Ascentage Pharma Advances HR-MDS Treatment with FDA & EMA-Cleared Phase III Trial

Ascentage Pharma, a global biopharmaceutical company, has received clearance from the U.S. FDA and the European Medicines Agency to conduct the GLORA-4 study, a global registrational Phase III trial of lisaftoclax in combination with azacitidine for treating newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). This study aims to address the significant unmet medical need in HR-MDS treatment, with lisaftoclax being the only Bcl-2 inhibitor in a registrational Phase III trial for this condition globally. The study's success could revolutionize the treatment landscape for HR-MDS, offering hope for improved patient outcomes.

The GLORA-4 trial is a multi-region, multi-center study designed to evaluate the efficacy and safety of lisaftoclax combined with AZA compared to placebo plus AZA. It is being conducted in China, the U.S., and Europe, with the first patients already enrolled in China and Europe. The study's global co-leading principal investigators include Dr. Guillermo Garcia-Manero and Prof. Xiaojun Huang, highlighting the international collaboration and significance of this research. Preliminary data from earlier studies showed promising clinical benefits and tolerability, with an overall response rate of 75%, significantly higher than current treatments.