
China CDE clears Phase 3 Study of Lisafltoclax in Newlly Diagnosed Patients with Higher-Risk Myelodysplastic Syndrome
Natalia Elliot | August 13, 2024 | News story | Clinical Research, Research and Development | Ascentage Pharma, Oncology
The China Centre for Drug Evaluation (CDE) has cleared the registrational phase 3 study of lisaftoclax in combination with azacitadine for the first time in newly diagnosed patients with higher-risk myelodysplastic syndrome (MDS).
A new drug application (NDA) is expected to be filed in China for Lisaftoclax as the first Bcl-2 inhibitor for the treatment of lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
A second NDA is expected to be filed globally in any country which has demonstrated clinical activity and entered pivotal registrational studies for the treatment of patients with CLL.
Dr Yifan Zhai, chief medical officer of Ascentage Pharma, commented: “There is considerable unmet clinical need for patients with MDS. Lisaftoclax, a Bcl-2 inhibitor, has already shown promising clinical benefit and tolerability in early studies in patients with MDS,”
This study (GLORA-4) is to evaluate the efficacy of lisaftoclax in combination with azacitadine in newly diagnosed adult patients with higher-risk MDS. GLORA-4 is a randomised, multicentre and double-blind, phase 3 trial.
“We are very encouraged by this approval for initiation of the registrational phase 3 study in the first-line treatment of patients with higher-risk MDS, as it clears the way for the fourth registrational phase 3 study of lisaftoclax. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will actively press ahead with the clinical trials of lisaftoclax for the benefit of more patients.”
Natalia Elliot
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