Immunome's Varegacestat Phase 3 Data Set for High-Profile ASCO Presentation — Immunome, Inc.

Event summary

Immunome's Phase 3 RINGSIDE trial data for varegacestat in desmoid tumors selected for oral presentation at 2026 ASCO Annual Meeting.
Trial included 156 patients, largest randomized study in progressing desmoid tumor population.
Primary endpoint: progression-free survival; secondary endpoints include ORR and pain intensity reduction.
NDA submission to FDA planned for Q2 2026 following December 2025 topline results.

The big picture

This ASCO presentation represents a critical validation milestone for Immunome's lead asset, varegacestat. The focus on desmoid tumors—a rare but debilitating condition—highlights the growing emphasis on targeted therapies for niche oncology indications. With positive Phase 3 results already reported, successful NDA submission could position Immunome as a key player in this underserved market segment.

What we're watching

Regulatory Pathway: Whether Q2 2026 NDA submission timeline can be maintained following ASCO data presentation.
Clinical Validation: How detailed RINGSIDE results compare to December 2025 topline data and competitor offerings.
Market Differentiation: The pace at which Immunome can position varegacestat as best-in-class for desmoid tumors.