Ascentage Pharma (AAPG) presented new clinical data for Lisaftoclax, at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.
Lisaftoclax is an oral, once-daily small molecule designed to block the anti-apoptotic protein Bcl-2 and restore programmed cell death in cancer cells. It was approved in China this July for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton's tyrosine kinase (BTK) inhibitors.
The drug remains under investigation and has not been approved by the FDA in the U.S.
On December 6, 2025, the company reported results from a pivotal registrational Phase II study of Lisaftoclax monotherapy in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who had failed Bruton's tyrosine kinase (BTK) inhibitors conducted in China.
The study enrolled 77 patients, nearly half of whom had complex karyotype and other high-risk factors such as del(17p)/TP53 mutation and unmutated IGHV.
Lisaftoclax achieved an objective response rate of 62.5% and a median progression- free survival of 23.9 months, with no cases of tumor lysis syndrome observed.
The therapy also demonstrated deep responses, with 21.8% of patients achieving minimal residual disease negativity in peripheral blood and 54.5% in bone marrow. Safety was manageable, with hematologic toxicities such as neutropenia and anemia being the most common adverse events, and no treatment-related deaths reported.
These results supported the drug's approval in China earlier in 2025.
On December 7, 2025, Ascentage presented encouraging data from a Phase Ib/II study of Lisaftoclax in combination with azacitidine (AZA) in patients with newly diagnosed or prior venetoclax-exposed myeloid malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndromes.
The study enrolled 103 patients across multiple cohorts.
Early clinical data show that Lisaftoclax is capable of overcoming venetoclax resistance in myeloid malignancies with a 31.8% overall response rate (ORR) in the subgroup of patients with relapsed/refractory acute myeloid leukemia (AML)/mixed phenotypic acute leukemia (MPAL). An ORR of 80% was achieved in newly diagnosed high-risk myelodysplastic syndrome (MDS)/chronic myelomonocytic leukemia (CMML).
Lisaftoclax also demonstrated strong safety profile with no dose-limiting toxicities across all patient cohorts in the study.
AAPG closed Friday's trading session at $32.88, up 7.10%. Since beginning trading in January 2025, the shares have ranged between a low of $16.50 and a high of $48.45.
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