Immunome Phase 3 RINGSIDE trial of varegacestat meets primary endpoint with 84% risk reduction

Immunome Inc.

Progression-free survival HR=0.16 (95% CI 0.071-0.375, p<0.0001) vs placebo in desmoid tumors.
Confirmed ORR 56% with varegacestat vs 9% with placebo (p<0.0001); median tumor volume change -83% vs +11%.
All key secondary endpoints met; safety consistent with GSI class (most common AEs: diarrhea 82%, fatigue 44%, rash 43%).
NDA submission to FDA planned for Q2 2026; additional data to be presented at upcoming medical conference.

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