Sellas Life Sciences Group, Inc. (SLS) announced positive interim results from their Phase 3 REGAL trial of galinpepimut-S (GPS) for treating acute myeloid leukemia. The Independent Data Monitoring Committee (IDMC), after evaluating 60 deaths within the study group, recommended that the trial proceed without any changes.
The analysis revealed that less than half of the enrolled participants had died after a median follow-up of 13.5 months. This suggests a median survival rate surpassing 13.5 months, compared to a historical median survival rate of 6 months with standard treatment.
Moreover, in a random sample of GPS patients, 80% demonstrated a specific T-cell immune response, outperforming results from the earlier Phase 2 study.
The conclusion of the study's final analysis will occur upon reaching 80 death events, anticipated later this year. Sellas Life Sciences is also preparing to submit a Biologics License Application.
As of now, shares of SELLAS have decreased by 14.61%, trading at $0.97 on the Nasdaq.
