Sellas Life Sciences announces positive review of ongoing Phase 3 REGAL trial

SELLAS Life Sciences 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 conducted a prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications, and scheduled its next meeting in June 2024, earlier than prescribed in the IDMC charter schedule to review the most up-to-date information regarding the number of events required for triggering prespecified interim analysis. “We thank the IDMC members for the work and their guidance to continue the Phase 3 REGAL trial patients’ treatment without any modifications,” said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. “This recommendation was made based on the assessment of efficacy and safety of the accumulated data. We are pleased with the recently concluded enrollment for the study in the US, Europe, and Asia, per the predetermined statistical analysis plan, and we look forward to the interim analysis potentially later this quarter. If approved, GPS would be a promising new treatment in this severely underserved indication.”