China-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a regulatory Phase III clinical study for its novel Bcl-2 inhibitor, lisaftoclax (APG-2575). The study will evaluate the efficacy of lisaftoclax in combination with a Bruton’s tyrosine kinase (BTK) inhibitor for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously been treated with BTK inhibitors.
Lisaftoclax (APG-2575): A Selective Bcl-2 Inhibitor
Lisaftoclax (APG-2575) is a novel, orally administered small-molecule Bcl-2 selective inhibitor developed by Ascentage Pharma. The drug targets a range of malignancies by selectively blocking the antiapoptotic protein Bcl-2, thereby restoring the normal apoptosis process in cancer cells. Initial results from a global Phase II study have shown promising objective response rates (ORRs) when lisaftoclax (APG-2575) is combined with the next-generation BTK inhibitor acalabrutinib in patients with CLL/SLL. The study reported an ORR of 100% in treatment-naïve patients and 98% in relapsed/refractory patients.
Patient-Friendly Dosing and Orphan Drug Designations
The study of lisaftoclax (APG-2575) was initiated with a daily dose ramp-up schedule that is patient-friendly and allows for a quick reach of the target dose. The drug has previously obtained orphan drug designations (ODDs) in the US for use in CLL, acute myeloid leukemia (AML), follicular lymphoma (FL), multiple myeloma (MM), and other conditions, highlighting its potential as a treatment for rare diseases.-Fineline Info & Tech
