Sellas Life Sciences says IDMC recommends continuation of REGAL trial

SELLAS Life Sciences Group announced a positive review of the ongoing Phase 3 REGAL clinical trial of galinpepimut-S in acute myeloid leukemia by the Independent Data Monitoring Committee. The IDMC performed a routine, prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. While the interim analysis is event driven per the protocol, based upon the Company’s statistical assumptions, the interim analysis is expected to occur by late 2023 or early 2024. The Company anticipates that enrollment in the study will be completed during Q4 2023. The IDMC is scheduled to meet again within Q4 2023. REGAL is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy. The primary endpoint is overall survival. The IDMC is an independent group of medical, scientific and biostatistics experts who are responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the validity, scientific and clinical merits of the study. The IDMC charter provides for periodic reviews for safety, efficacy, and futility in addition to the interim and final analyses.