TY - JOUR
T1 - Three-Year Overall Survival with Nivolumab Plus Relatlimab in Advanced Melanoma from RELATIVITY-047
AU - Tawbi, Hussein A.
AU - Hodi, F. Stephen
AU - Lipson, Evan J.
AU - Schadendorf, Dirk
AU - Ascierto, Paolo A.
AU - Matamala, Luis
AU - Castillo Gutiérrez, Erika
AU - Rutkowski, Piotr
AU - Gogas, Helen
AU - Lao, Christopher D.
AU - Janoski De Menezes, Juliana
AU - Dalle, Stéphane
AU - Arance, Ana Maria
AU - Grob, Jean Jacques
AU - Ratto, Barbara
AU - Rodriguez, Saima
AU - Mazzei, Antonella
AU - Dolfi, Sonia
AU - Long, Georgina V.
N1 - Publisher Copyright:
© 2024 American Society of Clinical Oncology.
PY - 2024
Y1 - 2024
N2 - 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.
AB - 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.
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U2 - 10.1200/JCO.24.01124
DO - 10.1200/JCO.24.01124
M3 - Article
C2 - 39671533
AN - SCOPUS:85212836758
SN - 0732-183X
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
M1 - JCO.24.01124
ER -