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SELLAS Life Sciences Independent Data Monitoring Committee Recommends Galinpepimut-S REGAL Trial to Continue Without any Modifications
REGAL Interim Analysis Expected by Late 2023/Early 2024 Enrollment Expected to be Completed in Q4 2023 NEW YORK, Aug. 22, 2023 (GLOBE NEWSWIRE) -- SELLAS Life
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"REGAL Interim Analysis Expected by Late 2023/Early 2024 Enrollment Expected to be Completed in Q4 2023 NEW YORK, Aug. 22, 2023 (GLOBE NEWSWIRE) -- 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, today announced 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). The IDMC performed a routine, prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. While the interim analysis is event driven per the protocol (60 events), based upon the Company’s statistical assumptions, the interim analysis is expected to occur by late 2023 or early 2024. The Company anticipates that enrollment in the study will be completed during Q4 2023. The IDMC is scheduled to meet again within Q4 2023. “At its most recent meeting, we were pleased that the IDMC positively commented on the high level of study integrity and conduct, as well as the rate of enrollment to date. We look forward to the anticipated completion of enrollment in Q4, as well as the subsequent interim analysis, both significant milestones for our GPS development program,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. 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. About SELLAS Life Sciences Group, Inc. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan ...