Immunotherapy Drug Extends Survival in Metastatic Melanoma

For metastatic melanoma patients who were out of treatment options, the immune system-targeted drug ipilimumab extended their lives by nearly four months compared with an investigational vaccine called gp100.

The phase 3 study randomly assigned 676 patients with metastatic melanoma that had progressed during prior therapy to one of three arms: ipilimumab alone, gp100 alone, or ipilimumab plus gp100. In patients receiving ipilimumab alone, median overall survival reached 10.1 months, compared with 6.4 months for those receiving gp100 alone. Adding gp100 to ipilimumab didn’t improve survival, which was 10 months for the combination. Twenty-four percent of patients continued to benefit from ipilimumab for at least two years, compared with 14 percent for gp100.

“We’ve never had a drug show survival benefit in metastatic melanoma,” lead researcher Steven O’Day, MD, of The Angeles Clinic and Research Institute in Los Angeles, told CURE at the meeting. “It’s not only impacting median [survival], but it’s impacting long-term survival. And now we have patients on this trial out as far as four and a half years still alive.”

The most common side effect of ipilimumab was diarrhea, although up to 15 percent of patients experienced other severe side effects related to autoimmunity, such as rash and inflammation of the colon. Bristol-Myers Squibb, the maker of ipilimumab, plans to file the drug for approval in pretreated metastatic melanoma later this year.