Sellas Life Sciences announces IDMC completed interim analysis of REGAL trial

SELLAS Life Sciences (SLS) announced that Independent Data Monitoring Committee, IDMC, has completed pre-specified interim analysis of the Phase 3 REGAL trial of galinpepimut-S, GPS, in acute myeloid leukemia, AML. Following this interim analysis triggered by 60 events in the study population, the IDMC has recommended that the trial continue without modifications. The interim futility, efficacy, and safety analysis is designed to assess whether the therapy is safe, demonstrates potential efficacy, and merits continuation. The IDMC’s review of the interim data supports the continuation of the study according to its original protocol. Based on this positive evaluation, GPS has shown preliminary signals of effectiveness, allowing the trial to advance toward completion. The next and final analysis will be conducted once 80 events are reached, further determining the potential of GPS in addressing the needs of AML patients. SELLAS anticipates that 80 events will be reached this year.