SELLAS Life Sciences Reports Promising Phase 3 AML Trial Results

NEW YORK, Jan. 23, 2025 — SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced positive interim results from its Phase 3 REGAL trial evaluating galinpepimut-S (GPS) for acute myeloid leukemia (AML). The Independent Data Monitoring Committee (IDMC) recommended the trial continue without modifications after reviewing data from 60 death events.

The interim analysis revealed that fewer than 50% of enrolled patients had died after a median follow-up of 13.5 months, suggesting a median survival exceeding 13.5 months compared to the historical 6-month survival rate with conventional therapy. Additionally, 80% of randomly selected GPS patients demonstrated a specific T-cell immune response, surpassing results from previous Phase 2 trials.

“I am thrilled by the positive outcome of the interim analysis,” said Dr. Angelos Stergiou, President and CEO of SELLAS. “This brings us one step closer to potential approval for AML treatment, offering hope to patients with limited options.”

The REGAL trial focuses on AML patients in second complete remission (CR2) following second-line salvage therapy. No drug has been approved specifically for maintaining remission in CR2 AML patients, highlighting the significance of GPS’s potential. The final analysis is expected later this year after reaching 80 death events.

Dr. Yair Levy, Director of Hematologic Malignancies Research at Texas Oncology Baylor University Medical Center, emphasized the importance of the findings. “GPS has shown minimal side effects, which is critical given that up to 60% of patients on standard therapies experience severe side effects,” he said.

SELLAS is preparing for a Biologics License Application (BLA) submission, aiming to establish GPS as a transformative treatment for AML. The company remains blinded to trial outcomes to maintain study integrity but is optimistic about the final results.