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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

the results of the first secondary endpoint, the statistical plan did not provide for a formal analysis of subsequent secondary endpoints(1).

Clinically meaningful differences were observed in time to SEGA progression. Of those patients receiving everolimus, 0% of patients (0 of 78) experienced disease progression (defined as increase in SEGA volume, worsening of non-target SEGAs, appearance of new lesions or new hydrocephalus), while 15% of patients (6 of 39) on placebo progressed(1).

Clinically meaningful differences were also observed in skin lesion response rate. A partial clinical response in skin lesions (corresponding to a 50% or greater improvement) was observed by Physician Global Assessment in 42% of patients (30 of 72) receiving everolimus, compared with 11% of patients (4 of 38) receiving placebo.  No complete responses were observed(1).

Additionally, a subset of patients (n=44) in this trial had angiomyolipomas, non-cancerous kidney tumors associated with TSC(1,6). As an exploratory endpoint, an angiomyolipoma response (corresponding to a volume reduction of 50% or greater) was observed in 53% of patients (16 of 30) receiving everolimus compared to 0% of patients (0 of 14) on placebo(1).

No adverse event (AE) leading to study drug discontinuation was observed during the study. The most common AEs in the everolimus versus the placebo arm (with an incidence of at least 20% in the everolimus arm) included mouth ulceration (32% vs. 5%), stomatitis (31% vs. 21%), convulsion (23% vs. 26%) and fever (22% vs. 15%). The most common Grade 3 AEs in the everolimus versus placebo arm (with an incidence of at least 5%) were stomatitis (8% vs. 3%), fever (6% vs. 0%) and convulsion (5% vs. 5%). One Grade 4 event of gastroenteritis was reported in the everolimus arm. Adverse events were mostly mild in severity (Grade 1/2) and were largely consistent with the known safety profile of everolimus. The most clinically notable AEs were infe
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SOURCE Novartis Pharmaceuticals Corporation
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