SELLAS Life Sciences Group, Inc. announced that its pivotal Phase 3 REGAL trial evaluating galinpepimut-S, or GPS, in patients with acute myeloid leukemia has reached a pre-specified milestone of 80 total events, which refers to the number of recorded patient deaths. This threshold automatically triggers the final analysis of the study.
The REGAL trial, registered under the identifier NCT04229979, is an event-driven overall survival study structured as a randomized registrational clinical trial. With the occurrence of the 80th event, the company will initiate a database lock, unblind the study data, and conduct a statistical evaluation of the primary endpoint. Preliminary topline primary endpoint results from the trial are slated for release this quarter, in accordance with the study’s pre-specified statistical analysis plan.
Angelos Stergiou, President and Chief Executive Officer of SELLAS, characterized reaching the 80th event as a critical milestone for the program. He noted that acute myeloid leukemia remains an area of significant unmet medical need, particularly for patients who have achieved a second complete remission and face limited treatment options.
The trial evaluates GPS as a potential maintenance therapy for acute myeloid leukemia patients in second complete remission. While overall survival serves as the primary endpoint, the study also tracks secondary endpoints, including leukemia-free survival and other clinical outcomes.
GPS is the late-stage biopharmaceutical company’s lead product candidate, licensed from Memorial Sloan Kettering Cancer Center. The therapy targets the WT1 protein, which is expressed across a variety of tumor types, presenting potential applications as both a monotherapy and in combination with other treatments for hematologic malignancies and solid tumors. Beyond GPS, SELLAS is developing SLS009, a small molecule CDK9 inhibitor designed with reduced toxicity and increased potency compared to similar therapies, which has shown high response rates in patients carrying unfavorable prognostic factors such as ASXL1 mutations.
