Debio 1143: Front-line breakthrough for Head and Neck cancer patients

Executive summary

  • First-in-class IAP antagonist
  • Compelling Phase 2 data generated in a robust trial design:
    • LRC-rate improved by 21% over SOC at 18 months after CRT
    • Highly significant and clinically compelling PFS improvement after 2 years follow-up
    • Predictable and manageable safety profile, no substantial added toxicity to CRT
    • Highly significant improvement of Duration of response (HR 0.22, p=0.003)
  • Positioning in “high risk” LA-SCCHN patients (OPC/HPVneg and heavy smokers)
  • Phase III-ready asset with attractive market opportunity in Head & Neck
  • H&N Market exclusivity until 2040
  • Flexible oral dosing regimen adaptable to various drug combinations
  • Broad potential beyond H&N:
    • Extensive clinical exploration of combinations with immune checkpoint inhibitors (ICI)
    • Other CRT settings

Results were first presented at ESMO 2019, Barcelona, Spain. Full presentation below