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Lisaftoclax is a novel Bcl-2 inhibitor developed by Ascentage Pharma. In November 2024, the New Drug Application (NDA) for lisaftoclax for the treatment of R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) was accepted and granted a Priority Review designation by the Center for Drug Evaluation (CDE) of China’s National Medical Product Administration (NMPA). With this submission, lisaftoclax has become the first China-developed Bcl-2 inhibitor to reach NDA submission in China, and the second Bcl-2 inhibitor with submitted NDAs anywhere in the world. At present, lisaftoclax is being evaluated in four global registrational Phase III studies in major indications such as CLL/SLL, AML, and MDS, including a US Food and Drug Administration (FDA)-cleared multi-country, registrational Phase III trial.
Patricia Kropf, MD
Principal Investigator of the study from Novant Health Cancer Institute
“In this global, multicenter study, lisaftoclax in combination with azacitidine showed promising efficacy and a tolerable safety profile for patients with treatment-naïve or R/R AML and MDS. This data supports the upcoming Phase III study using the combination therapy for this patient population.
Interestingly, lisaftoclax showed the potential to overcome resistance to venetoclax in patients who failed prior treatment with venetoclax, suggesting that it might bring improved treatment outcome. We look forward to releasing more data from this study which will further validate lisaftoclax’s broad therapeutic potential.”
Dr. Yifan Zhai
Chief Medical Officer of Ascentage Pharma
“In previous studies, lisaftoclax combined with azacitidine has already demonstrated significant activity in patients with various myeloid malignancies. In this oral presentation, we report the latest data from a multi-country, multicenter Phase Ib/II study that showed promising antitumor activity and good tolerability of the combination regimen in myeloid malignancies such as AML and MDS.
In particular, lisaftoclax has shown therapeutic potential in venetoclax-refractory patients, making this study the first that reported a Bcl-2 inhibitor overcoming drug resistance to another Bcl-2 inhibitor, thus suggesting that lisaftoclax may bring about a breakthrough to the treatment of myeloid malignancies.
For now, lisaftoclax is being evaluated in multi-country, registrational Phase III studies in AML and MDS. We remain committed to our mission of addressing unmet clinical needs in China and around the world and plan to further accelerate our clinical programs to bring more novel therapeutics to patients as soon as possible.”
