newsfilter
← Latest News
Business Wire·

Immunome Announces U.S. FDA Acceptance of New Drug Application for Varegacestat for the Treatment of Adults with Desmoid Tumors

IMNM
  • Immunome announced the FDA accepted its New Drug Application for varegacestat, an oral gamma secretase inhibitor, for treating adults with desmoid tumors.
  • The FDA assigned a PDUFA target action date of April 28, 2027.
  • The NDA is based on the Phase 3 RINGSIDE trial, which met its primary endpoint by showing an 84% reduction in the risk of disease progression or death compared to placebo.
  • Secondary endpoints were also met, including a 56% objective response rate versus 9% for placebo & significant improvement in worst pain intensity.
  • Exploratory analysis showed a median tumor volume reduction of -83% with varegacestat compared to +11% with placebo.
  • The drug demonstrated a manageable safety profile with common adverse events including diarrhea, fatigue, rash, nausea, & cough, mostly grade 1 or 2.
  • RINGSIDE was a global, randomized, double-blind trial involving 156 patients with progressing desmoid tumors.
  • Desmoid tumors are aggressive non-metastatic soft tissue tumors affecting approximately 1,000-1,650 people annually in the US.
  • Immunome plans to submit a Marketing Authorization Application to the European Medicines Agency by the end of 2026.
  • Immunome's pipeline also includes clinical-stage ADCs such as IM-1021 & IM-1617, alongside the investigational radiotherapy IM-3050.