China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented the latest clinical data on golidocitinib (DZD4205) at the 64th American Society of Hematology (ASH) annual meeting.
Global Multi-Center Phase I/II Study
A global multi-center Phase I/II study for golidocitinib in recurrent refractory peripheral T-cell lymphoma (r/r PTCL) included a total of 51 patients in phase A of the study who received 150 mg or 250 mg of golidocitinib. Among them, 49 r/r PTCL patients completed at least one efficacy evaluation. The results showed that the objective response rate (ORR) was 42.9%, complete response (CR) was 22.4%, and tumor remission was observed in AITL, PTCL-NOS, ALCL ALK, and NKTCL subtypes. The ORR of patients who had previously received HDAC inhibitors was 42.9%. Additionally, one patient previously treated with an EZH2 inhibitor achieved complete remission after receiving golidocitinib. In terms of safety, the most common treatment-emergent adverse events (TEAEs) were neutropenia, thrombocytopenia, and pneumonia. Most TEAEs were recovered or controlled clinically through dosage adjustment.
Translational Study on Effective Treatment
By analyzing pSTAT3 IHC in tumor tissues of 20 patients, it was found that there might be a certain correlation between the efficacy of golidocitinib and the expression level of pSTAT3 in tumor cells. This confirmed that the drug could become a potentially effective treatment method for T cell malignant tumors by inhibiting the JAK/STAT signaling pathway.
DZD4205 Development and Regulatory Status
DZD4205 is an oral, highly selective JAK1 inhibitor being developed to treat blood tumors, solid tumors, and autoimmune diseases. The drug, undergoing pivotal clinical trials in China, the US, South Korea, and Australia, is touted as the world’s first and only highly selective JAK1 inhibitor at the global regulatory clinical stage in the T cell lymphoma treatment area.Fineline Info & Tech
