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In advanced, progressive pNET

AFINITOR more than doubled median PFS vs placebo1,2

Kaplan-Meier curve for progression-free survival in the RADIANT-3 study of AFINITOR
AFINITOR arm, 95% CI: 8.4-13.9. Placebo arm, 95% CI: 3.1-5.4. HR=0.35. 95% CI: 0.27-0.45. P<0.001 by stratified one-sided log-rank test.
  • AFINITOR extended median PFS in patients with advanced, progressive pNET by more than 6 months (P<0.001)1,2
  • Treatment with AFINITOR resulted in a 65% reduction in risk of progression or death (HR=0.35; 95% CI: 0.27-0.45; P<0.001)1,2
CI, confidence interval; HR, hazard ratio; PFS, progression-free survival; pNET; pancreatic neuroendocrine tumor(s).

Final OS results from RADIANT-3

Patient population of the RADIANT-4 study by primary site of tumor originKaplan-Meier curve for overall survival in the RADIANT-3 study of AFINITOR

AFINITOR arm, 95% CI: 35.61-51.75. Placebo arm, 95% CI: 29.14-45.77. HR= 0.94. 95% CI: 0.73-1.20. Log-rank P=0.300.
  • 44.0-month median OS in patients treated with AFINITOR compared to 37.7 months for the placebo/crossover arm; not statistically significant but clinically meaningful3
    • (AFINITOR arm, 95% CI: 35.61-51.75. Placebo arm, 95% CI: 29.14-45.77. HR=0.94. 95% CI: 0.73-1.20. Log-rank P=0.300)3
    • Crossover to AFINITOR by 85% of the patients initially randomized to the placebo arm may have confounded the comparative analysis3
  • Despite an 85% crossover, AFINITOR demonstrated a clinically meaningful 6.3-month median improvement of OS3
CI, confidence interval; HR, hazard ratio; OS, overall survival; pNET; pancreatic neuroendocrine tumor(s); RADIANT, RAD001 in Advanced Neuroendocrine Tumors.
  1. AFINITOR [summary of product characteristics]. Basel, Switzerland: Novartis Pharma AG; May 2016.
  2. Yao JC, Shah MH, Ito T, et al; for the RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011;364(6):514-523.
  3. Yao JC, Pavel M, Lombard-Bohas C, et al. Everolimus for the treatment of advanced pancreatic neuroendocrine tumors: final overall survival results of a randomized, double-blind, placebo-controlled, multicenter phase III trial (RADIANT-3). Paper presented at: 2014 Congress of the European Society for Medical Oncology (ESMO); September 26-30, 2014; Madrid, Spain.