A recent study appears to have identified a drug that promises to dramatically improve survival rates in melanoma patients. Ahead, however, lies the Food and Drug Administration (FDA) approval process and still more research on what some are already hailing as a wonder drug: ipilimumab.
Los Angeles - A recent study appears to have identified a drug that promises to dramatically improve survival rates in melanoma patients.
Ahead, however, lies the Food and Drug Administration (FDA) approval process and still more research on what some are already hailing as a wonder drug: ipilimumab.
Doctor view early reports as significant. Ipilimumab extended the lives of patients with advanced melanoma by an average of nearly four months in late-stage testing.
Ipilimumab was co-developed by Medarex, which was acquired last year by Bristol-Myers Squibb, the study's funding source. The study itself was headed by Steven O'Day, M.D., director of the melanoma program at the Angeles Clinic and Research Institute, here, and Stephen Hodi, M.D., assistant professor of medicine at Harvard's Dana-Farber Cancer Institute.
The research involved 676 patients who had already been treated for advanced, inoperable melanoma. They received either ipilimumab by itself; ipilimumab combined with another immune-stimulating treatment; or the immune-stimulating treatment by itself. There was no maintenance phase, and the primary endpoint was overall survival.
Results show that after two years, 24 percent of those given ipilimumab alone or in combination were alive. Of those who received only the immune-stimulating treatment, 14 percent were still alive. The average survival period was 10 months with ipilimumab, compared with six months for the others - a 67 percent improvement for those treated with the drug.
Dr. O'Day calls the study's findings historic.
"This is the first randomized study to show improved survival benefits in late-stage clinical testing," he tells Dermatology Times. "Median survival improved from six months to just over 10 months, and, just as significantly, long-term follow-up showed double the survival rate for the ipilimumab patients."
Dr. O'Day, who is a consultant for Bristol-Myers Squib, says currently there are only two FDA-approved drugs for treating melanoma: the chemotherapy DTIC and interleukin-2.
"Those therapies are applicable only to a small subset of patients, among whom an even smaller subset benefit," Dr. Halpern notes.