Shots:
- The US FDA has received NDA for Immunome’svaregacestat for the treatment of adults with desmoid tumors
- NDA is supported by the global P-III (RINGSIDE) trial assessing varegacestat (1.2mg, QD) vs PBO until disease progression or death in 156 pts with progressing desmoid tumors; eligible pts could then enter OLE phase, which is ongoing
- Trial met its 1EP, improving PFS by 84%, plus the ORR was 56% vs 9% per BICR; varegacestat also showed median best change in tumor volume of -83% vs +11% & met all key 2EPs incl. tumor reduction & pain improvement; data to be presented at ASCO’26
Ref: Businesswire | Image: Immunome |Press Release
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