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@ARTICLE{Long:305455,
author = {G. V. Long and C. Garnett-Benson and S. Dolfi and P. A.
Ascierto and J. Guo and A. A. Tarhini and S. Chandra and E.
Muñoz-Couselo and M. Del Vecchio and A. C. de Melo and M.
Callahan and H. Gogas and R. Dummer and D. Schadendorf$^*$
and P. Koelblinger and G. Quereux and I. Thomas and J. X. Yu
and A. Fisher and B. Wang and P. Djidel and A. Chouzy and M.
Semaan and B. Chen and A. M. Y. Cheong and H. A. Tawbi},
title = {{A}djuvant nivolumab and relatlimab in stage {III}/{IV}
melanoma: the randomized phase 3 {RELATIVITY}-098 trial.},
journal = {Nature medicine},
volume = {nn},
issn = {1078-8956},
address = {[New York, NY]},
publisher = {Springer Nature},
reportid = {DKFZ-2025-02173},
pages = {nn},
year = {2025},
note = {epub},
abstract = {Based on RELATIVITY-047, nivolumab plus relatlimab is
approved for advanced melanoma. Here, to address a current
unmet need for more efficacious adjuvant regimens for
completely resected melanoma, the phase 3, double-blind
RELATIVITY-098 trial compared adjuvant nivolumab plus
relatlimab to nivolumab after complete resection of stage
III/IV melanoma. Patients were randomized 1:1 to receive
nivolumab 480 mg plus relatlimab 160 mg (n = 547) or
nivolumab 480 mg (n = 546) intravenously every 4 weeks for
≤1 year; safety populations totaled 543 and 545 patients,
respectively. The primary endpoint was recurrence-free
survival (RFS), and the key secondary was overall survival;
translational endpoints were exploratory. There was no
difference in RFS for nivolumab plus relatlimab versus
nivolumab (hazard ratio = 1.01; $95\%$ confidence interval:
0.83-1.22; P = 0.928); therefore, overall survival was not
tested. Translational data across trials showed lower
circulating LAG-3+ T cells in the adjuvant setting
(RELATIVITY-098) versus advanced melanoma (RELATIVITY-047),
where LAG-3+ T cells were enriched in tumor versus blood.
The absence of macroscopic tumor and reduced peripheral
LAG-3+ T cells may explain the lack of added benefit of
nivolumab plus relatlimab over nivolumab in resected versus
metastatic melanoma. ClinicalTrials.gov identifier:
NCT05002569 .},
cin = {ED01},
ddc = {610},
cid = {I:(DE-He78)ED01-20160331},
pnm = {899 - ohne Topic (POF4-899)},
pid = {G:(DE-HGF)POF4-899},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:41109920},
doi = {10.1038/s41591-025-04032-8},
url = {https://inrepo02.dkfz.de/record/305455},
}