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Pivotal Phase III trial of Novartis drug Afinitor met primary endpoint

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Novartis announced today that a Phase III study of Afinitor (everolimus) tablets plus best supportive care met its primary endpoint, showing the drug significantly extended progression-free survival, or time without tumor growth, in patients with advanced pancreatic neuroendocrine tumors (NET). The study, RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors), is part of the largest clinical trial program of its kind.

Everolimus is approved under the trade name Afinitor (everolimus) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.

Pancreatic NET can grow aggressively and at time of diagnosis nearly 60% of all patients have advanced disease, meaning the cancer has spread to other parts of the body and has become more difficult to treat. The median survival rate for patients with advanced pancreatic NET is 17 months. Currently, surgery and chemotherapy are the only approved treatment options for patients with advanced pancreatic NET.

“Everolimus was developed to inhibit the mTOR protein, which is a critical target in treating various cancers, including NET. Results from RADIANT-3 demonstrate that everolimus has the potential to become an important treatment option for patients with advanced pancreatic NET, where there is a major unmet need,” said Herve Hoppenot, President, Novartis Oncology. “These study results will serve as the basis of worldwide regulatory filings for everolimus and bring us one step closer to our goal of offering these patients a new therapy.”

Full results from the RADIANT-3 study will be submitted for presentation at the European Society for Medical Oncology annual meeting taking place in Milan, Italy in October. Additionally, worldwide regulatory filings are planned for 2010.

RADIANT-3 is a Phase III prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study. The trial examined the efficacy and safety of everolimus plus best supportive care versus placebo plus best supportive care in 410 patients with advanced pancreatic NET, also known as islet cell tumors. Patients who met the study’s entry criteria were randomized 1:1 to receive either daily everolimus (10 mg) or daily placebo orally.

The primary endpoint of RADIANT-3 is progression-free survival. Secondary endpoints include safety, objective response rate and overall survival.

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