Results of Afinitor in RADIANT - 3 trial for Pancreatic Neuroendocrine Tumor - Novartis

Novartis presented final results on overall survival (OS) from RADIANT-3 trial of Afinitor (everolimus) tablets plus best supportive care (BSC) compared to placebo plus BSC in patients with well-differentiated advanced and progressive Pancreatic Neuroendocrine Tumors (pNET). Overall survival was a secondary endpoint of the trial. The findings were presented at the European Society for Medical Oncology (ESMO) Congress, September 26-30, 2014 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, 51.75) in the everolimus treatment arm and 37.68 months (95% CI: 29.14, 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). 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.