On December 4, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported a positive review of the ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) by the Independent Data Monitoring Committee (IDMC) (Press release, Sellas Life Sciences, DEC 4, 2023, View Source [SID1234638132]). The IDMC performed a routine, prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. The IDMC also requested that the survival database be updated immediately prior to the next IDMC meeting, which will take place in Q1 2024, and be provided to the IDMC for its review at the meeting.
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"We are very encouraged by the IDMC’s recommendations to continue the Phase 3 trial without any modifications as well as positive commentary on the high level of study integrity and conduct and their request of an ad hoc database update that could potentially expedite their review and analyses of all current survival and safety data," said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer at SELLAS. "This review comes on the heels of reaching our patient enrollment target, ex-China, and we very much look forward to the IDMC’s next meeting in the first quarter of 2024. We believe that, based on its unique mechanism of action, GPS may offer a promising new treatment option to patients with AML."
REGAL is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival. The IDMC is an independent group of medical, scientific, and biostatistics experts who are responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the validity, scientific and clinical merits of the study. The IDMC charter provides for periodic reviews for safety, efficacy, and futility in addition to the interim and final analyses.