Sellas Life Sciences Updates Pivotal Phase 3 REGAL Trial of Galinpepimut-S in Acute Myeloid Leukemia
Sellas Life Sciences Group, Inc. (NASDAQ: SLS) provided a progress update on its ongoing pivotal Phase 3 REGAL clinical trial evaluating galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML). The REGAL trial is designed to assess whether GPS can help reduce the risk of relapse and improve outcomes in AML patients who have achieved remission but remain at high risk for disease recurrence.
Trial Design and Purpose
The REGAL study is a randomized, controlled Phase 3 trial comparing galinpepimut-S plus best supportive care to best supportive care alone. Galinpepimut-S is a peptide-based immunotherapy intended to stimulate a patient’s immune system to recognize and attack residual leukemia cells after remission. The goal of the trial is to demonstrate that this immune-driven approach can extend relapse-free survival—a key clinical benchmark in AML.
Patients enrolled in the study have completed initial induction and consolidation therapy, placing them in a remission state but with measurable residual disease or other factors associated with higher relapse risk. The trial’s primary endpoint focuses on relapse-free survival, with secondary endpoints including overall survival and safety.
Enrollment Progress and Operational Update
Sellas reported that patient enrollment continues to progress steadily, and the trial remains on track with its recruitment timeline. The company also highlighted ongoing efforts to ensure high-quality data collection and site performance across participating clinical centers.
Leadership emphasized that meeting enrollment targets is essential for maintaining the planned statistical power of the study and for preserving the integrity of future efficacy analyses.
Strategic Importance of REGAL
Acute myeloid leukemia is an aggressive blood cancer with high rates of relapse, particularly in patients who are older or unable to proceed to stem cell transplant. Currently available post-remission options are limited, and there remains a significant need for therapies that can meaningfully reduce recurrence risk.
Galinpepimut-S represents an immunotherapy strategy designed to harness the immune system against residual disease, potentially offering a novel therapeutic angle beyond cytotoxic chemotherapy or targeted small molecules.
What’s Next
With enrollment continuing, Sellas is focused on completing patient recruitment and advancing the trial toward its data readouts. Investors and industry observers will be watching for future milestones, such as enrollment completion and interim or topline results, which could inform regulatory planning and broader clinical adoption.
