Sellas Life Sciences Receives IDMC Recommendation to Continue Phase 3 REGAL Trial

Sellas Life Sciences receives IDMC recommendation to continue phase 3 REGAL trial in acute myeloid leukaemia

Overview

Sellas Life Sciences Group, Inc., a late-stage clinical biopharmaceutical company, announced a positive review of the ongoing phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukaemia (AML) by the Independent Data Monitoring Committee (IDMC). The IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. Based on a detailed analysis of all unblinded data, the IDMC projects with a high level of confidence that the interim analysis (60 events) will occur by the fourth quarter of 2024.

Words from CEO: Sellas

• “We are encouraged with another positive review and the IDMC’s recommendation to continue the phase 3 REGAL trial in AML without any modifications,” said Angelos Stergiou, MD, ScD hc, president and chief executive officer of Sellas. 
• “The committee’s review did not raise any safety or futility concerns, further strengthening our confidence in the potential of GPS as a safe and effective treatment option for AML patients. This is the first time the IDMC has provided guidance regarding the timing of the expected interim analysis, by the fourth quarter of this year, based on their thorough analysis of the REGAL trial data.”

From an Expert on REGAL Study

• “As a principal investigator from a high enrolling REGAL study site, I am of course delighted to learn that the interim analysis, a key milestone, is upcoming,” said Panagiotis Tsirigotis, MD, Professor of Medicine at the University of Athens and Chief of Leukaemia at Attikon University Hospital. 
• “What makes me equally and perhaps even more excited is that now with the REGAL study enrollment completed and upcoming efficacy read-out, I am looking forward to the potential expansion of GPS into other settings, beyond maintenance of second remissions in patients with AML, as it could function as a treatment modality in patients in first remission as well as post bone marrow transplant.”

About REGAL

• 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 responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the study's validity, scientific and clinical merits. 
• The IDMC charter provides for periodic reviews of safety, efficacy, and futility in addition to the interim and final analyses.

About Sellas

Sellas is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications.

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