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Novartis announced today that results of a Phase III study show Afinitor (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival, or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET).
The study, RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors), was presented at the 12th World Congress on Gastrointestinal Cancer and is part of the largest clinical trial program in patients with advanced NET.
Afinitor 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.
Findings from the RADIANT-3 study demonstrated that everolimus extended the median time without tumor growth from 4.6 to 11.0 months when compared with placebo. Additionally, the data showed everolimus reduced the risk of cancer progression by 65% (hazard ratio=0.35 [95% confidence interval, 0.27 to 0.45]; p<0.0001).
“It’s encouraging to see that by targeting the mTOR pathway, treatment with everolimus can provide a significant progression-free survival advantage over placebo in patients with advanced pancreatic NET,” said James Yao, MD, Associate Professor of Medicine, The University of Texas MD Anderson Cancer Center. “These results further validate earlier trials and demonstrate the potential benefit everolimus can provide to these patients.”
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 overall survival for patients with advanced pancreatic NET is 24 months. Currently, surgery and chemotherapy are the only available treatment options for patients with advanced pancreatic NET.
“Our commitment to patients with advanced NET continues with the RADIANT trial program, which is the largest in patients with advanced NET,” said Hervé Hoppenot, President, Novartis Oncology.
“With this study, Novartis continues to make progress towards our goal of providing patients with treatment options for this rare and hard to treat cancer.”
