Ascentage Pharma and Astrazeneca Collaborate on Phase III Study for First-line CLL/SLL Treatment With Bcl-2 Inhibitor Lisaftoclax and BTK Inhibitor Acalabrutinib

Ascentage Pharma (6855.HK), a global biopharmaceutical company dedicated to developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that it has initiated a clinical collaboration with AstraZeneca Investment (China) Co., Ltd. The partnership aims to jointly conduct a registrational Phase III study for the Bcl-2 inhibitor, APG-2575 (lisaftoclax), in combination with AstraZeneca's Bruton's tyrosine kinase (BTK) inhibitor, CALQUENCE® (acalabrutinib), in treatment-naive patients with first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

The Phase III confirmatory trial is designed as a global, multi-center, randomized-controlled, open-label study, intending to assess the efficacy and safety of lisaftoclax combined with acalabrutinib compared to immunochemotherapy in treatment-naïve CLL/SLL patients.

This collaboration is a significant step in the joint clinical development of the lisaftoclax and acalabrutinib combination by Ascentage Pharma and AstraZeneca. In June 2020, Ascentage Pharma collaborated with Acerta Pharma, a research and development center of the AstraZeneca Group, to conduct a global Phase II study. This study aimed to evaluate the safety, tolerability, and efficacy of lisaftoclax, Ascentage Pharma's Bcl-2 selective inhibitor, in combination with acalabrutinib, Acerta Pharma's BTK inhibitor. The study yielded promising results, with an objective response rate (ORR) of 98% in patients with relapsed/refractory CLL/SLL, 100% in treatment-naïve patients with CLL/SLL, and a favorable safety profile, similar to lisaftoclax monotherapy. These findings were presented at the 2022 American Society of Hematology (ASH) Annual Meeting.

CLL/SLL is a hematologic malignancy that primarily affects older populations and ranks among the most common leukemia subtypes in adults. It accounts for a significant proportion of leukemia cases in the Western world, with over 100,000 new diagnoses worldwide annually. In China, the incidence of CLL/SLL is rising rapidly, with a younger age of onset and increased aggressiveness, posing a substantial public health challenge. Although basic research and targeted therapies have improved survival rates for CLL/SLL patients, significant clinical challenges persist, necessitating new treatment options that offer both efficacy and safety.

Lisaftoclax, an orally administered Bcl-2 selective inhibitor developed by Ascentage Pharma, selectively inhibits the antiapoptotic protein Bcl-2, thereby restoring the normal apoptosis process in cancer cells. Lisaftoclax is currently undergoing evaluation in multiple clinical studies worldwide, with interim results indicating potent efficacy in patients with CLL/SLL, whether used as a monotherapy or in combination regimens. In August 2023, the US Food and Drug Administration (FDA) cleared lisaftoclax for participation in a global registrational Phase III study to assess its efficacy and safety when combined with a BTK inhibitor in patients with CLL/SLL who have received previous therapies.

Acalabrutinib, a highly selective BTK inhibitor, is widely recognized as a standard of care for CLL patients. It received US FDA approval for mantle cell lymphoma (MCL) and CLL/SLL in 2017 and 2019, respectively. The drug has been approved in over 50 countries/regions, including the European Union and Japan. This year in China, acalabrutinib received sequential approvals for MCL patients who had received at least one prior therapy and for adult patients with CLL/SLL who had received at least one prior therapy.

Ascentage Pharma, emphasized the significance of combining Bcl-2 inhibitors and BTK inhibitors in the treatment of CLL/SLL. Results from the global Phase II study of lisaftoclax combined with acalabrutinib suggest its potential as a patient-centric treatment with significant therapeutic promise. He stressed the need for safer and more effective Bcl-2 inhibitors in China to address the clinical needs of patients.

AstraZeneca China, highlighted AstraZeneca's commitment to advancing hematology treatments, particularly through acalabrutinib-based combination regimens. The company aims to expand to more therapeutic areas through innovative partnerships with local Chinese companies, ultimately providing clinical benefits to a broader population of cancer patients in China.

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