SELLAS Life Sciences Announces Positive Recommendation from the Independent Data Monitoring Committee of the Phase 3 REGAL Trial in Acute Myeloid Leukemia

Core Insights - SELLAS Life Sciences Group, Inc. announced a positive review of the Phase 3 REGAL clinical trial for galinpepimut-S (GPS) in acute myeloid leukemia (AML) by the Independent Data Monitoring Committee (IDMC), which recommended the trial continue without modifications [1][7] - The IDMC's assessment indicated no safety or futility concerns, enhancing confidence in GPS as a potential treatment for AML patients [7] - An interim analysis is anticipated by the fourth quarter of 2024, with the IDMC projecting a high level of confidence in this timeline based on unblinded data [1][7] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications, with GPS being a lead product candidate licensed from Memorial Sloan Kettering Cancer Center [9] - GPS targets the WT1 protein, which is present in multiple tumor types, and has potential as both a monotherapy and in combination with other therapies for hematologic malignancies and solid tumors [9] - The company is also developing SLS009, a selective CDK9 inhibitor licensed from GenFleet Therapeutics for global therapeutic and diagnostic uses outside Greater China [9] Clinical Trial Details - The REGAL trial is an open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy [8] - The primary endpoint of the trial is overall survival, and the IDMC is responsible for monitoring patient safety and efficacy data, ensuring the study's validity and scientific merit [8]