% IMPORTANT: The following is UTF-8 encoded. This means that in the presence % of non-ASCII characters, it will not work with BibTeX 0.99 or older. % Instead, you should use an up-to-date BibTeX implementation like “bibtex8” or % “biber”. @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}, }