Sellas Life Sciences Group Triggers Interim Analysis in Phase 3 REGAL Trial for Galinpepimut-S in AML

Sellas Life Sciences Group, Inc. recently disclosed a significant development in its clinical trial progress. The company announced the initiation of an interim analysis by the Independent Data Monitoring Committee (IDMC) for the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML). This announcement was made through a press release and a subsequent webcast held on December 10, 2024.

The IDMC, an independent entity overseeing the study, is set to evaluate the ongoing Phase 3 REGAL trial, which marks a crucial step in assessing the potential of GPS as a treatment option for AML. The Company hosted a webcast to discuss the process leading up to the IDMC meeting and the potential outcomes of the interim analysis.

The disclosure made under Item 7.01 Regulation FD Disclosure included the press release and the transcript of the webcast, emphasizing the forward-looking statements regarding the GPS clinical development program and milestones. Such statements are based on existing plans, objectives, and risks associated with oncology product development and regulatory approval.

The REGAL study enrolled 126 AML patients, and the interim analysis was triggered by the occurrence of 60 predefined events. A conservative statistical approach will be used to maintain the trial’s integrity and confirm any potential efficacy.

The Company anticipates the IDMC’s meeting in January, where discussions on efficacy, futility, and safety analyses will take place based on the interim data. The ultimate goal is to deliver novel, impactful solutions in oncology, demonstrating the Company’s commitment to advancing cancer therapeutics.

Results from the interim analysis will guide the next steps in the REGAL trial, potentially leading to recommendations to halt the study due to exceptional efficacy or continue towards the final analysis at 80 events. The Company will adhere to regulatory procedures and provide updates to stakeholders as per protocol.

Sellas Life Sciences Group remains dedicated to its mission of developing innovative treatments and remains optimistic about the future implications of the ongoing REGAL study on AML patients. The commitment to transparency and regulatory compliance underscores the Company’s pledge to advancing cancer research and delivering promising therapeutic outcomes.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read SELLAS Life Sciences Group’s 8K filing here.

SELLAS Life Sciences Group Company Profile

SELLAS Life Sciences Group, Inc, a late-stage clinical biopharmaceutical company, focuses on the development of novel cancer immunotherapies for various cancer indications in the United States. The company’s lead product candidate is galinpepimut-S (GPS), a cancer immunotherapeutic agent that targets Wilms tumor 1, which is in Phase 3 clinical trials for the treatment of acute myeloid leukemia; and in Phase 1/2 clinical trials for the treatment for ovarian cancer.