Independent Data Monitoring Committee recommends galinpepimut-S REGAL trial to continue as planned- Sellas Life Sciences
SELLAS Life Sciences announced that the Independent Data Monitoring Committee (IDMC) for its Phase III 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.
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.
The REGAL study is a Phase III 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.
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