Bristol-Myers Reveals Melanoma Survival Results From Pooled Analysis Of Yervoy

(RTTNews) - Bristol-Myers Squibb Co. (BMY) Friday revealed results from a pooled analysis of survival data for 12 studies in patients with metastatic or locally advanced or unresectable melanoma who were treated with Yervoy (ipilimumab).

According to the company, a plateau in the survival curve begins at about three years, with follow-up of up to ten years in some patients. About 22% of patients were alive at three years.

"In this analysis, approximately 26% of treatment-naïve and 20% of previously-treated patients were alive at three years after being treated with an ipilimumab regimen," said Stephen Hodi, Department of Medicine, Harvard Medical School, Dana-Farber Cancer Institute.

Bristol said that safety data were not included in the analysis. However, safety data from individual studies have been reported. Overall, the types of adverse events attributed to Yervoy are generally mechanism (immune)-based. Yervoy can result in severe and fatal immune-related adverse reactions due to T-cell activation and proliferation.

"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 said the data will be presented at the 2013 European Cancer Congress on September 28.

The pooled analysis was conducted to provide a more precise estimate of the long-term survival effect of Yervoy in patients with metastatic melanoma. It is comprised of patient-level data from 12 prospective and retrospective studies, including two Phase 3 trials and eight Phase 2 trials. Three studies included overall survival follow-up in some patients for up to ten years.

The analysis included both previously-treated (n=1,257) and previously untreated patients (n=604) who received Yervoy at different doses and regimens.

The majority of patients received Yervoy 3 mg/kg (n=965) or 10 mg/kg (n=706). Yervoy was given every 3 weeks for 4 doses, and most studies included the option to receive either Yervoy retreatment or Yervoy maintenance therapy for eligible patients.

Yervoy, which is a recombinant, human monoclonal antibody, blocks the cytotoxic T- lymphocyte-associated antigen-4 (CTLA-4). On March 25, 2011, the FDA approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 40 countries.