BioCentury
ARTICLE | Clinical News

Novartis' Afinitor misses in Phase III HCC trial

August 7, 2013 11:38 PM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) said oral Afinitor everolimus plus best supportive care (BSC) missed the primary endpoint of improving overall survival (OS) vs. placebo plus BSC in the Phase III EVOLVE-1 trial to treat hepatocellular carcinoma (HCC). As a result, the pharma said it will not proceed with regulatory applications for the oral mTOR protein inhibitor in the indication. The double-blind, international trial enrolled 546 patients with locally advanced or metastatic HCC whose disease progressed after treatment with or who were intolerant to Nexavar sorafenib. Afinitor is approved in over 100 countries, including the U.S. and those of the EU, to treat advanced renal cell carcinoma (RCC). In the U.S. and EU, the drug is also approved for neuroendocrine tumors of pancreatic origin and to treat postmenopausal women with hormone receptor-positive/HER2-negative breast cancer. ...