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Phase III Trial of Novartis Drug Afinitor® Met Primary Endpoint of Reducing SEGA Tumor Size in Patients With Tuberous Sclerosis
Date:7/7/2011

ctions and infestations, which were observed in 72% of patients on everolimus and 67% of patients on placebo(1).

EXIST-1 enrolled 117 patients in 10 countries, including the US, Poland, Russia, Germany, Belgium, Canada, Australia, Italy, the Netherlands and the UK(1,10).

About the Phase II studyIn this prospective, open-label, single-arm study, 28 patients aged three years and above (median age=11, range 3-34) with evidence of SEGA growth received a median daily dose of 5.29 mg/m2. The median treatment duration was 34.2 months (range 4.7-47.1 months). Of the 28 patients in the initial study, 27 were enrolled in the extension phase and 25 were still receiving everolimus at the extension phase cut-off date (December 31, 2010). No patients discontinued due to disease progression, adverse events or study drug use(5).

During this extension phase, reduction in SEGA volume was maintained over time and no patients required surgery or other therapy for SEGA or hydrocephalus. In the study, 78% of patients (7 of 9) who took everolimus for at least three years and 79% of patients (19 of 24) who took everolimus for at least two years experienced a reduction of 30% or greater in the size of their largest SEGA relative to baseline. Additionally, 56% of patients (5 of 9) who took everolimus for at least three years and 50% of patients (12 of 24) who took everolimus for at least two years experienced a reduction of 50% or greater in the size of their largest SEGA relative to baseline(5). These findings were consistent with those previously recorded at six months relative to baseline(2,5).

The most common AEs (all grades with an incidence of at least 20%) included: stomatitis or mouth sores (86%), upper respiratory tract infection (86%), sinusitis (47%), middle ear infection (36%), diarrhea (32%), fever (32%), cellulitis or acute infection of the deep tissues of skin or muscle (29%), convulsion (29%), gastroenteritis or inflammation of the gastrointest
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SOURCE Novartis Pharmaceuticals Corporation
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