Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.
randomizedmedical
Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.
placebo-controlledmedical
"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.
desmoid tumorsmedical
Desmoid tumors are rare growths that arise from connective tissue and, while not spreading to other organs like cancers, can grow aggressively and invade nearby muscles, nerves or organs—think of roots that don’t seed new plants but can tangle and damage a garden. They matter to investors because their unpredictable course and limited treatment options create clear needs for new therapies, influencing clinical trial activity, regulatory attention, and the commercial potential of drugs targeting this condition.
American Society of Clinical Oncology (ASCO)medical
A major professional organization for cancer doctors and researchers that organizes influential conferences, publishes clinical guidance and peer-reviewed research, and sets standards for cancer care. For investors, ASCO’s meetings and publications often reveal early clinical trial results, treatment trends and guideline changes that can affect the commercial prospects of drugs, diagnostic tools and medical services—think of it as both a trade show and a rule book for the oncology field.
oral abstract sessiontechnical
An oral abstract session is a scheduled conference presentation where researchers speak live about a summarized study or result selected from submitted abstracts, typically followed by expert questions. For investors it serves like an early product demo or progress update — providing timely insight into scientific or clinical progress, peer reaction, and potential regulatory or commercial implications that can influence a company’s prospects and stock value.
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BOTHELL, Wash.--(BUSINESS WIRE)--
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
Abstract Title
RINGSIDE: A phase 3 randomized, placebo-controlled trial of varegacestat for treatment of progressing desmoid tumors
Session Type/Title
Oral Abstract Session – Sarcoma
Date and Time
May 30, 2026, 3:00 PM–6:00 PM CDT
Presenter
Mrinal M. Gounder, M.D., Memorial Sloan Kettering Cancer Center
Abstract Number
11506
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.
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.
