FAQ on Ascentage Pharma's GLORA-4 Phase III Trial of Lisaftoclax for Blood Cancer
Summary
Ascentage Pharma has initiated the GLORA-4 Phase III trial for lisaftoclax, a Bcl-2 inhibitor, in combination with azacitidine for treating higher-risk myelodysplastic syndrome (HR-MDS), marking a significant step towards addressing a major unmet medical need in blood cancer treatment.
What is the GLORA-4 Phase III trial about?
The GLORA-4 Phase III trial is a global study evaluating the efficacy and safety of lisaftoclax in combination with azacitidine for treating newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).
Why is the GLORA-4 trial significant?
This trial is significant because it aims to address the lack of targeted therapies for first-line treatment of HR-MDS, potentially becoming the first Bcl-2 inhibitor approved globally for this indication.
How does lisaftoclax work in treating HR-MDS?
Lisaftoclax is a Bcl-2 inhibitor that has shown promising clinical benefit and tolerability in earlier studies, targeting the disease at a molecular level.
Who is conducting the GLORA-4 trial?
Ascentage Pharma is conducting the trial, with Dr. Yifan Zhai as the Chief Medical Officer, and it involves global co-leading principal investigators from prestigious institutions.
Where is the GLORA-4 trial being conducted?
The trial is being conducted simultaneously in China, the U.S., and Europe, with patients already enrolled in China and Europe.
When did the GLORA-4 trial receive clearance?
The trial received clearance by the U.S. FDA and EMA, coinciding with approval by the China CDE in 2024.
What are the potential benefits of the GLORA-4 trial?
If positive, the trial could end the longstanding treatment gap in HR-MDS and reshape the treatment landscape with the first targeted therapy since the introduction of hypomethylating agents.
How does lisaftoclax compare to current treatment options for HR-MDS?
Current options include hypomethylating agents and allogeneic hematopoietic stem cell transplantation, but lisaftoclax offers a targeted approach with potential for better efficacy and tolerability.
Who can participate in the GLORA-4 trial?
Newly diagnosed adult patients with higher-risk MDS are eligible to participate in the trial at participating centers globally.
How can I find more information about the GLORA-4 trial?
For more information, you can visit Ascentage Pharma’s website or contact the participating centers in China, the U.S., and Europe.
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