Ascentage Pharma Receives Clearance from US FDA to Proceed with Phase III Clinical Trial for Lisaftoclax (APG-2575)

Ascentage Pharma has received clearance from the US Food and Drug Administration (FDA) to initiate a global Phase III study for their novel Bcl-2 inhibitor, lisaftoclax (APG-2575), in the treatment of patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) previously treated with a Bruton's tyrosine kinase inhibitor (BTKi).

The Phase III study, named APG2575CG301, is a significant step in the development of lisaftoclax as a potential treatment option for CLL/SLL patients who have relapsed or developed resistance to existing therapies, including BTKis.

The study is designed as a randomised-controlled trial and will be conducted across multiple centres globally. Its main focus will be to evaluate the efficacy and safety of combining lisaftoclax with a BTKi in this specific patient population.

Lisaftoclax is an orally administered small-molecule Bcl-2 selective inhibitor. Bcl-2 is a protein that plays a crucial role in regulating apoptosis, the process of programmed cell death. In cancer cells, overexpression of Bcl-2 can disrupt normal apoptosis and contribute to uncontrolled cell growth and survival. By targeting Bcl-2, lisaftoclax aims to restore the normal apoptotic process, leading to the elimination of cancer cells.

CLL/SLL is a type of leukaemia that predominantly affects adults. It is characterised by the abnormal accumulation of mature lymphocytes in the blood, bone marrow, and lymph nodes. Although current treatment options, such as immunotherapies, chemotherapies, and BTKis, can initially lead to positive responses in patients, relapse and drug resistance often emerge as significant challenges in managing the disease.

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