Bristol-Myers Squibb has announced that ipilimumab, an investigational compound, has met the primary endpoint of a clinical trial by improving the overall survival of previously untreated patients with a metastatic melanoma.
The study was designed to evaluate the overall survival in unresectable stage III or stage IV melanoma patients who had 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 under review by the US Food and Drug Administration (FDA) 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 3mg/kg + gp100 vaccine against gp100 vaccine alone, as well as ipilimumab alone versus gp100 vaccine alone.
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