{
  "abstract": "Background Treatment-free survival (TFS; time spent free of systemic anticancer therapy) is increasingly used to support traditional endpoints. TFS was previously evaluated in patients with advanced melanoma treated with nivolumab plus ipilimumab. This analysis compared TFS for nivolumab plus relatlimab and nivolumab monotherapy in patients with advanced melanoma.Methods Data were from 714 patients in the phase 2/3 RELATIVITY-047 trial (ClinicalTrials.gov identifier: NCT03470922). TFS was defined as the difference in restricted mean event times between the Kaplan-Meier curves for time to protocol therapy cessation and time to subsequent systemic anticancer therapy initiation or death. TFS was further partitioned into time with and time without grade ≥3 treatment-related adverse events (TRAEs). Subgroup analysis based on tumor BRAF mutational status and tumor programmed death ligand 1 (PD-L1) expression level was conducted. Between-treatment group differences were calculated with bootstrapped 95% CIs.Results At 48 months from randomization, Kaplan-Meier estimates of overall survival were 52% and 43% for patients in the nivolumab plus relatlimab and nivolumab groups, respectively; 38% and 33% of patients in these respective groups were free of subsequent systemic therapy. The 48-month mean TFS was 2.9 months (95% CI 1.0 to 4.9) longer with nivolumab plus relatlimab than with nivolumab (9.7 vs 6.8 months, respectively). Mean TFS represented 20% and 14% of the 48-month period after initiating nivolumab plus relatlimab and nivolumab, respectively. Considering only time without grade ≥3 TRAEs, the 48-month mean TFS was 2.6 months (95% CI 0.8 to 4.5) longer with nivolumab plus relatlimab than with nivolumab (9.1 vs 6.5 months, respectively). The 48-month mean total TFS was consistently longer with nivolumab plus relatlimab than with nivolumab in the BRAF mutant (9.4 vs 6.5 months), BRAF wild-type (9.9 vs 6.9 months), PD-L1 ≥1% (12.3 vs 7.7 months), and PD-L1<1% (7.9 vs 6.2 months) subgroups.Conclusions This analysis demonstrated TFS benefit during the 48 months since initiating nivolumab plus relatlimab compared with nivolumab alone in patients with advanced melanoma. A direct comparison between nivolumab plus relatlimab and nivolumab plus ipilimumab is needed to determine the differences between the regimens in TFS and those in traditional endpoints.",
  "authors": [
    {
      "affiliations": [
        "Dana-Farber Cancer Institute, Boston, Massachusetts, USA"
      ],
      "name": "Meredith M Regan"
    },
    {
      "affiliations": [
        "Istituto Nazionale dei Tumori IRCCS “Fondazione G. Pascale”, Naples, Italy"
      ],
      "name": "Paolo A Ascierto MD"
    },
    {
      "affiliations": [
        "The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, Maryland, USA"
      ],
      "name": "Evan J Lipson"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, New Jersey, USA"
      ],
      "name": "Jennell Palaia"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, New Jersey, USA"
      ],
      "name": "Andriy Moshyk"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, New Jersey, USA"
      ],
      "name": "Abraham Selvan"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, New Jersey, USA"
      ],
      "name": "Christopher D Lao"
    },
    {
      "affiliations": [
        "Georgetown University Lombardi Comprehensive Cancer Center, Washington, District of Columbia, USA"
      ],
      "name": "Michael B Atkins MD"
    },
    {
      "affiliations": [
        "Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA"
      ],
      "name": "David F McDermott"
    },
    {
      "affiliations": [
        "Putnam Associates, New York, New York, USA"
      ],
      "name": "Ravi Potluri"
    },
    {
      "affiliations": [
        "Putnam Associates, Gurugram, Haryana, India"
      ],
      "name": "Sandip Ranjan"
    },
    {
      "affiliations": [
        "Putnam Associates, Gurugram, Haryana, India"
      ],
      "name": "Sandeep Bilthare"
    },
    {
      "affiliations": [
        "Melanoma Institute Australia, The University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia"
      ],
      "name": "Georgina V Long"
    },
    {
      "affiliations": [
        "Dana-Farber Cancer Institute, Boston, Massachusetts, USA"
      ],
      "name": "F Stephen Hodi"
    },
    {
      "affiliations": [
        "The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"
      ],
      "name": "Hussein Tawbi"
    },
    {
      "affiliations": [
        "University of Essen and the German Cancer Consortium, Essen, Germany",
        "National Center for Tumor Diseases, Essen, Germany",
        "and University Alliance Ruhr, University Duisburg-Essen, Essen, Germany"
      ],
      "name": "Dirk Schadendorf"
    }
  ],
  "title": "Analysis of treatment-free survival of patients with advanced melanoma receiving nivolumab as monotherapy or in combination with relatlimab in RELATIVITY-047",
  "uid": "171ee91f-6f37-5594-8f49-4947558c51e2"
}