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<p>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 (<i>n</i> = 547) or nivolumab 480 mg (<i>n</i> = 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; <i>P</i> = 0.928); therefore, overall survival was not tested. Translational data across trials showed lower circulating LAG-3<sup>+</sup> T cells in the adjuvant setting (RELATIVITY-098) versus advanced melanoma (RELATIVITY-047), where LAG-3<sup>+</sup> T cells were enriched in tumor versus blood. The absence of macroscopic tumor and reduced peripheral LAG-3<sup>+</sup> T cells may explain the lack of added benefit of nivolumab plus relatlimab over nivolumab in resected versus metastatic melanoma. ClinicalTrials.gov identifier: <a href="https://clinicaltrials.gov/study/NCT05002569">NCT05002569</a>.</p>

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Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月18日

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  • Georgina V. Long,
  • Charlie Garnett-Benson,
  • Sonia Dolfi,
  • Paolo A. Ascierto,
  • Jun Guo,
  • Ahmad A. Tarhini,
  • Sunandana Chandra,
  • Eva Muñoz-Couselo,
  • Michele Del Vecchio,
  • Andreia Cristina de Melo,
  • Margaret Callahan,
  • Helen Gogas,
  • Reinhard Dummer,
  • Dirk Schadendorf,
  • Peter Koelblinger,
  • Gaelle Quereux,
  • Ioannis Thomas,
  • Jia Xin Yu,
  • Andrew Fisher,
  • Bonnie Wang,
  • Patrick Djidel,
  • Armand Chouzy,
  • Mark Semaan,
  • Bohang Chen,
  • Alicia M. Y. Cheong,
  • Hussein A. Tawbi

摘要

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.