versus 51% with IPI. Five-year OS rates were 76% with NIVO and 72% with IPI (75% data maturity: 228 of 302 planned events). Higher levels of TMB, tumor PD-L1, intratumoral CD8+ T cells and interferon-gamma-associated gene expression signature, and lower levels of peripheral serum C-reactive protein were associated with improved RFS and OS with both NIVO and IPI, albeit with limited clinically meaningful predictive value. CONCLUSION: NIVO is a proven adjuvant treatment for resected melanoma at high-risk of recurrence, with sustained, long-term improvement in RFS and DMFS compared with IPI and high OS rates. Identification of additional biomarkers are needed to better predict treatment outcome. | |
dc.format | Print-Electronic | |
dc.format.extent | CCR-22-3145 - | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | American Association for Cancer Research (AACR) | en_US |
dc.relation.ispartof | Clinical Cancer Research | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | en_US |
dc.title | Adjuvant Nivolumab Versus Ipilimumab in Resected Stage III/IV Melanoma: 5-Year Efficacy and Biomarker Results From CheckMate 238. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2023-04-12 | |
dc.date.updated | 2023-07-07T10:52:03Z | |
rioxxterms.version | AM | en_US |
rioxxterms.versionofrecord | 10.1158/1078-0432.CCR-22-3145 | en_US |
rioxxterms.licenseref.startdate | 2023-04-14 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/37058595 | |
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/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.) | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1158/1078-0432.ccr-22-3145 | |
dc.contributor.icrauthor | Larkin, James | |
icr.provenance | Deposited by Mr Arek Surman (impersonating Dr Doug Brand) on 2023-07-07. Deposit type is initial. No. of files: 1. Files: ccr-22-3145.pdf | |