Ascentage Pharma Group International presented the results of a Phase II registrational study of its Bcl‑2 inhibitor lisaftoclax (APG‑2575) at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. The study enrolled 77 patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma who had failed Bruton’s tyrosine kinase inhibitors.
The data showed an objective response rate of 62.5% and a median progression‑free survival of 23.9 months. In high‑risk subgroups—patients with complex karyotype, del(17p)/TP53 mutation, or unmutated IGHV—the response rate remained robust, with 63.6% of those with complex karyotype achieving durable disease control. No tumor‑lysis syndrome events were reported, underscoring the safety profile of lisaftoclax in this heavily pre‑treated population.
These results reinforce lisaftoclax’s clinical differentiation in China, where it became the first Bcl‑2 inhibitor approved in July 2025. The data support the company’s commercial launch strategy and signal progress toward expanding the drug’s indication portfolio, potentially accelerating revenue generation and strengthening Ascentage’s position as a commercial‑stage biopharma in oncology.
The presentation also highlights the drug’s performance relative to the broader Bcl‑2 inhibitor landscape, where venetoclax is the established standard. Lisaftoclax’s efficacy in BTK inhibitor‑refractory patients and its favorable safety profile position it as a compelling alternative, opening opportunities for combination therapies and new indications such as myeloid malignancies.
Overall, the Phase II data presentation at ASH 2025 underscores Ascentage Pharma’s ability to deliver clinically meaningful outcomes in a challenging patient population, bolstering confidence in its pipeline and commercial strategy.
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