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Top-Line Data Available from Three Ipilimumab Pivotal Trials in Patients with Advanced Metastatic Melanoma
Date:12/10/2007

the companies aim to submit a regulatory filing to the U.S. Food and Drug Administration (FDA) in the first half of 2008.

Overall, the safety results from the three studies were generally consistent with data from previously reported clinical trials of ipilimumab and, as expected, the most common immune related adverse events (greater than five percent) consisted of rash, diarrhea, and hepatitis. Safety data from the 10 mg/kg cohorts were consistent with results from similar or lower doses of previously reported clinical data.

About the Ipilimumab Registrational Monotherapy Program

The registrational, monotherapy program evaluated ipilimumab in 487 patients with advanced Stage III or Stage IV metastatic melanoma from three clinical trials conducted at multiple centers across North America, Europe, South America and Africa. The trials included an open-label, single arm trial (008) evaluating overall response rate in 155 patients who progressed on or following standard treatment; a randomized, double-blind trial (022) evaluating the efficacy of three dose levels of ipilimumab in 216 patients who were previously treated, relapsed or failed to respond to experimental treatment or were unable to tolerate currently approved therapies; and a randomized, double-blind, placebo-controlled trial (007) in 116 patients comparing the safety of ipilimumab, with or without prophylactic oral budesonide (primarily evaluating the rate of grade 2+ diarrhea). All patients enrolled in these trials were diagnosed with advanced Stage III or Stage IV malignant melanoma.

All three studies were designed to capture clinical activity and kinetics of response at specific time points, beginning with an initial assessment at 12 weeks. Objective response determinations were verified by an independent radiology committee. Active follow-up of patients is ongoing, and many patients enrolled in the three studies are continuing to be treated with maintenance therapy.


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SOURCE Bristol-Myers Squibb Company; Medarex, Inc.
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