Ascentage Pharma Group International (HKEX: 6855) disclosed results from clinical and preclinical studies at the 67th American Society of Hematology (ASH) Annual Meeting, including presentations on three investigational candidates: olverembatinib, lisaftoclax, and APG-5918. One of the lisaftoclax studies was selected for an oral presentation. Innovent Biologics, Inc. is co-commercializing olverembatinib in China.

Lisaftoclax, a Bcl-2 inhibitor approved in China for certain adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), showed a 62.5% objective response rate and a median progression-free survival of 23.89 months in a registrational Phase II study of heavily pretreated patients. In combination with azacitidine, lisaftoclax also demonstrated encouraging preliminary efficacy in patients with newly diagnosed or venetoclax-exposed myeloid malignancies.

Olverembatinib, a China-approved third-generation BCR-ABL inhibitor, was examined in multiple settings. In a global Phase III study for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia, 94.3% of patients achieved complete remission or complete remission with incomplete hematologic recovery by the end of induction, with 66.0% reaching minimal residual disease negativity. Separate registrational trials in tyrosine kinase inhibitor-resistant chronic-phase chronic myeloid leukemia (CML-CP) showed longer event-free survival versus best available therapy. A single-arm study also suggested that olverembatinib may provide a safe and effective second-line therapy, with over 70% of evaluable patients achieving a complete cytogenetic response and 43.6% attaining major molecular response.

Preclinical studies on the embryonic ectoderm development (EED) inhibitor APG-5918 indicated potential to overcome immunomodulatory drug resistance and synergize with cereblon E3 ligase modulators in multiple myeloma. The announcement reiterates that any future approvals for APG-5918 remain subject to regulatory processes.