Immunome, Inc. announced positive topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat in patients with progressing desmoid tumors.
Varegacestat significantly improved progression-free survival vs. placebo with a hazard ratio of 0.16, p<0.0001.
The trial also met all key secondary endpoints, with varegacestat delivering an objective response rate of 56% and being generally well tolerated with a manageable safety profile.
Primary Endpoint Met
Varegacestat significantly improved progression-free survival vs. placebo with an 84% reduction in the risk of disease progression or death.
Secondary Endpoints Achieved
Varegacestat demonstrated an objective response rate of 56% and met all key secondary endpoints vs. placebo.
New Drug Application Planned
Immunome plans to submit a New Drug Application to the U.S. FDA in Q2 2026.
- The RINGSIDE trial results indicate varegacestat's potential as a first-in-class cancer therapy, offering significant improvements in patient outcomes.
- Varegacestat's successful performance in the trial positions it as a promising treatment option for patients with desmoid tumors.
The positive topline results from the Phase 3 RINGSIDE trial highlight the efficacy and safety of varegacestat in treating patients with desmoid tumors, marking a significant advancement in oncology treatment.