Novartis’ Afinitor Meets its Primary Endpoint in a Late-Stage Study in Patients with NET

Novartis’ cancer drug Afinitor extended progression-free survival (PFS) in a late-stage study of patients with advanced nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin, paving the way for an expanded indication.

The company said that the Phase III RADIANT-4 study Afinitor (everolimus) tablets plus best supportive care in patients with nonfunctional NET of GI or lung origin met its primary endpoint of a statistically significant improvement in PFS compared to placebo plus best supportive care. The late-stage trial is part of one of the largest clinical trial programs in NET.

NET are a rare type of cancer that starts in the neuroendocrine cells found throughout the body, most often in the GI tract, lungs or pancreas. NET can be functional or nonfunctional. Functional NET produce symptoms caused by the secretion of hormones and other substances, whereas nonfunctional NET do not secrete hormones and may only produce symptoms caused by the tumor’s growth. These symptoms can include intestinal blockage, pain and bleeding. Up to 44 percent of patients with GI NET and 28 percent of patients with lung NET have advanced disease at the time of diagnosis, and limited treatment options exist for patients with advanced GI or lung NET.

With positive late-stage results, Novartis plans to file for approval of the drug in 2015. The company said that full results from the study will be submitted for presentation at a major medical meeting.

“We look forward to presenting the findings from the RADIANT-4 trial of everolimus, which has the potential to become an important treatment option for patients with advanced nonfunctional GI or lung NET,” said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. “The results will serve as the basis of planned worldwide regulatory filings for everolimus in these two types of NET, bringing us closer to our goal of offering Afinitor for these patients.”

In the US, Afinitor is already approved for locally advanced, metastatic or unresectable progressive neuroendocrine tumors of pancreatic origin and for treatment of patients with advanced renal cell carcinoma (RCC) following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy.

Source: Novartis

Last updated: 5/22/15; 8:40am EST

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