The drug Afinitor® (everolimus) is currently be studied in a Phase III clinical trial for patients with nonfunctional neuroendocrine tumors (NET) of the gastrointestinal (GI) tract or lungs. The trial is ongoing, but findings so far are promising: patients treated with Afinitor plus best supportive care appear to live longer without cancer progression than patients treated with placebo plus best supportive care.
Afinitor is an oral medication that works by inhibiting a protein known as mTOR. The mTOR protein plays an important role in regulating cancer cell division and blood vessel growth. Afinitor has been approved for the treatment of kidney cancer since 2009.
Neuroendocrine tumors form from cells throughout the body that release hormones into the blood in response to a signal from the nervous system. These cells are most often found in the GI tract, lungs, and pancreas. Functional NETs secrete hormones and cause symptoms, whereas nonfunctional NETs (the type included in this study) don’t secrete hormones; symptoms of nonfunctional NETs are caused by the tumor’s growth and include intestinal blockage, pain, and bleeding. Once NETs have spread to other sights in the body, they become difficult to treat.
This current trial, RADIANT-4, of Afinitor in NETs that originate in the GI tract or lung is ongoing. The researchers have met their main objective (or primary endpoint), however: improved survival without cancer progression.
Full results from the RADIANT-4 study will be released at a later date. These findings will also include safety, objective response rate (partial or complete response), and overall survival.
“We look forward to presenting the findings from the RADIANT-4 trial of everolimus [Afinitor], 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.
Reference: Novartis drug Afinitor® extended progression-free survival in Phase III trial in advanced gastrointestinal or lung neuroendocrine tumors [press release]. Novartis website. Available at: https://www.novartis.com/news/media-releases/novartis-drug-afinitor®-extended-progression-free-survival-phase-iii-trial. Accessed July 31, 2015.