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Phase III Study of Bcl-2 Inhibitor Lisaftoclax in Combination with BTK Inhibitor Acalabrutinib in Treatment-Na\u00efve Patients with First-Line CLL\/SLL","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Ascentage Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ASH 2022 | Ascentage Pharma to Present Data of Olverembatinib (HQP1351) in Three Oral Reports, Including the First Dataset from the First US Study, at the ASH Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Ascentage Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ascentage Pharma Received Clearance from U.S. FDA to Proceed with Global Registrational Phase III Clinical Trial for Lisaftoclax (APG-2575) in Previously Treated Patients with CLL\/SLL","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"}]
Find Clinical Drug Pipeline Developments & Deals for Lisaftoclax
The two companies will jointly conduct Phase III of the Bcl-2 inhibitor, APG-2575 (lisaftoclax), in combination with AstraZeneca's BTK inhibitor, Calquence (acalabrutinib), in treatment-naive patients with first-line chronic lymphocytic leukemia/small lymphocytic lymphoma.
APG-2575 (lisaftoclax) is a novel, orally administered small molecule Bcl-2 selective inhibitor developed by Ascentage Pharma to treat a range of malignancies by selectively blocking the antiapoptotic protein Bcl-2, thus restoring the normal apoptosis process in cancer cells.
Study demonstrated that Alrizomadlin combined with APG-2575 (lisaftoclax) synergistically inhibited the proliferation of RS4:11-BCL-2 mutant cell lines and the growth of cell-derived xenografts in vivo.
APG-2575 (lisaftoclax), a small-molecule Bcl-2 selective inhibitor treat hematologic malignancies and solid tumors by selectively blocking antiapoptotic protein Bcl-2 and hence restoring normal apoptosis process in cancer cells.
Results from 6 preclinical studies of drug candidates: Bcl-2 inhibitor lisaftoclax (APG-2575) and MDM2-p53 inhibitor alrizomadlin (APG-115), two key products of pipeline - FAK inhibitor APG-2449, EED inhibitor APG-5918 and KRAS Inhibitor APG-1842, will be presented.
Under terms of the agreement, Ascentage Pharma is responsible for conducting the trial and Pfizer is responsible for supplying study drug for Phase Ib/II dose-escalation and expansion study, to evaluate the anticancer activity of lisaftoclax in combination with palbociclib.
This first-in-human global Phase I study assessed the safety, pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and MTD/recommended Phase II dose (RP2D) of lisaftoclax in patients with R/R CLL and other HMs.
Updated data on lisaftoclax have demonstrated favorable preliminary safety and efficacy, including an objective response rate (ORR) of 80% and a favorable tolerability profile, with manageable adverse events (AEs) in patients with R/R CLL/SLL.
APG-2575 is a novel, orally administered small-molecule Bcl-2‒selective inhibitor. APG-2575 is designed to treat hematologic malignancies and solid tumors by selectively blocking antiapoptotic protein Bcl-2 to restore the normal apoptosis process in cancer cells.
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