Conference Presentation

Immunome to detail RINGSIDE's 84% progression-risk cut for varegacestat at ASCO

The Phase 3 desmoid tumor trial already met its primary endpoint; Immunome filed an NDA in April and will present full data as it awaits FDA review.

By AppliedXLJuly 13, 2026Trial NCT04871282

Executive Summary

Immunome will present the full dataset behind a Phase 3 desmoid tumor trial that already cleared its primary endpoint, giving oncologists and regulators a fuller view of a result the company has only summarized in topline form so far.
The trial tests a gamma-secretase inhibitor in a rare, chronically progressive soft-tissue tumor where surgery and watchful waiting remain common, and where one drug in the same mechanism class has already reached approval.
The sponsor has already filed for U.S. approval based on the topline result, so the ASCO presentation lands as supporting evidence during an active review rather than as a stand-alone catalyst.
The result raises the question of whether varegacestat's magnitude of effect distinguishes it from the approved comparator in the same drug class, or simply replicates a benefit the field has already established.

The disclosure

Immunome, Inc. said data from RINGSIDE, its global, randomized, placebo-controlled Phase 3 trial of varegacestat in patients with progressing desmoid tumors, have been selected for an oral abstract presentation at the 2026 ASCO Annual Meeting. The trial is registered as NCT04871282 and enrolled 198 patients across sites in the United States, the United Kingdom, Spain, Germany, and eight other countries. The company disclosed topline results in December 2025: the trial met its primary endpoint of progression-free survival versus placebo, with a statistically significant 84% reduction in the risk of disease progression or death (hazard ratio 0.16, p<0.0001). Immunome+1

The secondary data

RINGSIDE also met all key secondary endpoints, including an objective response rate of 56% versus 9% with placebo (p<0.0001), assessed by blinded independent central review. In an exploratory analysis, varegacestat produced a median best change in tumor volume of -83%, against +11% for placebo, also by blinded central review. Immunome said the drug was generally well tolerated with a safety profile consistent with the gamma-secretase inhibitor class. The ASCO oral session will give oncologists their first look at the granular data, including duration and consistency of response, behind those topline figures. Immunome

Regulatory posture

Immunome submitted a New Drug Application to the FDA for varegacestat in adults with desmoid tumors in April 2026, and plans a Marketing Authorization Application to the European Medicines Agency by the end of 2026. AL102, the trial name for varegacestat, previously received FDA Fast Track designation in 2022 and Orphan Drug designation in November 2023. The ASCO presentation therefore arrives after the regulatory filing rather than ahead of it, positioning the conference data as supporting evidence for an application already under review rather than a catalyst that itself triggers a filing decision. Immunome

Competitive frame

Desmoid tumor drug development is concentrated around a small number of mechanisms: nirogacestat, a gamma-secretase inhibitor from the same target class, is already approved and in Phase 4 study (NCT07176689), while other agents in the indication target the WNT pathway, TGFBR1, and TBL1 in earlier-phase programs. Varegacestat's 84% risk reduction and hazard ratio of 0.16 give the field a same-class data point to weigh against nirogacestat's established profile. Because the mechanism is already validated by an approved comparator, the informative question for this readout is whether varegacestat's effect size and tolerability hold up as a second entrant in the same class, rather than whether the mechanism itself works.

Trial timeline

RINGSIDE's primary completion date moved three times in the registry, from January 2025 to October 2025 and finally to December 3, 2025, while enrollment grew from 192 to 198 patients in June 2025. The trial has been listed as Active, not recruiting since February 2024, consistent with a study that finished enrolling and is following patients rather than one experiencing operational disruption. Those shifts predate and do not bear on the ASCO data, which reflect the trial's already-completed primary analysis. NCT04871282

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.