Core Viewpoint - Ascentage Pharma presented promising results from a Phase II study of Lisaftoclax, a Bcl-2 selective inhibitor, for treating relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) at the ASH Annual Meeting, supporting its recent NDA approval in China [1][6][7] Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer [16] - The company has a pipeline that includes inhibitors targeting key apoptotic pathway proteins and next-generation kinase inhibitors [16] Study Results - Lisaftoclax monotherapy showed a 62.5% objective response rate (ORR) in heavily pretreated BTK-refractory R/R CLL/SLL patients, with a median progression-free survival of 23.89 months [6][11] - Among 77 enrolled patients, 42.9% had chromosomal complex karyotype, 39% had del(17p)/TP53 mutation, and 53.2% had unmutated IGHV, indicating a high-risk patient population [3][13] - The study reported no tumor lysis syndrome (TLS) and a manageable safety profile, with frequent grade ≥3 treatment-related adverse events being hematologic toxicities [14][6] Clinical Significance - The results highlight Lisaftoclax's potential as a new treatment option for patients with high-risk CLL/SLL, addressing an urgent clinical need for effective therapies [5][7] - The study's findings suggest that even in ultra-high-risk patients, Lisaftoclax can achieve deep and durable responses, with 21.8% of patients achieving minimal residual disease (MRD) negativity in peripheral blood [11][15] Future Directions - Ascentage Pharma is conducting four global registrational Phase III studies for Lisaftoclax in various indications, including CLL/SLL, acute myeloid leukemia (AML), and myelodysplastic syndrome (MDS) [4][18] - The company aims to accelerate clinical programs to provide safe and effective therapies to patients globally [7]