Novartis says late-stage clinical data show that its cancer drug Afinitor extended progression-free survival in patients with advanced nonfunctional neuroendocrine tumours (NET) of gastrointestinal or lung origin.
A Phase III trial of the drug - called RADIANT-4 - met its primary endpoint by demonstrating significant extension of progression-free survival (PFS) compared to placebo plus best supportive care.
NET are a rare type of cancer that originate in neuroendocrine cells found throughout the body, most often found in the GI tract, lungs or pancreas. Among other cancer indications, Afinitor (everolimus) is already approved in more than 95 countries for pancreatic NET.
There are limited treatment options for patients suffering from GI or lung NET, an unmet need Novartis is hoping to address through expanding the scope of Afinitor.
As such, full results from study, which are to be submitted for presentation at a major medical meeting, will form the basis of worldwide regulatory filings in these additional indications this year.
The treatment is in the same class as Roche's RA blockbuster Actemra/RoActemra (tocilizumab) and earlier this year,