Phase 3 Study of Afinitor for Tuberous Sclerosis Complex

Novartis announced results from its Phase 3 EXIST-1 study of Afinitor (everolimus) for the treatment of patients with subependymal giant cell astrocytomas (SEGAs) associated with tuberous sclerosis complex (TSC). EXIST-1 (EXamining everolimus In a Study of TSC) is a randomized, placebo-controlled, double-blind, parallel-group, international, multicenter study examining the efficacy and safety of everolimus vs. placebo for the treatment of patients with SEGA associated with TSC. EXIST-1 trial met its primary endpoint of SEGA response rate, with 35% of patients (27/78) receiving everolimus experiencing a 50% or greater reduction in SEGA volume relative to baseline vs. 0% of patients on placebo (P<0.0001).

Afinitor is currently approved in the U.S. to treat patients with SEGA associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical intervention.

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