Ipilimumab approved for metastatic melanoma

Today the FDA approved Yervoy (ipilimumab) for patients with metastatic melanoma. Yervoy, a monoclonal antibody, binds to and disables CTLA-4, a naturally occurring molecule that diminishes the immune response. (You can read the FDA release here.) The drug made headlines at a medical meeting this past summer when a phase 3 study revealed Yervoy improves survival in metastatic melanoma patients. (You can view the subsequent New England Journal of Medicine paper here.) The clinical trial enrolled 676 patients with metastatic melanoma that had progressed during prior therapy. Because there are few options for metastatic melanoma, the drug was compared with another investigational treatment that has shown promise, a vaccine called gp100. Patients were randomized to one of three arms: Yervoy alone, gp100 alone or Yervoy plus gp100. Researchers presenting the study results at the annual meeting of the American Society of Clinical Oncology found that in patients receiving Yervoy alone, median overall survival reached 10.1 months compared with 6.4 months for those receiving only the vaccine. Adding gp100 to Yervoy didn't improve survival, which was 10 months for the combination. Twenty-four percent of patients continued to benefit from Yervoy 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 during ASCO. "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 reported with the drug was diarrhea, although up to 15 percent of patients experienced other severe side effects related to autoimmunity, such as rash and colon inflammation. This marks a huge milestone in melanoma research. CURE will be reporting on Yervoy and other advances in melanoma in the upcoming Summer issue, so stay tuned!