Immunome Announces Oral Presentation of Phase 3 RINGSIDE Data at 2026 ASCO Annual Meeting

Immunome, Inc. ("Immunome") (NASDAQ:IMNM), a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies, today announced that data from RINGSIDE, its global, Phase 3, randomized, placebo-controlled trial of varegacestat in patients with progressing desmoid tumors, has been selected for presentation in an oral abstract session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29–June 2, 2026, in Chicago.

"The selection of the Phase 3 RINGSIDE trial for oral presentation at ASCO reflects the importance of advancing new treatment options for patients with desmoid tumors," said Clay B. Siegall, Ph.D., President and Chief Executive Officer. "We look forward to sharing detailed results that build on the positive topline data reported in December 2025."

Oral Presentation Details

About the RINGSIDE Trial

The global, randomized, double-blind, placebo-controlled Phase 3 RINGSIDE trial (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 Varegacestat

Varegacestat (formerly AL102) 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 plans to submit a New Drug Application for varegacestat to the U.S. Food and Drug Administration in Q2 2026.

About Immunome

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, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage gamma secretase inhibitor; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. 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 "advancing," "look forward," "plans" and similar expressions to identify these forward-looking statements. These forward-looking statements include statements regarding: the potential of varegacestat; Immunome's presentation of data related to varegacestat; and Immunome's expected timing for submitting an NDA for varegacestat with the U.S. Food and Drug Administration; and other statements regarding management's intentions, plans, beliefs, expectations or 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 risks and uncertainties included under the caption "Risk Factors" in Immunome's Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 3, 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/20260421372136/en/

Immunome Contact: 

 

Max Rosett 

Chief Financial Officer 

investors@immunome.com