Biophys. Acta 1793, 625635 Preusser-Kunze, A., Mariappan, M., Schmidt, B., Gande, S. L.

May 11, 2024

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NIH Public AccessAuthor ManuscriptN Engl J Med. Author manuscript; readily available in PMC 2013 January 19.Published in final edited kind as: N Engl J Med. 2010 August 19; 363(eight): 71123. doi:ten.1056/NEJMoa1003466.Enhanced Survival with Ipilimumab in Sufferers with Metastatic Melanomawatermark-text watermark-text watermark-textF. Stephen Hodi, M.D., Steven J. O’Day, M.D., David F. McDermott, M.D., Robert W. Weber, M.D., Jeffrey A. Sosman, M.D., John B. Haanen, M.D., Rene Gonzalez, M.D., Caroline Robert, M.D., Ph.D., Dirk Schadendorf, M.D., Jessica C. Hassel, M.D., Wallace Akerley, M.D., Alfons J.M. van den Eertwegh, M.D., Ph.D., Jose Lutzky, M.D., Paul Lorigan, M.D., Julia M. Vaubel, M.D., Gerald P. Linette, M.D., Ph.D., David Hogg, M.D., Christian H. Ottensmeier, M.D., Ph.D., Celeste Lebb M.D., Christian Peschel, M.D., Ian Quirt, M.D., Joseph I. Clark, M.D., Jedd D. Wolchok, M.D., Ph.D., Jeffrey S. Weber, M.D., Ph.D., Jason Tian, Ph.D., Michael J. Yellin, M.D., Geoffrey M. Nichol, M.B., Ch.B., Axel Hoos, M.D., Ph.D., and Walter J. Urba, M.D., Ph.D. The authors’ affiliations and participating investigators are listed inside the AppendixAbstractBACKGROUND–An improvement in all round survival among sufferers with metastatic melanoma has been an elusive target. Within this phase 3 study, ipilimumab — which blocks cytotoxic T-lymphocyte ssociated antigen four to potentiate an antitumor T-cell response — administered with or with no a glycoprotein one hundred (gp100) peptide vaccine was compared with gp100 alone in patients with previously treated metastatic melanoma. METHODS–A total of 676 HLA-A0201 ositive individuals with unresectable stage III or IV melanoma, whose illness had progressed although they were getting therapy for metastatic illness, were randomly assigned, within a 3:1:1 ratio, to get ipilimumab plus gp100 (403 individuals), ipilimumab alone (137), or gp100 alone (136).Dehydroabietic acid Autophagy Ipilimumab, at a dose of three mg per kilogram of physique weight, was administered with or without the need of gp100 each three weeks for up to four treatment options (induction).PMID:24856309 Eligible individuals could get reinduction therapy. The key finish point was overall survival. RESULTS–The median general survival was ten.0 months among sufferers receiving ipilimumab plus gp100, as compared with 6.4 months amongst patients getting gp100 alone (hazard ratio for death, 0.68; P0.001). The median general survival with ipilimumab alone was 10.1 months (hazard ratio for death within the comparison with gp100 alone, 0.66; P = 0.003). No difference in general surviv.