Novartis drug Afinitor significantly improves progression-free survival in advanced nonfunctional gastrointestinal and lung NET
In pivotal study, everolimus reduced risk of disease progression by 52%; showed 11.0-month median progression-free survival vs 3.9 months for placebo Advanced, progressive, nonfunctional neuroendocrine tumors of GI or lung origin are rare forms of cancer with poor prognoses and limited treatment options ,[3, RADIANT-4 results highlighted at key European cancer congress; worldwide regulatory filings are underway Basel, September 27, 2015 - Novartis announced today results of a Phase III pivotal study showing Afinitor (everolimus) tablets reduced the risk of progression by 52% (hazard ratio [HR] = 0.48; 95% confidence interval [CI], 0.35-0.67; p<0.00001) vs placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin. The study, RADIANT-4, will be presented at the European Cancer Congress (ECC) 2015 in Vienna, Austria, and was highlighted in the ECC press conference on Saturday, September 26 . Additionally, the data show everolimus, a mammalian target of rapamycin (mTOR) inhibitor, extended median progression free survival (PFS) by 7.1 months: median PFS by central review was 11.0 months (95% CI, 9.23-13.3) in the everolimus arm and 3.9 months (95% CI, 3.58-7.43) in the placebo arm. Overall survival (OS) was a key secondary endpoint of the trial. While the OS data are not mature, the first interim analysis showed a trend favoring the everolimus arm.
