Monday, June 7, 2010 (Last Updated: 06/08/2010)
MONDAY, June 7 (HealthDay News) -- In patients with previously treated metastatic melanoma, ipilimumab -- either alone or in combination with a glycoprotein 100 (gp100) peptide vaccine -- may significantly improve overall survival, according to a study published online June 5 in the New England Journal of Medicine to coincide with a presentation at the 46th Annual Meeting of the American Society of Clinical Oncology, held from June 4 to 8 in Chicago.
F. Stephen Hodi, M.D., of the Dana-Farber Cancer Institute in Boston, and colleagues conducted a phase 3 study in which 676 patients with unresectable stage III or IV melanoma that had progressed while they were being treated for metastatic disease were randomly assigned to receive either ipilimumab plus gp100, ipilimumab alone, or gp100 alone.
The researchers found that median overall survival was significantly improved in patients receiving ipilimumab plus gp100 or ipilimumab alone (10 and 10.1 months, respectively) compared to those receiving gp100 alone (6.4 months). In patients treated with ipilimumab, they found that the rate of grade 3 or 4 immune-related adverse events was 10 to 15 percent compared to a rate of 3 percent in those treated with gp100 alone, but concluded that most such events are reversible with appropriate treatment. They found that 14 deaths (2.1 percent) were related to the study drugs, including seven which were associated with immune-related adverse events.
"In some patients, side effects can be life-threatening and may be treatment-limiting," the authors conclude. "Reinduction with ipilimumab at the time of disease progression can result in further clinical benefit. Overall, our findings suggest that the T-cell potentiator ipilimumab may be useful as a treatment for patients with metastatic melanoma whose disease progressed while they were receiving one or more previous therapies."
The study was supported by Medarex and Bristol-Myers Squibb; several authors disclosed financial ties to the companies.
Hematology & Oncology
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