By Fineline Cube 
Ascentage Pharma Group International (HKG: 6855) announced that it has received clearance from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to initiate the GLORA-4 study (NCT06641414), a global registrational Phase III trial of Lisaftoclax (APG-2575) in combination with azacitidine (AZA). The study targets patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).
Drug Profile
Lisaftoclax is a novel, orally administered Bcl-2 selective inhibitor developed by Ascentage Pharma. It works by selectively blocking the anti-apoptotic protein Bcl-2, thereby restoring normal apoptosis in cancer cells. Lisaftoclax is already approved in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy, including Bruton’s tyrosine kinase (BTK) inhibitors.
Clinical Trial Details
The GLORA-4 study is a multi-region, multi-center, randomized, double-blind Phase III trial. It aims to evaluate the efficacy and safety of Lisaftoclax in combination with AZA compared to placebo plus AZA in newly diagnosed adult patients with HR-MDS. The trial was originally approved by China’s Center for Drug Evaluation (CDE) in 2024 and is now enrolling patients at participating centers across multiple countries.-Fineline Info & Tech