Immunome Presents Additional Clinical Data for Varegacestat in Desmoid Tumors at ESMO 2026

Exploratory week-48 results showed lower symptom burden and better physical function with varegacestat than with placebo.

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• Rapid oral presentation highlights improvements in patient-reported symptom burden and physical function through week 48
• Four presentations build on the previously reported Phase 3 RINGSIDE results

BOTHELL, Wash.--(BUSINESS WIRE)-- Immunome, Inc. (Nasdaq: IMNM), a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced the presentation of additional clinical data for varegacestat, its investigational, oral, once-daily gamma secretase inhibitor, at the 2026 European Society for Medical Oncology (ESMO) Congress. The data were featured in four presentations, including a rapid oral presentation on patient-reported outcomes from the Phase 3 RINGSIDE trial in patients with progressing desmoid tumors and three posters providing further analyses of varegacestat’s clinical profile.

“For patients with desmoid tumors, treatment goals extend beyond tumor shrinkage to include symptom relief and improved physical function,” said Bob Lechleider, M.D., Chief Medical Officer of Immunome. “These presentations build on the previously reported RINGSIDE results and offer additional insight into varegacestat’s potential to address the burden of this disease.”

The rapid oral presentation included exploratory analyses of patient-reported symptom burden and physical function that complement the pain results previously presented at ASCO 2026. At week 48, patients treated with varegacestat had a least-squares mean change from baseline in the GODDESS TSS-5 symptom score of -1.50 vs. +0.59 for patients receiving placebo, with lower scores indicating lower symptom burden. On the PROMIS Physical Function measure, where higher scores indicate better function, the least-squares mean change from baseline was +3.90 with varegacestat vs. -3.04 with placebo at week 48.

Immunome also presented three posters covering RINGSIDE primary efficacy results and T2-weighted MRI signal intensity changes, a detailed analysis of safety in RINGSIDE, and exposure-response relationships across the varegacestat clinical development program.

As previously reported and presented at the 2026 ASCO Annual Meeting, RINGSIDE met its primary endpoint and all key secondary endpoints. The confirmed objective response rate (ORR) based on RECIST v1.1 was 56% with varegacestat vs. 9% with placebo (p<0.0001), as assessed by blinded independent central review. Varegacestat improved progression-free survival (PFS) vs. placebo, with an 84% reduction in the risk of disease progression or death (hazard ratio [HR] = 0.16, 95% confidence interval [CI]: 0.071, 0.375; p<0.0001). The trial also demonstrated statistically significant improvements in change in tumor volume at week 24 and change in worst pain intensity score at week 12 (p<0.0001 for each), with a clinically meaningful pain difference evident by week 4. The most common adverse events with varegacestat were diarrhea, fatigue, rash, nausea, and cough.

ESMO 2026 Presentation Details

All four presentations took place on October 26, 2026, in Madrid.

Rapid Oral Presentation

3724RO — Patient Reported Outcomes (PROs) with Varegacestat Versus Placebo (PBO) in Progressing Desmoid Tumors: Results from RINGSIDE Part B
Presenter: Dr. Winette T. van der Graaf

Poster Presentations

3754P — Detailed Safety Analysis of Varegacestat Treatment for Desmoid Tumors in the RINGSIDE Phase 3 Trial
Presenter: Dr. Piotr Rutkowski

3755P — RINGSIDE Phase 3 Study of Varegacestat in Desmoid Tumors: Primary Results and T2-weighted Signal Intensity Changes
Presenter: Dr. Bernd Kasper

3777P — Exposure-Response (ER) Analyses to Support the Recommended Dose of Varegacestat (VAR) for Patients (Pts) With Desmoid Tumors (DT)
Presenter: Gerald Fetterly

About the RINGSIDE Trial

The global, randomized, double-blind, placebo-controlled Phase 3 RINGSIDE trial (ClinicalTrials.gov Identifier: NCT04871282) evaluated the efficacy and safety of varegacestat in patients with progressing desmoid tumors. A total of 156 patients were randomized to receive varegacestat 1.2 mg daily or placebo until disease progression or death, representing the largest randomized study in this population. The primary endpoint of the trial was progression-free survival as assessed by blinded independent central review. Statistically controlled secondary endpoints were confirmed ORR using RECIST v1.1 and change in tumor volume at week 24, both determined by blinded independent central review, as well as change in pain intensity at week 12 as determined using a patient-reported outcome instrument. Additional secondary endpoints included duration of response, best reduction in tumor volume, patient-reported outcomes, and safety and tolerability. RINGSIDE includes an open-label extension phase, which is ongoing.

