{"id":12988,"date":"2023-10-13T13:43:00","date_gmt":"2023-10-13T05:43:00","guid":{"rendered":"https:\/\/flcube.com\/?p=12988"},"modified":"2024-11-16T13:47:40","modified_gmt":"2024-11-16T05:47:40","slug":"ascentage-pharma-initiates-phase-iii-study-for-apg-2575-and-calquence-in-cll-sll","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=12988","title":{"rendered":"Ascentage Pharma Initiates Phase III Study for APG-2575 and Calquence in CLL\/SLL"},"content":{"rendered":"\n

Suzhou-based Ascentage Pharma (HKG: 6855<\/a>) 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.<\/p>\n\n\n\n

Innovative Mechanism of Action for APG-2575<\/strong><\/p>\n\n\n\n

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.<\/p>\n\n\n\n

Calquence: A Key Player in CLL\/SLL Treatment<\/strong><\/p>\n\n\n\n

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.<\/p>\n\n\n\n

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<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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