Afinitor (everolimus) extended progression-free survival in Phase III trial in advanced gastrointestinal or lung neuroendocrine tumours

Novartis has announced that the Phase III study of Afinitor® (everolimus) tablets plus best supportive care in patients with advanced nonfunctional neuroendocrine tumours (NET) of gastrointestinal (GI) or lung origin met its primary endpoint: significant extension of progression-free survival (PFS) compared to placebo plus best supportive care.

The RADIANT-4 study is part of one of the largest clinical trial programs in NET.

NET are a rare type of cancer that originate in neuroendocrine cells found throughout the body, and are most often found 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;
• nonfunctional NET do not secrete hormones, and may only produce symptoms caused by the tumour’s growth, such as intestinal blockage, pain and bleeding.

At time of diagnosis, up to 44% of patients with GI NET and 28% of patients with lung NET have advanced disease, meaning the cancer has spread to other parts of the body and is more difficult to treat. There are limited treatment options for patients with advanced GI or lung NET.

Worldwide regulatory filings for everolimus are planned for 2015

“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.”

Full results from the RADIANT-4 study will be submitted to a major medical meeting. Worldwide regulatory filings are planned for 2015.