Improved survival with ipilimumab in patients with metastatic melanoma. [Erratum appears in N Engl J Med. 2010 Sep 23;363(13):1290]

F S Hodi, S J O'Day, D F McDermott, R W Weber, J A Sosman, J B Haanen, R Gonzalez, C Robert, D Schadendorf, J C Hassel, W Akerley, A J van den Eertwegh, J Lutzky, P Lorigan, J M Vaubel, G P Linette, D Hogg, C H Ottensmeier, C Lebbe, C PeschelI Quirt, J I Clark, J D Wolchok, J S Weber, J Tian, M J Yellin, G M Nichol, A Hoos, W J Urba

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: An improvement in overall survival among patients with metastatic melanoma has been an elusive goal. In this phase 3 study, ipilimumab--which blocks cytotoxic T-lymphocyte-associated antigen 4 to potentiate an antitumor T-cell response--administered with or without a glycoprotein 100 (gp100) peptide vaccine was compared with gp100 alone in patients with previously treated metastatic melanoma. METHODS: A total of 676 HLA-A*0201-positive patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease, were randomly assigned, in a 3:1:1 ratio, to receive ipilimumab plus gp100 (403 patients), ipilimumab alone (137), or gp100 alone (136). Ipilimumab, at a dose of 3 mg per kilogram of body weight, was administered with or without gp100 every 3 weeks for up to four treatments (induction). Eligible patients could receive reinduction therapy. The primary end point was overall survival. RESULTS: The median overall survival was 10.0 months among patients receiving ipilimumab plus gp100, as compared with 6.4 months among patients receiving gp100 alone (hazard ratio for death, 0.68; P
Original languageEnglish
Pages (from-to)711-723
Number of pages13
JournalNew England Journal Of Medicine
Volume363
Issue number8 PG - 711-23
Publication statusPublished - 2010

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