Immunome reported positive top-line Phase III results for its oral gamma secretase inhibitor varegacestat, showing an 84% reduction in the risk of disease progression or death versus placebo in progressing desmoid tumors. The company said the data meet the trial’s primary endpoint and plans to file a New Drug Application (NDA) with the U.S. FDA by the second quarter of next year. Desmoid tumors are rare, locally aggressive soft-tissue neoplasms; progression-free survival (PFS) is a standard pivotal endpoint used to gauge drug benefit in these patients. Analysts and investors flagged the magnitude of benefit as unusually strong for a small-molecule agent in a rare tumor, and Immunome’s shares jumped on the news.
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