Bristol-Myers Squibb Company (NYSE: BMY) today announced that a clinical trial — known as study 024 — of its investigational compound ipilimumab has met the primary endpoint of improving overall survival in previously-untreated patients with metastatic melanoma. Study 024 was designed to assess overall survival in unresectable stage III or stage IV melanoma patients who have not received prior therapy. The study compares ipilimumab 10mg/kg in combination with chemotherapy (dacarbazine) vs. chemotherapy alone. An abstract of the 024 data will be submitted to the American Society of Clinical Oncology for potential presentation at the Annual Meeting in June of this year.
A regulatory filing for ipilimumab, based on a study known as 020, is currently under review by the U.S. Food and Drug Administration and other health authorities worldwide. The filings are based on study 020, which assessed overall survival in previously-treated unresectable stage III or stage IV melanoma patients. Study 020 compared ipilimumab 3 mg/kg + gp100 vaccine vs. gp100 vaccine alone and ipilimumab along vs. gp100 vaccine alone. The PDUFA date for the U.S. filing is March 26, 2011.