BOTHELL, Wash. - Immunome Inc. (NASDAQ:IMNM) presented detailed results from its phase 3 RINGSIDE trial of varegacestat for desmoid tumors at the American Society of Clinical Oncology Annual Meeting today, according to a press release statement.
The trial enrolled 156 patients with progressing desmoid tumors who were randomized to receive varegacestat 1.2 mg daily or placebo. The study met its primary endpoint, showing an 84% reduction in the risk of disease progression or death compared to placebo, with a hazard ratio of 0.16 (95% confidence interval:0.071, 0.375; p<0.0001).
The confirmed objective response rate was 56% with varegacestat versus 9% with placebo (p<0.0001), as assessed by blinded independent central review. Median time to response among varegacestat responders was 8.2 months compared to 16.7 months for placebo responders.
Varegacestat showed a statistically significant improvement in worst pain intensity at week 12, with a treatment difference of -2.42 (p<0.0001). The company stated a clinically significant difference was observed at week 4. At week 24, patients treated with varegacestat had a mean change in tumor volume of -109.6 compared to +122.8 for placebo (p<0.0001).
The most common adverse events in the treatment arm were diarrhea (82%), fatigue (44%), rash (43%), nausea (35%) and cough (34%). Most adverse events were grade 1 or 2. Among premenopausal women receiving varegacestat, 56% experienced ovarian toxicity adverse events. Dose reductions occurred in 80% of varegacestat patients versus 9% with placebo. Treatment discontinuations due to adverse events occurred in 20% of varegacestat patients versus 7% with placebo.
Immunome submitted a New Drug Application to the U.S. Food and Drug Administration in April 2026 and plans to submit a Marketing Authorization Application to the European Medicines Agency by year-end 2026. The company currently trades at a market capitalization of $2.47 billion.
In other recent news, Immunome Inc. has made significant strides with its drug varegacestat. The company submitted a New Drug Application to the U.S. Food and Drug Administration for varegacestat, targeting desmoid tumors. This application follows a successful Phase 3 trial, which demonstrated an 84% reduction in the risk of disease progression or death compared to a placebo. Truist Securities has raised its price target for Immunome to $37, maintaining a Buy rating, based on the drug’s promising efficacy and safety profile. Barclays also initiated coverage of Immunome with an overweight rating and a price target of $36. Furthermore, data from the Phase 3 trial of varegacestat will be presented at the upcoming American Society of Clinical Oncology Annual Meeting. These developments highlight Immunome’s progress in the desmoid tumor treatment landscape.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
The fastest way to find out is with our Fair Value calculator. We use a mix of 17 proven industry valuation models for maximum accuracy. Get the bottom line for IMNM plus thousands of other stocks and find your next hidden gem with massive upside.