Results from Pooled Analysis Reinforces Survival Benefit from Ipilimumab

F. Stephen Hodi, MD

F. Stephen Hodi, MD

Results from a pooled analysis of survival data from 12 studies demonstrated long-term survival benefit in patients with metastatic or locally advanced or unresectable melanoma treated with ipilimumab (Yervoy). The results were announced by Bristol-Myers Squibb Company on September 27 and were presented at the 2013 European Cancer Congress on September 28.

This study, which included 2 phase III trials, 8 phase II trials, and 2 retrospective trials, represents the largest OS analysis to date for patients with advanced melanoma treated with ipilimumab. The analysis also included both patients who were previously treated (n=1,257) and previously untreated (n=604).

“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 six to nine months,” said F. Stephen Hodi, MD, Department of Medicine, Harvard Medical School, Dana-Farber Cancer Institute, in a statement.

In the 1,861 patients treated with ipilimumab, median overall survival (OS) was 11.4 months (95% CI: 10.7—12.1). Researchers noted a distinct plateau in OS at year 3 that extended through year 10, independent of line of therapy, ipilimumab dose, or maintenance therapy. The 3-year OS rates were 22%, in the entire study population, 26% for treatment-naïve patients, and 20% for previously treated patients. The authors of the study wrote that these OS data should be considered as a benchmark for future melanoma therapies, as they represent a large benefit in a difficult-to-treat disease.

“This pooled analysis reinforces the long-term survival data seen in the individual studies and provides additional insight into the overall survival of metastatic melanoma patients treated with Yervoy,” said Brian Daniels, senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb Company, in a statement. “The durability and consistency of long-term survival observed in this analysis is encouraging as we continue to advance the research and development of our immuno-oncology portfolio.”

In each of the trials in the analysis, patients received ipilimumab at different doses, with the majority of patients receiving 3 mg/kg (n=965) or 10 mg/kg (n=706) every 3 or 4 weeks. Most of the studies provided the option for eligible patients to receive ipilimumab retreatment or ipilimumab maintenance therapy.

Safety data were not included in the analysis. Adverse events attributed to ipilimumab, which are typically mechanism (immune)-based, were managed in individual trials with protocol-specific guidelines, including dose interruption or discontinuation and the administration of systemic corticosteroids.

The FDA approved ipilimumab 3 mg/kg monotherapy in 2011 for patients with unresectable or metastatic melanoma. Ipilimumab is now approved in more than 40 countries.