HUTCHMED (00013) announced at the 2026 European Hematology Association Annual Meeting the Phase III data of the ESLIM-02 study for the use of surufatinib in treating warm-type autoimmune hemolytic anemia.

HUTCHMED (00013) announced that the results of the Phase III stage of the ESLIM-02 China study of savolitinib for the treatment of warm antibody hemolytic anemia (wAIHA) patients will be presented at the European Hematology Association (EHA) annual meeting in Stockholm, Sweden on June 11, 2026. Based on the data from the ESLIM-02 study, a new drug application for savolitinib for the treatment of adult wAIHA patients who have previously had poor response to at least one corticosteroid therapy has been accepted by the China National Medical Products Administration in April 2026 and granted priority review. Savolitinib was also designated as a breakthrough therapy by the NMPA in March 2026. The results of the ESLIM-02 study have been selected for publication in the official EHA news. The principal investigator of the ESLIM-02 study, Professor Han Bing from Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences, stated: "In the past few decades, there has been no significant breakthrough in the treatment of warm antibody hemolytic anemia, and patients often fall into a vicious cycle of high-dose steroid treatment and frequent relapses. The data from the ESLIM-02 study are of breakthrough significance, demonstrating that the rapid and lasting control of hemolysis can be achieved by inhibiting the Syk pathway. Particularly encouraging is that all patient subgroups showed strong data regardless of their previous treatment. Savolitinib significantly reduces the need for emergency treatment and blood transfusions in patients, which is an important step towards improving the quality of life for these patients." The ESLIM-02 study is a randomized, double-blind, placebo-controlled Chinese Phase II/III clinical trial (NCT05535933) conducted in adult patients with relapsed or refractory or secondary warm antibody hemolytic anemia who have received at least one standard treatment. The results of the Phase II stage of the study were published in January 2025 in The Lancet Haematology. In the Phase III stage of the study, 90 patients were randomized in a 1:1 ratio to receive once-daily 300 mg savolitinib (n=44) or placebo (n=46) for 24 weeks. The study met its primary endpoint, with a significantly higher sustained response rate in the savolitinib group compared to the placebo group during weeks 5 to 24 (66% vs 15%, p<0.0001). During the 24-week double-blind treatment period, savolitinib showed superior efficacy on multiple key measures; specifically, the overall response rate (defined as hemoglobin (Hb) 100 g/L, and a baseline increase of 20 g/L, without receiving emergency treatment) significantly improved (70% vs 22%, p<0.0001). The proportion of patients in the savolitinib group requiring defined emergency treatment was significantly reduced (16% vs 54%, p=0.0001), and the proportion of patients receiving red blood cell transfusions was also lower (11% vs 43%); the proportion of patients in the savolitinib group with reduced dosages or discontinued use of corticosteroids or other baseline therapies for wAIHA therapy increased (50% vs 15%, p=0.003). The median time to response in the savolitinib group was 3.1 weeks, compared to 6.3 weeks in the placebo group; the median cumulative response duration for all responders was 16.1 weeks and 6.1 weeks, respectively. Additionally, improvements in hemolysis indicators were seen in the savolitinib group compared to the placebo group, indicating reduced hemolysis activity. These efficacy results were consistent in all sensitivity analyses, and subgroup analyses further supported the primary endpoint results. Notably, in patients previously treated with rituximab, the sustained response rate in the savolitinib group was still superior to the placebo group (69% vs 16%, p=0.0022). Savolitinib demonstrated good safety. 43% and 59% of patients in the savolitinib group and placebo group, respectively, experienced Grade 3 or higher treatment-emergent adverse events ("TEAEs"). The most common Grade 3 or higher TEAEs with an incidence of at least 10% were warm antibody hemolytic anemia (18% vs 43%) and upper respiratory tract infections (2% vs 11%). There were no TEAE-related deaths or treatment interruptions reported in the savolitinib group.