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@ARTICLE{Ascierto:267569,
      author       = {P. A. Ascierto and E. J. Lipson and R. Dummer and J. Larkin
                      and G. V. Long and R. E. Sanborn and V. Chiarion-Sileni and
                      B. Dréno and S. Dalle and D. Schadendorf$^*$ and M. K.
                      Callahan and M. Nyakas and V. Atkinson and C. A. Gomez-Roca
                      and N. Yamazaki and H. A. Tawbi and N. Sarkis and D. Warad
                      and S. Dolfi and P. Mitra and S. Suryawanshi and J.-J. Grob},
      title        = {{N}ivolumab and {R}elatlimab in {P}atients {W}ith
                      {A}dvanced {M}elanoma {T}hat {H}ad {P}rogressed on
                      {A}nti-{P}rogrammed {D}eath-1/{P}rogrammed {D}eath {L}igand
                      1 {T}herapy: {R}esults {F}rom the {P}hase {I}/{II}a
                      {RELATIVITY}-020 {T}rial.},
      journal      = {Journal of clinical oncology},
      volume       = {41},
      number       = {15},
      issn         = {0732-183X},
      address      = {Alexandria, Va.},
      publisher    = {American Society of Clinical Oncology},
      reportid     = {DKFZ-2023-00347},
      pages        = {2724-2735},
      year         = {2023},
      note         = {2023 May 20;41(15):2724-2735},
      abstract     = {Nivolumab and relatlimab activity in advanced melanoma with
                      prior progression on anti-programmed death-1/programmed
                      death ligand 1 (PD-(L)1)-containing regimens is under
                      investigation. RELATIVITY-047 demonstrated significantly
                      improved progression-free survival (PFS) for nivolumab and
                      relatlimab over nivolumab in previously untreated advanced
                      melanoma.The phase I/IIa, open-label RELATIVITY-020 trial
                      part D assessed efficacy and safety of nivolumab and
                      relatlimab in advanced melanoma with progression during, or
                      within 3 months of, 1 (D1) or ≥ 1 (D2)
                      anti-PD-(L)1-containing regimens. Safety was a primary end
                      point. Objective response rate (coprimary end point) and PFS
                      by blinded independent central review (BICR) were
                      assessed.Five hundred eighteen patients (D1 = 354; D2 = 164)
                      received nivolumab and relatlimab. Among evaluable patients,
                      the objective response rate by BICR was $12.0\%$ $(95\%$ CI,
                      8.8 to 15.8) in D1 (n = 351) and $9.2\%$ $(95\%$ CI, 5.2 to
                      14.7) in D2 (n = 163). Responses appeared to be enriched
                      among patients with tumors expressing programmed death
                      ligand 1 or lymphocyte activation gene 3; however, responses
                      were observed regardless of programmed death ligand 1 and
                      lymphocyte activation gene 3 expression $(1\%).$ The median
                      duration of response was not reached $(95\%$ CI, 12.9 to not
                      reached) in D1 and 12.8 months $(95\%$ CI, 6.9 to 12.9) in
                      D2. The median PFS by BICR was 2.1 months $(95\%$ CI, 1.9 to
                      3.5) in D1 and 3.2 months $(95\%$ CI, 1.9 to 3.6) in D2; the
                      6-month PFS rate was $29.1\%$ $(95\%$ CI, 24.2 to 34.1) and
                      $27.7\%$ $(95\%$ CI, 20.5 to 35.4), respectively. The grade
                      3-4 treatment-related adverse event incidence was $15.0\%$
                      in D1 and $12.8\%$ in D2. One case of grade 3 myocarditis
                      and no treatment-related deaths occurred across part
                      D.Nivolumab and relatlimab had a manageable safety profile
                      and demonstrated durable clinical activity in a proportion
                      of patients with heavily pretreated advanced melanoma with
                      prior progression on anti-PD-(L)1-containing regimens.},
      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:36780608},
      doi          = {10.1200/JCO.22.02072},
      url          = {https://inrepo02.dkfz.de/record/267569},
}