About Desmoid Tumors

Desmoid tumors (also known as aggressive fibromatosis or desmoid-type fibromatosis) are aggressive non-metastatic soft tissue tumors that are prone to recurrence. Approximately 1,000-1,650 people are diagnosed with desmoid tumors each year in the United States, and there are approximately 10,000-11,000 actively managed patients. Those affected face debilitating pain, deformity, and, in some cases, life-threatening organ damage. The chronic pain and physical limitations associated with desmoid tumors lead to a high clinical burden and impaired quality of life. Although desmoid tumors are not considered cancerous, they often require systemic treatment to prevent permanent disability and alleviate disease burden.

About Varegacestat

Varegacestat is an investigational, oral, once-daily gamma secretase inhibitor. In December 2025, Immunome reported positive topline results for the Phase 3 RINGSIDE trial of varegacestat in adults with progressing desmoid tumors. Immunome’s NDA for varegacestat was accepted by the FDA in July 2026 (PDUFA target action date of April 28, 2027) and the company plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026.

About Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates (ADCs). Our pipeline includes varegacestat, an investigational, oral, once-daily gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; IM-3050, a clinical-stage FAP-targeted radiotherapy; and IM-1340, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. For more information, visit www.immunome.com.

Cautionary Statement Regarding Forward Looking Statements

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We use words such as “potential,” “plans,” “committed to” and similar expressions to identify these forward-looking statements. These forward-looking statements include statements regarding: the potential therapeutic benefits of varegacestat; the regulatory review and potential approval of varegacestat; Immunome’s plans to submit a marketing authorization application for varegacestat; and the potential of Immunome’s targeted oncology therapies to be first-in-class or best-in-class therapies; and other statements regarding management’s intentions, plans, beliefs, expectations and forecasts for the future.

These forward-looking statements are based on Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including the risk that varegacestat may not receive regulatory approval or achieve its anticipated therapeutic benefits; the risk that regulatory review or submissions for varegacestat may be delayed or unsuccessful; the risk that preclinical results may not be predictive of clinical performance or that initial clinical results may not be indicative of subsequent results; the risk that regulatory approvals for Immunome’s product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that the timing, conduct, enrollment or results of clinical trials may differ from current expectations; the risk that Immunome will not be able to realize the benefits of its strategic transactions; Immunome’s ability to advance and expand its ADC pipeline; and other risks and uncertainties included under the caption “Risk Factors” in Immunome’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the Securities and Exchange Commission on August 11, 2026. These documents can also be accessed on Immunome’s website at www.immunome.com by clicking on the link “Financials” under the “Investors” tab. The forward-looking statements included in this press release are made only as of the date hereof. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261026171397/en/

Investor Contact
Max Rosett
Chief Financial Officer
investors@immunome.com

Source: Immunome, Inc.

Key Terms

gamma secretase inhibitor medical

A gamma secretase inhibitor is a type of drug that blocks an enzyme (gamma secretase) which acts like a pair of molecular scissors cutting larger proteins into smaller, sometimes harmful, fragments. Investors watch these drugs because they aim to reduce production of sticky protein fragments implicated in diseases such as Alzheimer’s and certain cancers; their success or failure in clinical trials, safety profile, and regulatory decisions can strongly affect a biotech company's value.

least-squares mean technical

An adjusted average calculated from a statistical model that estimates what a group’s typical outcome would be after accounting for other influencing factors (like age, baseline status, or different study conditions). Investors use it to compare results more fairly—for example, to judge a drug’s effect or a strategy’s performance while removing imbalances—so it helps assess true effect sizes that can affect clinical, regulatory, and valuation decisions.

progression-free survival medical

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

hazard ratio medical

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

recist v1.1 medical

RECIST v1.1 is a standardized set of rules used in cancer trials to measure how solid tumors change over time, defining when tumors shrink, grow, or stay the same based on imaging scans. Investors care because these consistent measurements determine key trial results and regulatory decisions—like whether a drug is seen as effective—so RECIST-based outcomes directly affect a therapy’s approval prospects, market potential, and company valuation.

pdufa regulatory

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.