HUTCHMED (HKG: 00013) has announced that the Phase III results from the ESLIM-02 study of sovleplenib for treating warm antibody autoimmune hemolytic anemia (wAIHA) were presented at the European Hematology Association (EHA) Annual Congress in Stockholm, Sweden, on Thursday, June 11, 2026.
Based on the ESLIM-02 data, a new drug application for sovleplenib for adult wAIHA patients who previously responded inadequately to at least one corticosteroid therapy was accepted for review by China's National Medical Products Administration (NMPA) in April 2026 and granted priority review status.
Sovleplenib was also designated as a Breakthrough Therapy by the NMPA in March 2026. The ESLIM-02 findings were selected for inclusion in the EHA official press program.
Key Investigator Commentary
Professor Han Bing from Peking Union Medical College Hospital, the study's co-principal investigator, stated, "The treatment landscape for wAIHA has seen no substantial breakthroughs in decades, often trapping patients in a cycle of high-dose steroid therapy and frequent relapses. The ESLIM-02 data is groundbreaking, demonstrating that inhibiting the Syk pathway can rapidly and durably control hemolysis. It is particularly encouraging that all patient subgroups showed robust data regardless of prior treatments. Sovleplenib significantly reduces the need for urgent therapy and transfusions, representing a crucial step in improving the quality of life for these patients."
Trial Design and Results
ESLIM-02 is a randomized, double-blind, placebo-controlled Phase II/III clinical trial conducted in China for adult patients with primary or secondary wAIHA who are relapsed or refractory after at least one prior standard therapy. Results from the Phase II portion were published in *The Lancet Haematology* in January 2025.
In the Phase III stage, 90 patients were randomized 1:1 to receive either 300 mg of oral sovleplenib once daily (n=44) or a placebo (n=46) for 24 weeks. The study met its primary endpoint, with a significantly higher durable response rate from weeks 5 to 24 in the sovleplenib group compared to the placebo group (66% vs. 15%, p<0.0001).
Throughout the 24-week double-blind period, sovleplenib demonstrated superior efficacy across multiple key secondary endpoints. Specifically, the overall response rate, defined as hemoglobin (Hb) ≥100 g/L with an increase from baseline of ≥20 g/L without receiving urgent therapy, was significantly higher (70% vs. 22%, p<0.0001).
The proportion of patients using protocol-defined urgent therapy was significantly lower in the sovleplenib group (16% vs. 54%, p=0.0001), as was the proportion receiving red blood cell transfusions (11% vs. 43%).
More patients in the sovleplenib group reduced or discontinued corticosteroids or other baseline concomitant wAIHA therapies (50% vs. 15%, p=0.003).
The median time to response was 3.1 weeks for sovleplenib versus 6.3 weeks for placebo. The median cumulative duration of response for all responders was 16.1 weeks and 6.1 weeks, respectively.
Furthermore, hemolysis markers improved in the sovleplenib group compared to placebo, indicating reduced active hemolysis. These efficacy results were consistent across all sensitivity analyses, with all subgroup analyses further supporting the primary endpoint results. Notably, among patients previously treated with rituximab, the durable response rate remained higher with sovleplenib (69% vs. 16%, p=0.0022).
Safety Profile
Sovleplenib exhibited a favorable safety profile. Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 43% of patients in the sovleplenib group and 59% in the placebo group. The most common Grade 3 or higher TEAEs with an incidence of at least 10% were wAIHA (18% vs. 43%) and upper respiratory tract infection (2% vs. 11%). No TEAE-related deaths or treatment discontinuations were reported in the sovleplenib group.
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