SEELAS Life Sciences (US:SLS) Globenewswire·2025-12-29 13:35Core Viewpoint - SELLAS Life Sciences Group, Inc. is advancing its Phase 3 REGAL trial for GPS as a potential maintenance therapy in patients with acute myeloid leukemia (AML) after second complete remission, with the trial currently reporting 72 events as of December 26, 2025, and awaiting the 80 events needed for final analysis [1][3][7] Group 1: Trial Update - The Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 REGAL trial continue without modification, with expectations that the required 80 events (deaths) for final analysis would occur before year-end [2] - As of December 26, 2025, the trial has recorded 72 events, and SELLAS remains blinded to all efficacy and survival data outcomes, meaning this update does not affect future statistical analyses [3][7] - The final analysis is event-driven, and the company will announce when the 80th event occurs [3][7] Group 2: Company Commitment and Expert Insights - The CEO of SELLAS expressed appreciation for the dedication of participants in the REGAL trial, noting that survival times appear longer than expected, which may increase the probability of a successful study [4] - Dr. Yair Levy, a member of the REGAL Steering Committee, highlighted the significance of the REGAL study in evaluating GPS for AML patients who cannot undergo transplant, with an expected median overall survival of around eight months for current treatments [4] - The company is committed to advancing breakthrough therapies like GPS that have the potential to significantly improve patient outcomes in AML [4] Group 3: About the REGAL Trial - The REGAL trial (NCT04229979) is a Phase 3 randomized registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy [5] - The primary endpoint of the trial is overall survival, and the IDMC is responsible for monitoring patient safety and efficacy data [5] Group 4: About SELLAS Life Sciences - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapeutics for various cancer indications, with its lead product candidate GPS targeting the WT1 protein present in multiple tumor types [6] - The company is also developing SLS009, a differentiated small molecule CDK9 inhibitor, which has shown a high response rate in AML patients with unfavorable prognostic factors [8]