Immunome Announces Phase 3 Trial Results for Varegacestat
Immunome announced detailed efficacy and safety results from Ringside, the global, randomized, double-blind, placebo-controlled Phase 3 trial of varegacestat in patients with progressing desmoid tumors. The data are being presented today in an oral abstract session at the 2026 American Society of Clinical Oncology, ASCO, Annual Meeting in Chicago. Immunome submitted an NDA for varegacestat to the FDA in April 2026. The Ringside trial met its primary endpoint and all key secondary endpoints. Varegacestat demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, PFS, vs. placebo, with an 84% reduction in the risk of disease progression or death. The PFS benefit observed with varegacestat vs. placebo was consistent across key subgroups, including tumor location, baseline tumor size, patient age and prior systemic desmoid tumor therapy. Varegacestat achieved a statistically significant improvement in change in worst pain intensity score at week 12. Varegacestat achieved a statistically significant improvement in change in tumor volume at week 24, as assessed by blinded independent central review. Varegacestat was generally well tolerated, with a manageable safety profile consistent with the gamma secretase inhibitor class.
