Three-Year Overall Survival With Nivolumab Plus Relatlimab in Advanced Melanoma From RELATIVITY-047
Nivolumab plus relatlimab demonstrated a statistically significant improvement in progression-free survival (PFS), along with a clinically meaningful, but not statistically significant improvement in overall survival (OS) and a numerically higher objective response rate (ORR) compared with nivolumab in the RELATIVITY-047 trial (ClinicalTrials.gov identifier: NCT03470922). We report updated descriptive efficacy and safety results from RELATIVITY-047 with a median follow-up of 33.8 months. Median PFS was 10.2 months (95% CI, 6.5 to 15.4) with nivolumab plus relatlimab and 4.6 months (95% CI, 3.5 to 6.5) with nivolumab (hazard ratio [HR], 0.79 [95% CI, 0.66 to 0.95]); median OS was 51.0 months (95% CI, 34.0 to not reached) and 34.1 (95% CI, 25.2 to 44.7) months, respectively (HR, 0.80 [95% CI, 0.66 to 0.99]). ORR was 43.7% (95% CI, 38.4 to 49.0) with nivolumab plus relatlimab and 33.7% (95% CI, 28.8 to 38.9) with nivolumab. Efficacy across the majority of prespecified subgroups favored the combination. No new or unexpected safety signals were identified. Overall, at 3-year follow-up, the benefit observed with nivolumab plus relatlimab compared with nivolumab in patients with advanced melanoma was sustained, with the OS HR 95% CI upper bound now <1. This benefit is accompanied by a safety profile consistent with previous reports.
Authors
- Hussein A. Tawbi (ORCID: https://orcid.org/0000-0003-1942-851X)
- Sonia Dolfi (ORCID: https://orcid.org/0000-0001-9454-4583)
- Ana Arance (ORCID: https://orcid.org/0000-0003-2896-1957)
- Evan J. Lipson (ORCID: https://orcid.org/0000-0003-2976-0911)
- Paolo A. Ascierto (ORCID: https://orcid.org/0000-0002-8322-475X)
- Dirk Schadendorf (ORCID: https://orcid.org/0000-0003-3524-7858)
- Antonella Mazzei (ORCID: https://orcid.org/0000-0003-2531-4252)
- Barbara Ratto
- Jean‐Jacques Grob (ORCID: https://orcid.org/0000-0002-0667-153X)
- Erika Castillo Gutiérrez (ORCID: https://orcid.org/0000-0002-5872-8497)
- Luis Matamala
- Georgina Venetia Long (ORCID: https://orcid.org/0000-0001-8894-3545)
- Saima Rodriguez
- Stéphane Dalle (ORCID: https://orcid.org/0000-0002-3423-4548)
- Piotr Rutkowski (ORCID: https://orcid.org/0000-0002-8920-5429)
- F. Stephen Hodi (ORCID: https://orcid.org/0000-0001-6825-091X)
- Helen J Gogas (ORCID: https://orcid.org/0000-0002-0451-2885)
- Christopher D. Lao
- J. Menezes (ORCID: https://orcid.org/0000-0002-5981-2324)
Institutions
- The University of Sydney (AU)
- Bloomberg (United States) (US)
- The University of Texas MD Anderson Cancer Center (US)
- Johns Hopkins University (US)
- National and Kapodistrian University of Athens (GR)
- Aix-Marseille Université (FR)
- Johns Hopkins Medicine (US)
- Bristol-Myers Squibb (United States) (US)
- Hospices Civils de Lyon (FR)
- Michigan Medicine (US)
- Hospital Clínic de Barcelona (ES)
- Hospital Nossa Senhora da Conceição (BR)
- Dana-Farber Cancer Institute (US)
- Melanoma Institute Australia (AU)
- Centre de Recherche en Cancérologie de Lyon (FR)
- Fundación Arturo López Pérez (CL)
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
- The Maria Sklodowska-Curie National Research Institute of Oncology (PL)
- Consorci Institut D'Investigacions Biomediques August Pi I Sunyer (ES)
- Sidney Kimmel Comprehensive Cancer Center (US)
- Deutsches Konsortium für Translationale Krebsforschung (DE)
Publication Details
- Journal
- Journal of Clinical Oncology
- Published
- 2024-12-13
- DOI
- https://doi.org/10.1200/jco.24.01124
- Citations
- 53
- Primary Topic
- CAR-T cell therapy research
- Type
- article
- Field-Weighted Citation Impact
- 14.97
Funders
- Bristol-Myers Squibb