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Novartis Drug Afinitor® Effective in Patients With Non-Cancerous Kidney Tumors Associated With TSC in Phase III Trial
Date:9/23/2011

EAST HANOVER, N.J., Sept. 23, 2011 /PRNewswire/ -- A Phase III study of Afinitor® (everolimus) tablets* in patients with non-cancerous kidney tumors, or angiomyolipomas, associated with tuberous sclerosis complex (TSC) met its primary endpoint of best overall angiomyolipoma response rate, which includes reduction in kidney tumor size and absence of new tumors. Findings from the trial, known as EXIST-2, were presented today at the International TSC Research Conference in Belfast, Northern Ireland(1).

Tuberous sclerosis complex is a genetic disorder that may cause non-cancerous tumors to form in vital organs, including the brain (SEGAs) and kidney (angiomyolipomas)(3). These kidney tumors occur in up to 80% of patients, usually occurring between the ages of 15 and 30 and increasing in prevalence with age(2,3). Angiomyolipomas are the greatest cause of morbidity and mortality in adult TSC patients, as larger tumors may cause severe bleeding, require surgical intervention or result in kidney failure(2,3). Tumor symptoms may include nausea, vomiting, pain and bleeding(3,6,7).

Results of the 118-patient, randomized, placebo-controlled Phase III EXIST-2 (EXamining everolimus In a Study of TSC) trial showed 42% of patients (33 of 79) experienced a response in the everolimus arm versus 0% of patients (0 of 39) on placebo (p<0.0001) based on best overall response rate(1). These results add to the recent positive Phase III data from a separate trial in patients with TSC, which demonstrated reduction in the size of non-cancerous brain tumors (SEGAs) with everolimus(5).

"For the first time, a large placebo-controlled study has focused specifically on angiomyolipomas in TSC patients, an area with clear unmet need," said Dr. John Bissler, lead study author and Clark D. West Endowed Chair of Nephrology at Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. "In addition to the tumor reduction seen with everolimus in this trial, s
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SOURCE Novartis Pharmaceuticals Corporation
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