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Monday, June 3, 2024

Ideaya Phase 2 IST in Neoadjuvant Uveal Melanoma at ASCO and Clinical Update

 

  • 75% eye preservation rate (9 of 12 enucleation patients)
  • ~67% (8 of 12 enucleation patients) observed greater than 30% tumor shrinkage and median tumor shrinkage of 47% by volume change after 6 months
  • Company-sponsored Phase 2 Neoadjuvant UM: Over 40 patients enrolled, and for the 8 patients with ≥4-months of darovasertib observed median tumor shrinkage of 72% by volume change and eye preserved for the majority of enucleation patients
  • Targeting Type C meeting with the FDA in H2 2024 for guidance on potential registrational trial for darovasertib in neoadjuvant UM setting
  • Projected global annual incidence of primary UM is ~8,000 to ~10,000 patients

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