07:57 AM EST, 12/15/2025 (MT Newswires) -- Immunome ( IMNM ) said Monday that its global pivotal phase 3 trial evaluating varegacestat, an investigational gamma secretase inhibitor, in patients with progressing desmoid tumors met its primary endpoint of improving progression-free survival.

The oral, once-daily treatment demonstrated a "statistically significant and clinically meaningful" 84% reduction in the risk of disease progression or death compared with placebo, the company said. The confirmed objective response rate based on RECIST v1.1 was 56% in the varegacestat arm compared with 9% with placebo, Immunome ( IMNM ) added. In an exploratory analysis, the median best change in tumor volume showed an 83% reduction with varegacestat, compared with an 11% increase in the placebo arm.

The study also met all key secondary endpoints, with "statistically significant improvements" versus placebo in landmark tumor volume reduction and worst pain intensity, Immunome ( IMNM ) added.

The company said varegacestat was generally well tolerated, with the most common adverse events being diarrhea, followed by fatigue, rash, nausea, and cough.

Based on the results, Immunome ( IMNM ) plans to submit a new drug application to the US Food and Drug Administration in Q2.

Immunome ( IMNM ) shares were up more than 31% in recent pre-bell activity Monday.

Price: 25.80, Change: +6.23, Percent Change: +31.83