Journal Article

DKFZ-2025-01231

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Nivolumab plus relatlimab in advanced melanoma: RELATIVITY-047 4-year update.

Lipson, E. J. ; Stephen Hodi, F. ; Tawbi, H. ; Schadendorf, D.DKFZ* ; Ascierto, P. A. ; Matamala, L. ; Gutierrez, E. C. ; Rutkowski, P. ; Gogas, H. J. ; Lao, C. D. ; Menezes, J. J. D. ; Dalle, S. ; Arance, A. ; Gaudy-Marqueste, C. ; Chen, B. ; Jackson, W. ; Mukherjee, S. ; Dolfi, S. ; Long, G. V.

2025
Elsevier Amsterdam [u.a.]

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Please use a persistent id in citations: doi:10.1016/j.ejca.2025.115547

Abstract: In phase 2/3 randomized RELATIVITY-047, nivolumab plus relatlimab demonstrated a statistically significant improvement in progression-free survival (PFS), a clinically meaningful but not statistically significant improvement in overall survival (OS), and a numerically higher objective response rate (ORR) versus nivolumab alone in patients with previously untreated advanced melanoma.Descriptive 4-year updated analyses in patients treated with nivolumab 480 mg plus relatlimab 160 mg fixed-dose combination versus nivolumab 480 mg intravenously every 4 weeks are presented. Primary endpoint was PFS by blinded independent central review (BICR). Other endpoints included melanoma-specific survival (MSS).At 45.3 months' minimum follow-up, nivolumab plus relatlimab versus nivolumab PFS improvement was maintained: 4-year PFS rates were 30.6 % (95 % CI, 25.4-35.9) versus 23.6 % (95 % CI, 18.9-28.5); OS was numerically better with 4-year OS rates of 52.0 % (95 % CI, 46.6-57.1) versus 42.8 % (95 % CI, 37.5-47.9); and ORR difference was maintained at 43.9 % (95 % CI, 38.7-49.3) versus 33.4 % (95 % CI, 28.6-38.6), respectively. 4-year MSS rates were 59.7 % (95 % CI, 54.1-64.8) for nivolumab plus relatlimab and 49.6 % (95 % CI, 44.0-54.9) for nivolumab. Efficacy across the majority of prespecified subgroups favored the combination. No new or unexpected safety signals were identified.With 4 years of follow-up, nivolumab plus relatlimab demonstrated durable improvement in outcomes versus nivolumab monotherapy for patients with previously untreated advanced melanoma. The durable benefit observed comes at a lower toxicity cost compared with other immuno-oncology combinations.ClinicalTrials.gov Identifier: NCT03470922.

Keyword(s): Advanced melanoma ; Immunotherapy ; Long-term survival ; Nivolumab ; Relatlimab

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Contributing Institute(s):

1. DKTK Koordinierungsstelle Essen/Düsseldorf (ED01)

Research Program(s):

1. 899 - ohne Topic (POF4-899) (POF4-899)

Appears in the scientific report 2025

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Database coverage:
; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; Current Contents - Life Sciences ; Ebsco Academic Search ; Essential Science Indicators ; IF >= 5 ; JCR ; Nationallizenz ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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