Improved Survival with Ipilimumab in Patients with Metastatic Melanoma

Wednesday August 18, 2010

According to the study abstract, “an improvement in overall survival among patients with metastatic melanoma has been an elusive goal”. In this phase 3 study, ipilimumab administered with or without a glycoprotein 100 (gp100) peptide vaccine was compared with gp100 alone in patients with previously treated metastatic melanoma.

The trial involved a total of 676 patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease. The patients were randomly assigned, in a 3:1:1 ratio, to receive ipilimumab plus gp100 (403 patients), ipilimumab alone (137), or gp100 alone (136). The primary end point was overall survival

According to the abstract, “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. The median overall survival with ipilimumab alone was 10.1 months. No difference in overall survival was detected between the ipilimumab groups. 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.”

The authors conclude that “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”.

Source: Hodi FS, O'Day SJ, McDermott DF, et al. Improved Survival with Ipilimumab in Patients with Metastatic Melanoma. N. Engl. J. Med. 14 June 2010.
http://www.nejm.org/doi/full/10.1056/NEJMoa1003466