Sellas Life Sciences' GPS Trial Continues with Positive IDMC Recommendation

Sellas Life Sciences announced that the Independent Data Monitoring Committee has completed a pre-specified analysis of the Phase 3 REGAL trial of galinpepimut-S in acute myeloid leukemia. The IDMC found no safety concerns and available efficacy data consistent with expectations, recommending continued trial conduct. The study completed enrollment in April 2024, with a total of 126 patients randomized.

Title: SELLAS Life Sciences Receives Positive IDMC Recommendation to Continue Phase 3 REGAL Trial of Galinpepimut-S in AML

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) has received a positive recommendation from the Independent Data Monitoring Committee (IDMC) to continue its Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML). The IDMC concluded that the risk-benefit profile of GPS supports continued evaluation under the current study protocol, with no safety concerns and available efficacy data consistent with expectations [1].

The Phase 3 REGAL trial, which completed enrollment in April 2024 with 126 patients, predominantly recruited from U.S. and European sites, aims to determine the potential of GPS in addressing the needs of AML patients. The study is a survival-driven trial, and the next and final analysis will be triggered once 80 events (deaths) have occurred, further determining the potential of GPS in AML treatment [2].

SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. The company’s lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications [3].

The IDMC, an independent group of medical, scientific, and biostatistics experts, is responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring the quality and overall conduct to ensure the validity, scientific, and clinical merits of the study. The IDMC charter provides for periodic reviews of safety, efficacy, and futility in addition to the interim and final analyses [1].

SELLAS Life Sciences is also developing SLS009 (tambiciclib), a potentially first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation [3].

References:
[1] https://www.stocktitan.net/news/SLS/sellas-life-sciences-announces-independent-data-monitoring-committee-dgztlxe65e4z.html
[2] https://www.nasdaq.com/articles/sellas-life-sciences-gets-positive-idmc-nod-continue-phase-3-trial-aml-treatment
[3] https://www.globenewswire.com/news-release/2025/08/07/3129257/0/en/SELLAS-Life-Sciences-Announces-Independent-Data-Monitoring-Committee-Periodic-Review-and-Positive-Recommendation-to-Continue-Pivotal-Phase-3-REGAL-Trial-of-GPS-in-AML-Without-Modif.html