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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

4.0 weeks (range 9-112 weeks) in the placebo arm(1).

In the study, the definition of angiomyolipoma response included a reduction of at least 50% relative to baseline in the sum of the volumes of all target lesions, and the absence of new lesions greater than or equal to one centimeter in diameter, with a confirmed response by radiographic scan approximately 12 weeks later(1).

Everolimus demonstrated superiority to placebo for both secondary endpoints assessed: skin lesion response rate and time to angiomyolipoma progression per central review. Skin lesion response rate, defined as the proportion of patients with a best overall skin lesion response of either complete clinical response or partial response, was 26% in patients (20 of 77) on everolimus and 0% (0 of 37) on placebo (p=0.0002). Median time to angiomyolipoma progression (time from date of randomization to date of first documented angiomyolipoma progression) was 11.37 months in the placebo arm and was not reached in the everolimus arm. Progressions were observed in 4% of patients (3 of 79) on everolimus and 21% (8 of 39) on placebo. The estimated progression-free rates at six months were 98% on everolimus and 83% on placebo (p<0.0001)(1).

The most common adverse events (AEs) in the everolimus arm (with an incidence of at least 20%) included stomatitis, nasopharyngitis, acne, headache, cough and hypercholesterolaemia. Renal events were less frequent in the everolimus arm compared to the placebo arm. The most common Grade 3 AEs in the everolimus arm (with an incidence of at least 2%) were amenorrhea, aphthous stomatitis, decreased blood phosphorus and mouth ulceration. Single Grade 4 cases of convulsion, increased blood uric acid, hypertensive crisis and neutropenia were reported in the everolimus arm(1).

Adverse events observed in this study were consistent with the known safety profile of everolimus in the TSC setting. Adverse events leading to trial discontinuation were rep
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