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Phase III Trial of Novartis Drug Afinitor® Met Primary Endpoint of Reducing SEGA Tumor Size in Patients With Tuberous Sclerosis
Date:7/7/2011

everal countries(1,5). The extension phase of the Phase II study, which is also being presented at the conference, provides data to support the treatment of patients with SEGA associated with TSC for a duration of up to three years(5).

Regulatory approvals for everolimus have been granted for this patient population as Afinitor in the United States, Canada, Brazil, Guatemala, the Philippines, Columbia and Korea, and as Votubia® in Switzerland. In June, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the approval of everolimus for this use in the European Union (EU).

About the EXIST-1 Phase III trialEXIST-1 is a Phase III randomized, placebo-controlled, double-blind, parallel group, international, multicenter study examining the efficacy and safety of everolimus versus placebo for the treatment of patients with SEGA associated with TSC. Trial patients (median age=9.46, range 0.8-26.6) were randomized to receive either everolimus (n=78) or placebo (n=39) at a daily starting dose of 4.5 mg/m2. By the cut-off date of March 2, 2011, the median treatment duration was 9.6 months (range 5.5-18.1 months) in the everolimus arm and 8.3 months (range 3.2-18.3 months) in the placebo arm. The trial met the primary endpoint of overall SEGA response rate versus placebo(1).

Three key secondary endpoints were also assessed: change in seizure frequency, time to SEGA progression and skin lesion response rate. The analysis of the first secondary endpoint, the change in seizure frequency, was inconclusive. This may have been due to the method of assessment (single 24-hour video electroencephalograms, or EEGs) and a very limited number of patients with evaluable seizures at study entry. In this trial, the impact on seizure frequency was not demonstrated. Another study specifically designed to examine the efficacy of everolimus on seizure response in patients with TSC as the primary endpoint is ongoing(1).

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SOURCE Novartis Pharmaceuticals Corporation
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