#USA #San Diego #Ascentage Pharma #Lisaftoclax #CLL Treatment

Lisaftoclax's Emerging Role in CLL Treatments

Overview

At the 66th Annual Meeting of the American Society of Hematology (ASH 2024), Ascentage Pharma announced groundbreaking clinical data on its investigational Bcl-2 inhibitor, Lisaftoclax (APG-2575). This data presents a significant advancement in the treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), particularly for patients with previous exposure to Venetoclax.

Clinical Insights

The study, primarily led by Dr. Matthew Davids from the Dana-Farber Cancer Institute, focused on various patient cohorts and revealed that Lisaftoclax, either as a monotherapy or in combination with other treatments like Acalabrutinib, showcases a high overall response rate (ORR) of 98%. This remarkable efficacy is particularly relevant for patients previously treated with Venetoclax, highlighting the lack of competing drug interactions (DDIs) or significant safety concerns.

During the clinical trial conducted from March 20, 2020, to June 27, 2024, a total of 176 patients were enrolled. Of these, 154 patients had relapsed or refractory (R/R) CLL/SLL, while 22 patients were treatment-naive (TN). Key results showed a median progression-free survival (PFS) that has yet to be determined but was noted at 12 months at 84% for those who had previously been treated with Venetoclax.

Efficacy and Safety

Ascentage’s ongoing studies reaffirm the strong capability of Lisaftoclax, especially when paired with Acalabrutinib. Remarkably, amongst patients who relapsed post-Venetoclax therapy, a response rate of 86% was achieved, showcasing Lisaftoclax's potential to provide effective treatment options to those with limited alternatives.

Safety assessments yielded favorable results, allowing for a rapid dose escalation from 20 mg to a target of 400, 600, or 800 mg within just a few days. Common adverse events, predominantly infections and cytopenias, were reported without significant escalation into severe toxicity. Importantly, the observed rate of tumor lysis syndrome (TLS) was very low at 1.1%, further underscoring its safety profile.

Regulatory Advances

The discussion on Lisaftoclax also brought to light that a New Drug Application (NDA) has been accepted in China with Priority Review status, with hopes that it will become the second Bcl-2 inhibitor authorized globally. In the U.S., a global registrational Phase III study of Lisaftoclax has already been approved and is currently recruiting participants.

Conclusion

These results showcased at ASH 2024 not only underline the significant therapeutic benefits Lisaftoclax presents in treating CLL, especially for those previously treated with other therapies, but they also highlight Ascentage Pharma's commitment to addressing global unmet medical needs. With ongoing studies and global enrollment in view, Lisaftoclax stands poised as a promising addition to the arsenal against CLL treatment.

Ascentage Pharma (6855.HK) remains at the forefront of innovative biopharmaceutical development, with a strong pipeline dedicated to addressing malignancies and improving patient outcomes globally.