Immunome Announces EMA Validation of Marketing Authorization Application for Varegacestat for the Treatment of Adults with Desmoid Tumors
The EMA has validated Immunome's Marketing Authorization Application for varegacestat, an oral once-daily gamma secretase inhibitor for adults with desmoid tumors, initiating centralized review in the EU. The application rests on the Phase 3 RINGSIDE trial, which met its primary endpoint with an 84% reduction in risk of progression or death (HR 0.16, p<0.0001) and an objective response rate of 56% vs 9% for placebo.
Key figures
- Drug Name
- varegacestat
- Phase Of Trial
- Phase 3
- Pdufa date
- April 28, 2027
- Orr placebo
- 9%
- Orr treatment
- 56%
- Trial patients
- 156
- Hazard ratio pfs
- 0.16
- Tumor volume best change
- -83% vs +11% placebo
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