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On June 5th, GNTbm announced that its new first-line treatment for Diffuse Large B-cell Lymphoma (DLBCL), selected for an oral presentation at this year’s ASCO, has demonstrated significant statistical differences in both primary and secondary efficacy endpoints.
GNTbm’s drug, Tucidinostat (marketed in Taiwan as Kepida), has already obtained regulatory approval in Taiwan for the treatment of HR+/HER-2- advanced breast cancer. This domestically developed new drug (with its active ingredient, formulation, and clinical trials all conducted in Taiwan) is currently under review for inclusion in Taiwan’s National Health Insurance program.
The latest clinical trial results for Tucidinostat as a first-line treatment for DLBCL were recently presented by Huashang’s partners at ASCO.
According to Taiwan’s cancer registry data, there are approximately 1,750 new DLBCL cases diagnosed annually, with an 8% annual compound growth rate. DLBCL, classified as a highly aggressive non-Hodgkin lymphoma, poses significant treatment challenges.
Huashang noted that research shows about 30% of DLBCL patients exhibit overexpression of MYC/BCL2 proteins, known as "double expression," which is a key reason for the ineffectiveness of the R-CHOP regimen.
To verify whether Tucidinostat can effectively combine with the R-CHOP regimen for treating MYC/BCL2 double-expressing DLBCL patients, Huashang’s partners conducted a multicenter, randomized, double-blind, placebo-controlled pivotal Phase III clinical trial. This trial enrolled 423 MYC/BCL2 double-expressing DLBCL patients, with Event-Free Survival (EFS) at 24 months as the primary efficacy endpoint and Complete Response Rate (CRR) as a critical secondary efficacy endpoint. After six treatment cycles (each cycle lasting three weeks), patients achieving Complete Response (CR) entered a 24-week maintenance phase with either Tucidinostat or a placebo.
ASCO’s oral presentation data indicated that the primary efficacy endpoint, EFS at 24 months (HR 0.68, 95% CI 0.49-0.94, p=0.018), and the key secondary efficacy endpoint, CRR (73% vs. 61.8%, p=0.014), both showed significant improvement and statistical significance in the Tucidinostat group compared to the placebo group.
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