SELLAS Life Sciences Group, Inc. (SLS), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, Thursday announced that the Independent Data Monitoring Committee (IDMC) has completed a pre-specified analysis of the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML), and has issued a positive recommendation to continue the trial without modification.
The IDMC concluded that the risk-benefit profile of GPS supports continued evaluation under the current study protocol. No safety concerns were identified, and available efficacy data were consistent with expectations for continued trial conduct.
The study completed enrollment in April 2024, with a total of 126 patients randomized. Study sites in the U.S. and Europe accounted for approximately 75% of patients enrolled, with the U.S.-based sites representing the highest enrolling country.
The Phase 3 REGAL trial is a survival-driven study, and the next and final analysis will be triggered once 80 events (deaths) have occurred, further determining the potential of GPS in addressing the needs of AML patients. As of the time of this IDMC review, that threshold has not yet been reached.
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