Novartis' Afinitor meets primary endpoint in Ph III study of patients with advanced NET; Tasigna shows benefits over Glivec/Gleevec

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 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. Afinitor generated first-quarter 2010 sales of $41 million for the company, and is forecast to bring in blockbuster (ie, over $1 billion) revenues in due course. A label expansion for Afinitor beyond RCC will enable the drug to generate higher sales in the future, boosting Novartis' already substantial oncology drug franchise of $9 billion last year.

In the USA, Afinitor is approved for those RCC patients who have failed treatment with global drugs behemoth Pfizer's Sutent (sunitinib) or German major Bayer's Nexavar (sorafenib).

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 drugmaker noted. 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.