Wednesday, August 18, 2010 (Last Updated: 08/19/2010)
WEDNESDAY, Aug. 18 (HealthDay News) -- Ipilimumab may improve survival in patients with previously treated metastatic melanoma, but with risk of severe adverse events, according to research published in the Aug. 19 issue of the New England Journal of Medicine.
F. Stephen Hodi, M.D., of the Dana-Farber Cancer Institute in Boston, and colleagues analyzed data from 676 patients with unresectable metastatic stage III or IV melanoma who had had progression while receiving therapy. Patients were randomized to receive ipilimumab alone or with a glycoprotein 100 (gp100) peptide vaccine, or gp100 alone.
The researchers found that the median overall survival was 10 months in patients receiving ipilimumab plus gp100, 10.1 months with ipilimumab alone, and 6.4 months with gp100 alone. There was no significant difference in overall survival between the ipilimumab groups. Ten to 15 percent of patients receiving ipilimumab -- and 3 percent receiving gp100 alone -- had grade 3 or 4 immune-related adverse events. Fourteen deaths were related to study drugs, with seven associated with immune-related adverse events.
"These results are especially important, since metastatic melanoma has historically been resistant to treatment. Although primary cutaneous melanoma is curable in its early stages with surgical resection, patients with metastatic melanoma have a median survival of less than one year," writes the author of an accompanying editorial.
The study was supported by Medarex and Bristol-Myers Squibb. Several co-authors disclosed financial relationships with these and/or other pharmaceutical companies.
Copyright © 2010 HealthDay. All rights reserved.