Promising Results in Leukemia Trial: New Hope for AML Patients

Introduction

SELLAS Life Sciences has announced a positive review from the Independent Data Monitoring Committee (IDMC) for their Phase 3 REGAL trial investigating galinpepimut-S (GPS) in acute myeloid leukemia (AML). The IDMC’s recommendation to continue the trial without any modifications signifies a crucial step forward in the development of this novel treatment.

Phase 3 REGAL Trial Details

The REGAL trial is a Phase 3, open-label study designed to evaluate the efficacy of GPS in AML patients who have achieved complete remission following second-line salvage therapy. The primary endpoint of the trial is overall survival, aiming to provide a potential new therapy for patients in this critical condition.

The IDMC, an independent group of medical and scientific experts, has conducted an in-depth risk-benefit assessment of the unblinded data from the ongoing study. Their positive recommendation underscores the potential effectiveness and safety of GPS as a treatment for AML.

No Safety or Futility Concerns

One of the major highlights of the IDMC’s review is that no safety or futility concerns were raised based on the data analyzed. This is an encouraging sign, suggesting that GPS may indeed offer a safe and effective treatment for AML patients.

SELLAS’ President and CEO, Dr. Angelos Stergiou, expressed his optimism following the review, stating that the continued positive findings bolster the company’s confidence in GPS’s potential as a novel therapeutic option.

Upcoming Interim Analysis

The IDMC has also indicated that an interim analysis is anticipated by the fourth quarter of 2024. This analysis will be a critical milestone in the REGAL trial, potentially providing further insights into the efficacy of GPS.

Dr. Panagiotis Tsirigotis, a principal investigator at a high enrolling REGAL study site, highlighted the importance of the upcoming interim analysis, expressing excitement about the potential expansion of GPS into additional treatment settings for AML patients.

Potential Broader Applications

GPS’s application may extend beyond its current use in maintaining second remissions in AML patients. Future developments could see GPS being utilized as a treatment modality for patients in their first remission and post bone marrow transplant, expanding its therapeutic reach.

With its potential to address a broad spectrum of hematologic malignancies and solid tumor indications, GPS represents a significant advancement in cancer therapy. As research progresses, the potential for broader applications in various cancer settings remains a key area of interest.

About SELLAS Life Sciences

SELLAS Life Sciences is a late-stage clinical biopharmaceutical company focused on developing innovative cancer therapies. The company’s lead product, GPS, targets the WT1 protein, prevalent in numerous tumor types.

In addition to GPS, SELLAS is also developing a highly selective CDK9 inhibitor, SLS009, licensed from GenFleet Therapeutics. The company's commitment to novel cancer treatments highlights its significant contributions to the field of oncology.