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@ARTICLE{Regan:304582,
      author       = {M. M. Regan and P. A. Ascierto and E. J. Lipson and J.
                      Palaia and A. Moshyk and A. Selvan and C. D. Lao and M. B.
                      Atkins and D. F. McDermott and R. Potluri and S. Ranjan and
                      S. Bilthare and G. V. Long and F. Stephen Hodi and H. Tawbi
                      and D. Schadendorf$^*$},
      title        = {{A}nalysis of treatment-free survival of patients with
                      advanced melanoma receiving nivolumab as monotherapy or in
                      combination with relatlimab in {RELATIVITY}-047.},
      journal      = {Journal for ImmunoTherapy of Cancer},
      volume       = {13},
      number       = {9},
      issn         = {2051-1426},
      address      = {London},
      publisher    = {BioMed Central},
      reportid     = {DKFZ-2025-01905},
      pages        = {e012747},
      year         = {2025},
      abstract     = {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.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.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.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.},
      keywords     = {Immune Checkpoint Inhibitor (Other) / Immunotherapy (Other)
                      / Skin Cancer (Other)},
      cin          = {ED01},
      ddc          = {610},
      cid          = {I:(DE-He78)ED01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:40940136},
      doi          = {10.1136/jitc-2025-012747},
      url          = {https://inrepo02.dkfz.de/record/304582},
}