On May 17, 2024,
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) announced that key results from the ESLIM-01 Phase III study of
sovleplenib, along with new data about investigational
hematological malignancy therapies
HMPL-306,
HMPL-760, and
tazemetostat, will be showcased at the European Hematology Association (EHA) Hybrid Congress from June 13-16, 2024 in Madrid, Spain and online.
The ESLIM-01 study is a randomized, double-blinded, placebo-controlled Phase III clinical trial in China, focusing on the use of sovleplenib in adult patients with
primary Immune Thrombocytopenia (ITP) who have undergone at least one prior standard therapy. This study, which includes 188 patients randomized to receive either oral sovleplenib or a placebo, revealed that sovleplenib offers a significant and sustained platelet response. The durable response rate for sovleplenib was 48.4%, compared to zero for the placebo group. Most participants in the trial were heavily pretreated, with a median of four previous lines of ITP therapy, and 71.3% had previously received treatment with TPO/TPO-RA1. Post-hoc subgroup analysis confirmed that sovleplenib provided consistent clinical benefits across various ITP patient groups, regardless of their prior treatments or the types and number of previous TPO/TPO-RA therapies they had received.
Additionally, the congress will present findings from the Phase II portion of the ongoing ESLIM-02 Phase II/III study (NCT05535933) of sovleplenib for
warm antibody autoimmune hemolytic anemia (wAIHA). These results demonstrated an encouraging hemoglobin benefit when compared with a placebo. The study noted an overall response rate of 43.8% versus 0% within the initial eight weeks, and a 66.7% response rate over 24 weeks of sovleplenib treatment, which includes patients who switched from the placebo group. Furthermore, the safety profile of sovleplenib was deemed favorable.
HUTCHMED, a biopharmaceutical company listed on Nasdaq, AIM, and HKEX, focuses on discovering, developing, and commercializing targeted therapies and immunotherapies for
cancer and immune diseases. The company employs approximately 5,000 people, with around 1,800 dedicated to oncology and immunology. HUTCHMED has successfully brought several cancer drug candidates from early discovery stages to patients globally, with its first three drugs available in China and one also marketed in the United States.
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