Novartis' Afinitor meets primary endpoint in Ph III SEGAs brain tumor study

Just days after demonstrating positive results in breast cancer, Swiss drug major Novartis (NOVN: VX) announced Phase III trial results that showed more than one-third of patients taking Afinitor (everolimus) tablets experienced a 50% or greater reduction in the size of their subependymal giant cell astrocytomas (SEGAs), non-cancerous brain tumors associated with tuberous sclerosis complex (TSC). This study, the largest prospective clinical trial to date in this patient population, was presented on at the International TSC Research Conference in Washington DC, USA.

Currently, Afinitor is approved in the USA to treat patients with SEGA associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical intervention. It is also cleared for kidney cancer, and Novartis says it will file for breast cancer approval before year end (The Pharma Letter July 6).

Tuberous sclerosis complex affects approximately 25,000 to 40,000 people in the USA and one to two million people worldwide, and is associated with a variety of resulting disorders including seizures, swelling in the brain (hydrocephalus), developmental delays and skin lesions.