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news.The New England Journal of Medicine (NEJM) has published a study which found patients taking Novartis' Afinitor (everolimus) tablets experienced a decrease in the size of their subependymal giant cell astrocytoma (SEGA), a benign brain tumor associated with tuberous sclerosis (TS).
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Data from Phase I/II study showed that treatment with Everolimus was associated with a significant reduction in primary SEGA volume at six months relative to baseline on independent central review.
Reportedly, 75% of patients (21 of 28) experienced a reduction of 30% or greater in the size of their largest SEGA and 32% (9 of 28) experienced a reduction of 50% or greater at six months relative to baseline.
The study findings also showed that Everolimus therapy was associated with a clinically relevant reduction from baseline to six months in overall frequency of seizures per 24 hour video electroencephalograms (EEG).
Everolimus was recently approved in the US under the FDA’s accelerated approval program as Afinitor for patients with SEGA associated with TS who require therapeutic intervention but are not candidates for curative surgical resection.
A Phase III study is underway that compares everolimus to placebo to explore the clinical benefits of Afinitor for the treatment of patients with SEGA associated with TS.
Principal investigator of the study and Cincinnati Children’s Hospital Medical Center Tuberous Sclerosis Clinic director David Franz said that it was the first clinical trial to show that a drug has the potential to provide patients with growing SEGAs, many of whom are children, another treatment option besides brain surgery.
"In addition to decreasing the size of the brain tumors, Everolimus was associated with a reduction in the frequency of seizures," Franz said.