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news.Bristol-Myers Squibb Company has announced that a clinical trial of its investigational compound ipilimumab has met the primary endpoint of improving overall survival in previously-untreated patients with metastatic melanoma.
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The study was designed to evaluate the overall survival in unresectable stage III or stage IV melanoma patients who have not received prior therapy.
The study compared ipilimumab 10mg/kg in combination with chemotherapy (dacarbazine) versus chemotherapy alone.
A regulatory filing for ipilimumab, based on a study known as 020, is currently under review by the US Food and Drug Administration and other health authorities around the world.
Study 020 assessed the overall survival in previously-treated unresectable stage III or stage IV melanoma patients, and it compared ipilimumab 3 mg/kg + gp100 vaccine, gp100 vaccine alone + ipilimumab alone, and gp100 vaccine alone.