SELLAS Life Sciences (NYSE:SLS) said it is approaching the final analysis milestone in its pivotal Phase 3 REGAL trial evaluating galinpepimut-S (GPS) in acute myeloid leukemia, following an aggregate event count update from its contract research organization.
The company said the CRO reported 72 pooled events, defined as deaths, as of Dec. 26, 2025.
The event-driven trial requires 80 events to trigger the final overall survival analysis.
SELLAS said it remains fully blinded to individual efficacy and survival outcomes and that the aggregate event update does not affect the trial’s prespecified statistical analysis plan.
The company said it will announce when the 80th event has occurred.
The update follows a prior review by the Independent Data Monitoring Committee, which recommended that the REGAL trial continue without modification.
The study is designed to evaluate whether GPS can improve overall survival in patients with acute myeloid leukemia, a hematologic malignancy with high relapse rates and limited long-term treatment options.