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Everolimus (RAD001) Significantly Extends Progression-Free Survival in Advanced Kidney Cancer Patients After Failure of Other Targeted Therapy
Date:2/27/2008

have had no treatment options, as patients in the clinical trial on everolimus experienced a significantly longer period of time during which their cancer did not progress," said Daniel Vasella, Chairman and CEO of Novartis. "Everolimus is a targeted therapy which is being studied in multiple tumor types, and could provide significant benefit to patients suffering from cancer."

"This progression-free survival benefit demonstrates the possibilities of continuous mTOR inhibition as a promising target in oncology," said David Epstein, President and CEO, Novartis Oncology. "These data are the first from a broad clinical research program that includes studies in patients with high unmet needs suffering from a variety of cancers. Everolimus is the first compound in our dynamic oncology late-stage pipeline with six compounds in registration trials to show exciting clinical data this year."

Complete results of the RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily) trial will be submitted as a late-breaking abstract for presentation at the American Society of Clinical Oncology annual meeting in May. Worldwide regulatory filings for this indication beginning with US and EU will occur in the second half of 2008.

RECORD-1 is the largest Phase III trial to investigate the potential of the oral mTOR inhibitor everolimus as a treatment option for patients with metastatic RCC who have failed prior targeted therapy. The randomized, double- blind multi-center Phase III study compared everolimus to placebo.

Patients in the study were randomized according to Memorial Sloan- Kettering Cancer Center (MSKCC) risk criteria and prior anti-cancer therapy. MSKCC risk criteria are standard clinical criteria to determine the prognosis of patients with RCC.

In addition to RCC, everolimus is presently being evaluated in neuroendocrine tumors, lymphoma, other cancers, and tuberous sclerosis as a single agent or in combination with existing cance
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SOURCE Novartis Pharmaceuticals Corporation
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