A pooled analysis of 12 studies reinforces the long-term survival edge seen with Yervoy® (ipilimumab). Bristol-Myers Squibb Company’s Yervoy is a recombinant, human monoclonal antibody that blocks the cytotoxic T-lymphocyte-associated antigen-4. It was approved in 2011 for the treatment of metastatic or unresectable melanoma. The new findings were presented at the European Cancer Congress in Amsterdam.
In the analysis, 1,861 patients with metastatic or locally advanced or unresectable melanoma were treated with Yervoy at different doses and regimens. A plateau in the survival curve begins at approximately 3 years, with follow-up of up to 10 years in some patients. Approximately 22% of patients were alive at 3 years after being treated with an ipilimumab regimen.
“This pooled analysis is encouraging, particularly when considering that metastatic melanoma is one of the most aggressive forms of cancer and historically, average survival was just 6 to 9 months,” says F. Stephen Hodi, MD, of the Dana-Farber Cancer Institute in Boston, in a news release.
The analysis is comprised of patient-level data from 12 prospective and retrospective studies, including two Phase 3 trials, eight Phase 2 trials, and two retrospective, observational studies, which have been or will be reported on as individual studies. Three studies included overall survival follow-up in some patients for up to 10 years. It included both previously treated and previously untreated patients who received Yervoy at different doses and regimens. The majority of patients received Yervoy 3 mg/kg or 10 mg/kg. Yervoy was given every 3 weeks for four doses, and most studies included the option to receive either Yervoy retreatment or Yervoy maintenance therapy for eligible patients.
Safety data were not included in this analysis, but the types of adverse events attributed to Yervoy are generally mechanism-based.