China’s Ascentage Pharma (HKG: 6855) and UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) have entered into a second clinical collaboration agreement to further study the combination of Ascentage’s Bcl-2 inhibitor lisaftoclax with AZ’s BTK inhibitor acalabrutinib (Calquence). This partnership is specifically aimed at conducting a registrational Phase III trial to evaluate the combo regimen in treatment-naive patients with first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
Previous Collaboration and Positive Results
The two companies initially formed a clinical development partnership in June 2020 to assess the combination of lisaftoclax and Calquence in a global Phase I/II clinical trial. That study yielded excellent results, demonstrating an objective response rate (ORR) of 98% in patients with relapsed/refractory (R/R) CLL/SLL and an ORR of 100% in treatment-naïve CLL/SLL patients. The safety profile was found to be on par with lisaftoclax monotherapy, details of which were released at the 2022 American Society of Hematology (ASH) Annual Meeting.
Advancing to Phase III Trials
Lisaftoclax received US FDA approval to enter the Phase III stage in combination with a BTK inhibitor in August this year, followed by NMPA approval for a Phase III study in combination with Calquence. Ascentage’s molecule is recognized as China’s first and the world’s second Bcl-2 inhibitor to reach the Phase III stage, marking a significant milestone in the development of novel treatments for hematological malignancies.-Fineline Info & Tech
