On December 8, 2022 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 that the Independent Data Monitoring Committee (IDMC) for its Phase 3 REGAL study for galinpepimut-S (GPS) in acute myeloid leukemia (AML) performed its initial prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications (Press release, Sellas Life Sciences, DEC 8, 2022, View Source [SID1234624959]). The charter for the IDMC provides for periodic reviews by the IDMC for safety, efficacy and futility in addition to the interim and final analyses.
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The REGAL study 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 (OS). 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 the REGAL trial, and for monitoring the quality and overall conduct to ensure the validity, scientific and clinical merits of the study.
"Following a prespecified review of unblinded data by the IDMC in accordance with its charter, its recommendation to continue the REGAL study as is, and with trial conduct and integrity intact, is outstanding news. As we have previously reported, we have seen, based on a blinded review of the data conducted this fall, that patients live longer than expected which triggered modifications to the statistical analysis plan (SAP), in particular to reduce the number of events for the interim and final analyses, which is very encouraging," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.