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In advanced, progressive pNET

RADIANT-3 has a robust clinical trial design

RADIANT-3: The largest (N=410) phase 3 trial in the treatment of advanced, progressive pNET1

RADIANT-3 trial design

*0 vs 1 and 2.
Yes or no.
BSC could include SSA therapy.
§Crossover to AFINITOR was allowed upon disease progression.

Trial overview1

  • This was a prospective, double-blind, randomized, parallel-group, placebo-controlled, international, multicenter Phase III study of treatment with AFINITOR versus placebo in advanced, progressive pNET
    • The primary end point was PFS
  • After the primary end point was achieved, the study was unblinded and patients were enrolled in the open-label period to assess the secondary end point of OS1
    • Other secondary end points: safety, objective response rate (complete response or partial response), and response duration

Key eligibility criteria1

  • Advanced (unresectable or metastatic) pNET
  • Radiologic disease progression ≤12 months prior to randomization
  • Measurable disease per RECIST
  • Prior antitumor therapy allowed
  • WHO performance status ≤2
PFS was defined as the time from randomization to the first documentation of disease progression or death from any cause.
BSC, best supportive care; OS, overall survival; PFS, progression-free survival; pNET, pancreatic neuroendocrine tumor(s); RADIANT, RAD001 in Advanced Neuroendocrine Tumors; RECIST, Response Evaluation Criteria In Solid Tumors; SSA, somatostatin analogue; WHO, World Health Organization.
  1. 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.