NEW YORK, August 7, 2025 — Leads & Copy — SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced that the Independent Data Monitoring Committee (IDMC) has completed a pre-specified analysis of the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) and has recommended continuing the trial without modification.
The IDMC concluded that the risk-benefit profile of GPS supports continued evaluation under the current study protocol. No safety concerns were identified, and available efficacy data were consistent with expectations for continued trial conduct. The study completed enrollment in April 2024, with 126 patients randomized. Study sites in the U.S. and Europe accounted for approximately 75% of patients enrolled.
The next and final analysis will be triggered once 80 events (deaths) have occurred, further determining the potential of GPS in addressing the needs of AML patients. The Phase 3 REGAL trial is a survival-driven study for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival.
John Fraunces, Managing Director, LifeSci Advisors, LLC, jfraunces@lifesciadvisors.com
Source: SELLAS Life Sciences Group, Inc.
