China-based pharmaceutical company Ascentage Pharma has received approval for a Phase III clinical trial of lisaftoclax (APG-2575) to treat newly diagnosed higher-risk myelodysplastic syndrome (MDS) patients.
The Chinese National Medical Products Administration’s Center for Drug Evaluation (CDE) gave clearance for the GLORA-4 trial, which will be the fourth registrational Phase III study for lisaftoclax.
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The multicentre, double-blind trial aims to assess the efficacy of lisaftoclax in combination with azacitidine in adults with MDS.
Lisaftoclax is an orally administered Bcl-2 selective inhibitor that restores the normal apoptosis process in cancer cells by selectively hindering the antiapoptotic protein Bcl-2.
It is expected to be the first Bcl-2 inhibitor to have a new drug application filed for chronic lymphocytic lymphoma (CLL) or small lymphocytic lymphoma (SLL) in China and the second worldwide to enter registrational studies after demonstrating clinical activity in CLL treatment.
According to clinical results released last year, lisaftoclax showed promising clinical benefits and tolerability in patients with higher-risk MDS.
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By GlobalDataMDS is a heterogeneous myeloid clonal disease originating from haematopoietic stem cells.
The condition is characterised by the abnormal growth of myeloid cells and can cause haematopoietic failure, refractory cytopaenia and, in high-risk patients, progression to acute myeloid leukaemia.
Ascentage Pharma chief medical officer Dr Yifan Zhai said: “We are very encouraged by this approval for initiation of the registrational Phase III study in the first-line treatment of patients with higher-risk MDS, as it clears the way for the fourth registrational Phase III 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.”
Last year, Ascentage Pharma obtained clearance from the US Food and Drug Administration for a Phase III study of lisaftoclax in patients with CLL/SLL who had previously received a Bruton’s tyrosine kinase inhibitor.
