Ascentage Pharma, a global biopharmaceutical company focused on developing innovative treatments for cancer, chronic hepatitis B (CHB), and age-related diseases, has announced a significant clinical collaboration with AstraZeneca Investment (China) Co., Ltd. This collaboration is centered around conducting a Phase III study of APG-2575 (lisaftoclax), a Bcl-2 inhibitor developed by Ascentage Pharma, in combination with AstraZeneca's Bruton's tyrosine kinase (BTK) inhibitor, CALQUENCE® (acalabrutinib). The study will focus on treatment-naive patients with first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

This global, multi-center, randomized-controlled, Phase III trial aims to evaluate the effectiveness and safety of lisaftoclax combined with acalabrutinib compared to immunochemotherapy in treatment-naïve CLL/SLL patients.

This collaboration builds on a previous Phase II study conducted in partnership with Acerta Pharma, a subsidiary of AstraZeneca. In that study, the lisaftoclax and acalabrutinib combination demonstrated strong therapeutic potential, with impressive response rates in patients with CLL/SLL and a favorable safety profile.

CLL/SLL is a common hematologic malignancy affecting adults, particularly in the Western world. In China, it's increasingly prevalent and more aggressive, presenting a significant health threat. Despite advancements in targeted therapies, there's a pressing need for treatments that offer both efficacy and safety.

Lisaftoclax is a novel Bcl-2 selective inhibitor developed by Ascentage Pharma. It's designed to block the antiapoptotic protein Bcl-2, thereby restoring the normal apoptosis process in cancer cells. Acalabrutinib, on the other hand, is a highly selective BTK inhibitor. This partnership represents an essential step toward offering patients in China more effective and safer treatments for hematologic malignancies.

This collaboration signifies a commitment to addressing unmet clinical needs in the field of cancer treatment. Results from ongoing clinical studies suggest that the combination of lisaftoclax and acalabrutinib holds significant therapeutic potential. Both companies are dedicated to advancing this clinical development program to benefit a broader population of patients and bring innovative therapies to the forefront.

In a rapidly evolving field like oncology, partnerships between biopharmaceutical companies are essential for advancing treatments and improving patient outcomes. This collaboration reflects a commitment to innovation and improving the lives of those affected by hematologic malignancies.