According to the announcement from Zhitong Finance APP, Chipscreen (688321.SH) stated that the key Phase III clinical trial (DEB study) of its independently developed chidamide for first-line treatment of diffuse large B-cell lymphoma (DLBCL) has recently obtained the final results of the top-line analysis data, showing that the event-free survival (EFS) of the trial group is significantly better than that of the control group, achieving the primary endpoint of the study.

Chidamide acts on epigenetic-related target histone deacetylases (HDAC) of Class I subtypes 1, 2, 3 and Class IIb subtype 10. Histone deacetylases (HDAC) are a class of proteases that play an important role in the structural modification of chromosomes and the regulation of gene expression. As an HDAC inhibitor, chidamide exerts its effects by inhibiting the biological activity of HDAC, resulting in changes in gene expression related to multiple signaling pathways involved in tumorigenesis (i.e., epigenetic changes). Specifically, the general mechanisms of action of chidamide mainly include: ① directly inhibiting the tumor cell cycle and inducing apoptosis; ② inducing and activating natural killer (NK) cells and antigen-specific cytotoxic T lymphocytes (CTL) mediated tumor killing effects; ③ inhibiting the phenotypic transformation of tumor cells and the pro-drug resistance/pro-metastasis activity of the microenvironment.

The announcement indicates that chidamide combined with R-CHOP (CR-CHOP) is the world's first first-line DLBCL treatment regimen that significantly outperforms R-CHOP in terms of complete response (CR) rate in Phase III clinical trials. In this top-line analysis, the event-free survival (EFS) of the trial group showed a statistically significant difference compared to the control group, further validating that the chidamide combination regimen can provide significant and sustainable efficacy for newly diagnosed MYC and BCL2 double-expressing DLBCL patients, with good safety