ESMO 2014: Novartis’ Afinitor; and Janssen’s Zytiga

Swiss pharma major Novartis (NOVN: VX) on Saturday presented final results on overall survival (OS) from a Phase III trial of Afinitor (everolimus), showing that this is the first treatment for advanced pancreatic neuroendocrine tumors (NET) to provide overall survival of more than 3.5 years in Phase III trial .

Overall survival was a secondary endpoint of the trial. The findings were presented at the European Society for Medical Oncology (ESMO) Congress, in Madrid, Spain, and are to be submitted to health authorities for inclusion in the Afinitor prescribing information.

Results from the RADIANT-3 trial showed a median OS of 44.02 months (95% confidence interval [ci]:35.61)(95% confidence interval [ci]:51.75) in the everolimus treatment arm and 37.68 months (95% ci:29.14)(95% ci:45.77) in the placebo arm. The 6.34 month difference between the two arms was not statistically significant (Hazard Ratio [HR] 0.94; 95% CI: 0.73, 1.20; p=0.300) [1]. A high crossover of patients from placebo to everolimus (85%) likely contributed to the long median OS in the placebo arm of 37.68 months and may have confounded the ability to detect a difference in the OS results.