IDMC Endorses Unmodified Continuation of SELLAS' REGAL Phase 3 Post-Enrollment

SELLAS Life Sciences Group, a clinical-stage biopharmaceutical firm, has received a favorable assessment of its Phase 3 REGAL clinical trial for galinpepimut-S (GPS), a therapy for acute myeloid leukemia (AML). The Independent Data Monitoring Committee (IDMC) has reviewed the unblinded data and has advised that the trial should proceed without any changes. The IDMC's next meeting has been scheduled for June 2024 to review the latest data regarding the number of events needed to trigger an interim analysis.

The company's President and CEO, Angelos Stergiou, expressed gratitude to the IDMC for their guidance and the decision to continue the trial without alterations. He highlighted the recent completion of patient enrollment in the US, Europe, and Asia and anticipated the interim analysis later in the quarter. If approved, GPS could become a significant new treatment for AML, a condition with limited treatment options.

As of March 2024, the REGAL Study Steering Committee had reviewed the data with 66 patients discontinuing treatment. The trial records patients as having stopped treatment due to death, relapse, intolerable toxicity, or treatment completion. So far, no intolerable toxicities have been observed in any patient population in the GPS arm, which is a notable contrast to the control arm where toxicities are common. The IDMC confirmed no safety concerns in their recent review. The actual number of events is unclear, but the IDMC will review both efficacy and safety data from all enrolled REGAL patients in June.

The REGAL trial is an open-label study for AML patients who have achieved complete remission after second-line salvage therapy. The primary goal is to assess overall survival. The IDMC is a group of experts who evaluate patient safety and efficacy data, ensuring the study's validity and clinical merits. They conduct periodic reviews in addition to interim and final analyses.

SELLAS is developing GPS, licensed from Memorial Sloan Kettering Cancer Center, which targets the WT1 protein found in various tumor types. GPS has the potential for use as a monotherapy or in combination with other treatments for a range of cancers. The company is also developing SLS009, a CDK9 inhibitor licensed from GenFleet Therapeutics for therapeutic and diagnostic uses outside of Greater China.

The company's lead product, GPS, offers hope for patients with AML and other cancers. SELLAS continues its commitment to developing innovative therapies, with the REGAL trial being a key part of its clinical development program. The company looks forward to the upcoming interim analysis and the potential approval of GPS as a new treatment option.