Sellas: Independent Data Monitoring Committee Recommends Phase 3 Leukemia Trial Continue

 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.

https://www.biospace.com/article/releases/sellas-life-sciences-independent-data-monitoring-committee-recommends-galinpepimut-s-regal-trial-to-continue-without-any-modifications/