FDA grants clearance to next phase of Ascentage Pharma’s clinical trial for CLL/SLL treatment

Betsy Goodfellow | August 8, 2023 | News story | Research and Development |  Ascentage Pharma, CLL/SLL, FDA, Oncology, clinical trial 

Ascentage Pharma has announced that the US Food and Drug Administration (FDA) has granted clearance for the phase 3 study of lisaftoclax (APG-2575) for the treatment of patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).

This clearance allows the company to take a step forward in the global development of the drug, marking another milestone after the approval of a phase 2 study by the Center for Drug Evaluation (CDE) in China.

The global, multi-centre, randomised, registrational phase 3 study (APG2575CG301) is intended to evaluate the safety and efficacy of lisaftoclax plus a Bruton’s tyrosine kinase inhibitor (BTKi) in patients with CLL/SLL who were previously treated with BTKi. The study is set to begin in the second half of 2023.

Dr Yifan Zhai, chief medical officer of Ascentage Pharma, commented: “With progress in the research and development of targeted therapies, we have seen considerable improvement to the survival of patients with CLL/SLL. However, there remain major clinical challenges and urgent unmet medical needs for novel therapies that are safe and effective. Lisaftoclax, a key drug candidate of our apoptosis-targeted pipeline with global best-in-class potential, has shown promising efficacy and favourable safety in earlier studies. We are very encouraged by the FDA’s clearance for the global registrational phase 3 study as it marks a major milestone in the development of lisaftoclax. Fulfilling the mission of addressing unmet clinical needs in China and around the world, we will press ahead with the global registrational phase 3 study of lisaftoclax (APG-2575) to allow patients around the world to benefit from this novel therapeutic as soon as possible.”

Betsy Goodfellow