Ascentage Pharma has received clearance from the US Food and Drug Administration (FDA) to begin a Phase III study evaluating lisaftoclax (APG-2575) in patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) who previously received Bruton’s tyrosine kinase inhibitor (BTKi).

The international, registrational, randomised-controlled, multi-centre study intends to assess the safety and efficacy of the oral Bcl-2 selective inhibitor lisaftoclax along with BTKi.

It is anticipated to begin in the second half of this year.

A similar 19 clinical studies of the therapy were carried out that treated more than 600 patients, including more than 300 CLL/SLL patients.

Ascentage Pharma chief medical officer Dr Yifan Zhai said: “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 III study as it marks a major milestone in the development of lisaftoclax.

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“Fulfilling the mission of addressing unmet clinical needs in China and around the world, we will press ahead with the global registrational Phase III study of lisaftoclax (APG-2575) to allow patients around the world to benefit from this novel therapeutic as soon as possible.”

In December 2021, the Center for Drug Evaluation (CDE) approved the registrational Phase II study in China.

Objective response rates (ORRs) of 100% (16/16) in treatment-naive patients and 98% (56/57) in relapsed/refractory patients were observed. They received the lisaftoclax monotherapy along with BTKi acalabrutinib.

Compared to lisaftoclax, the combination regimens showed a significant safety profile and a low incidence of tumour lysis syndrome (TLS).

Lisaftoclax selectively blocks the antiapoptotic protein Bcl-2 thereby restoring the normal apoptosis process in cancer cells.

The company is also engaged in developing various therapeutics, including dual Bcl-2/Bcl-xL inhibitors, candidates targeting IAP and MDM2-p53 pathways, and TKIs for treating chronic hepatitis B, and age-related diseases along with cancers.