Live from ASCO 2025 | Ascentage Pharma Presents Clinical Data on Bcl-2 Inhibitor Lisaftoclax in Venetoclax-Refractory Patients in Oral Report

Core Insights - Ascentage Pharma presented promising data on its investigational Bcl-2 inhibitor, lisaftoclax (APG-2575), in combination with azacitidine for treating treatment-naïve or prior venetoclax-exposed myeloid malignancies at the ASCO Annual Meeting [1][2][3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancer treatment, with a pipeline that includes apoptosis-targeted therapies [13][16] - The company has been participating in the ASCO Annual Meeting for eight consecutive years, showcasing its commitment to advancing cancer therapies [2] Study Details - The Phase Ib/II study of lisaftoclax enrolled 103 patients with treatment-naïve or relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) as of April 2025 [3][4] - The study highlighted the antitumor activity and manageable tolerability of lisaftoclax, particularly in patients who were refractory to venetoclax, indicating its potential to overcome drug resistance [5][11] Efficacy Results - Among 28 venetoclax-refractory patients, the overall response rate (ORR) was 31.8%, with 22.8% achieving complete response (CR) or CR with incomplete hematologic recovery (CRi) [14] - In newly diagnosed AML patients, the ORR was 83.3%, with 33.3% achieving CR/CRi [14] - For patients with relapsed/refractory MDS/chronic myelomonocytic leukemia (CMML), the ORR was 50%, with 27.3% achieving CR [14] Safety Profile - Lisaftoclax combined with azacitidine was well tolerated, with common adverse events primarily being hematologic and manageable [10][11] - Non-hematologic toxicity was uncommon, indicating a favorable safety profile for the combination therapy [10] Regulatory Progress - The New Drug Application (NDA) for lisaftoclax for treating relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) was accepted with Priority Review designation in China [4][16] - Lisaftoclax is currently being evaluated in four global registrational Phase III studies for major indications including CLL/SLL, AML, and MDS [4][16]