Suzhou-based Ascentage Pharma (HKG: 6855) has announced the approval to commence a global multi-center, randomized, open-label pivotal Phase III clinical trial evaluating the efficacy and safety of APG-2575 combined with Calquence (acalabrutinib) in untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients. Earlier this year, the drug received clearance for a global regulatory Phase III study targeting previously treated CLL/SLL in the United States.
Innovative Mechanism of Action for APG-2575
Lisaftoclax (APG-2575) is a groundbreaking orally administered small-molecule Bcl-2 selective inhibitor, expertly crafted by Ascentage Pharma to combat various malignancies. It operates by selectively blocking the antiapoptotic protein Bcl-2, effectively reinstating the normal apoptosis process in cancer cells, offering a promising therapeutic approach for patients suffering from these malignancies.
Calquence: A Key Player in CLL/SLL Treatment
AstraZeneca acquired Calquence through a $4 billion investment for a 55% stake in Acerta Pharma in 2016. Approved first for mantle cell lymphoma (MCL) in the U.S. in 2017, Calquence expanded its indication to include CLL/SLL in 2019. Recently, it received approval in China for treating MCL and previously treated CLL/SLL in March and September of this year, respectively.
Preliminary results from global Phase II clinical trials have shown that the combination of lisaftoclax and acalabrutinib exhibits remarkable potential, achieving an objective response rate (ORR) of 98% in relapsed/refractory (R/R) CLL/SLL patients and an impressive 100% in newly treated CLL/SLL patients, while maintaining a favorable safety profile akin to monotherapy.-Fineline Info & Tech
