HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013), a biopharmaceutical company based in China, is preparing to unveil the topline and subgroup results from the Phase III ESLIM-01 study at the European Hematology Association’s (EHA) 2024 annual conference. Additionally, the company will present updated clinical data for its hematological malignancy therapies HMPL-306, HMPL-760, and tazemetostat.
The ESLIM-01 study is a randomized, double-blinded, placebo-controlled Phase III trial that evaluated sovleplenib in adult patients with primary immune thrombocytopenia (ITP) who had previously received at least first-line standard treatment. Among the 188 patients treated with oral sovleplenib or a placebo, sovleplenib demonstrated a rapid and sustained platelet count response. The sustained response rate was 48.4% for sovleplenib versus 0% for the placebo (p<0.0001), with a median response time of 1.1 weeks. The drug’s safety profile was found to be tolerable, with 25.4% of sovleplenib-treated patients experiencing grade 3 or higher treatment-related adverse events (TEAEs), compared to 24.2% in the placebo group. Furthermore, sovleplenib significantly improved patients’ quality of life, particularly in physical function and energy/fatigue (p<0.05).
Sovleplenib is a novel, selective, oral spleen tyrosine kinase (Syk) inhibitor. It is in development for the treatment of hematological malignancies and autoimmune diseases. Syk is a key component in B-cell receptor and Fc receptor (FcR) signaling and is a well-established target for various B-cell lymphoma subtypes and autoimmune disorders, including ITP. In China, sovleplenib has been granted breakthrough therapy designation and priority review status for this indication.- Flcube.com
