Improved Survival with Ipilimumab in Patients with Metastatic Melanoma.
AuthorsHodi, F Stephen
McDermott, David F
Weber, Robert W
Sosman, Jeffrey A
Haanen, John B
Hassel, Jessica C
van den Eertwegh, Alfons J M
Lorigan, Paul C
Vaubel, Julia M
Linette, Gerald P
Ottensmeier, Christian H
Clark, Joseph I
Wolchok, Jedd D
Weber, Jeffrey S
Yellin, Michael J
Nichol, Geoffrey M
Urba, Walter J
AffiliationDana-Farber Cancer Institute, Boston, MA 02115, USA.
MetadataShow full item record
AbstractBACKGROUND: 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<0.001). The median overall survival with ipilimumab alone was 10.1 months (hazard ratio for death in the comparison with gp100 alone, 0.66; P=0.003). No difference in overall survival was detected between the ipilimumab groups (hazard ratio with ipilimumab plus gp100, 1.04; P=0.76). Grade 3 or 4 immune-related adverse events occurred in 10 to 15% of patients treated with ipilimumab and in 3% treated with gp100 alone. There were 14 deaths related to the study drugs (2.1%), and 7 were associated with immune-related adverse events. CONCLUSIONS: Ipilimumab, with or without a gp100 peptide vaccine, as compared with gp100 alone, improved overall survival in patients with previously treated metastatic melanoma. Adverse events can be severe, long-lasting, or both, but most are reversible with appropriate treatment. (ClinicalTrials.gov number, NCT00094653.) Copyright 2010 Massachusetts Medical Society.
CitationImproved Survival with Ipilimumab in Patients with Metastatic Melanoma. 2010: N Engl J Med
JournalThe New England Journal of Medicine
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