newsfilter
← Latest News
Business Wire·

Immunome Announces Positive Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors

IMNM
  • The Phase 3 RINGSIDE trial met its primary endpoint, showing varegacestat significantly improved progression-free survival vs. placebo with a hazard ratio of 0.16 (p<0.0001).
  • The trial met all key secondary endpoints, achieving an objective response rate of 56% for varegacestat compared to 9% for placebo.
  • Varegacestat demonstrated a median tumor volume reduction of -83% vs. +11% for placebo in exploratory analysis.
  • The drug showed a manageable safety profile, with the most common adverse events being diarrhea (82%), fatigue (44%), rash (43%), nausea (35%), & cough (34%).
  • Immunome plans to submit a New Drug Application to the U.S. FDA in Q2 2026.
  • A conference call to discuss the topline results is scheduled for December 15, 2025, at 8:30 a.m. ET.
  • The RINGSIDE trial was a global, randomized, double-blind study involving 156 patients with progressing desmoid tumors.