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RAD001 Combined with Sandostatin LAR(R) Depot and as Monotherapy Controls Growth of Rare Pancreatic Neuroendocrine Tumors
Date:9/13/2008

01, with or without Sandostatin LAR Depot, to provide tumor shrinkage or stability and to extend time without disease progression in patients who currently have limited treatment options."

The study explores the potential of mTOR inhibition for patients with pancreatic NET by examining RAD001 alone or in combination with standard of care treatment, Sandostatin LAR Depot. RAD001 is a once-daily oral therapy that continuously inhibits the mTOR protein, a central regulator of cell division and tumor blood vessel growth.

"These findings begin to establish the role of RAD001 as a promising new option for patients with a rare and deadly form of cancer that historically has not responded well to any treatment," said David Epstein, President and CEO of Novartis Oncology. "The combination of RAD001 and Sandostatin LAR Depot may offer a novel treatment approach for disease and symptom control in patients with pancreatic neuroendocrine tumors who are resistant to chemotherapy."

Two Phase III trials investigating the use of RAD001 and Sandostatin LAR Depot are underway in patients with pancreatic NET and carcinoid tumors. The endpoints will be progression-free survival and overall survival.

RADIANT-1 results

RADIANT-1 is a Phase II international, multi-center, open label, stratified study of RAD001 in 160 patients with advanced pancreatic NET, who became resistant to prior treatment with cytotoxic chemotherapy. In the monotherapy treatment group, 115 patients received RAD001 alone. In the combination treatment group, 45 patients whose tumors progressed during treatment with Sandostatin LAR Depot continued treatment with the addition of RAD001.

The primary endpoint of RADIANT-1 was objective response rate (complete response and partial response) in the monotherapy group. The secondary endpoints included response rate in the combination treatment group, as well as response duration, safety and tolerability, progression-free survival (PFS)
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SOURCE Novartis Pharmaceuticals Corporation
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