- Results from a Phase 3 clinical trial, RADIANT-4, evaluating Novartis' (NYSE:NVS) Afinitor (everolimus) in patients with advanced, progressive, nonfunctional neuroendocrine tumors (NET) originating in the GI tract or lung showed treatment with the mTOR inhibitor reduced the risk of cancer progression 52% (p<0.00001) versus placebo. The data were presented at the European Cancer Congress in Vienna, Austria.
- Median progression-free survival (PFS) in the Afinitor cohort was 11.0 months compared to 3.9 months for placebo. Overall survival (OS), a secondary endpoint, was not mature at data cutoff. Overall response rate, another secondary endpoint, was 64% versus 26% in favor of Afinitor.
- The most common adverse events in patients treated with Afinitor were stomatitis (9%), diarrhea (7%) and infections (7%).
- The results will support global regulatory submissions seeking approval for Afinitor for the treatment of advanced, progressive, non-functional GI and lung NET. Afinitor is currently cleared in more than 95 countries for NET of pancreatic origin in addition to four other indications.
- NET are a rare type of cancer that originates in the neuroendocrine cells throughout the body.