Investing.com -- HUTCHMED (NASDAQ:HCM) shares rose 2.4% in premarket trading Friday following the presentation of positive Phase III data for sovleplenib in warm antibody autoimmune hemolytic anemia at the European Hematology Association Congress.
The ESLIM-02 study met its primary endpoint, with sovleplenib demonstrating a 66% durable response rate during weeks 5-24 compared to 15% for placebo. The trial evaluated 90 patients in China with warm antibody autoimmune hemolytic anemia who had relapsed or were refractory to at least one prior standard treatment.
The data were presented Thursday at the EHA Congress in Stockholm, Sweden. The presentation was selected for the official EHA Press Program.
In the randomized, double-blind study, sovleplenib showed a 70% overall response rate versus 22% for placebo. The use of rescue therapy was reduced to 16% with sovleplenib compared to 54% with placebo. Fewer patients required red blood cell transfusion with sovleplenib at 11% versus 43% for placebo.
Median time to response was 3.1 weeks for sovleplenib versus 6.3 weeks for placebo. The median cumulative duration of response among overall responders was 16.1 weeks versus 6.1 weeks, respectively.
A New Drug Application for sovleplenib for the treatment of adult patients with warm antibody autoimmune hemolytic anemia who have had an insufficient response to at least one previous glucocorticoid treatment was accepted for review and granted priority review by the China National Medical Products Administration in April. The NMPA granted Breakthrough Therapy Designation to sovleplenib for the treatment of warm antibody autoimmune hemolytic anemia in March.
Grade 3 or higher treatment-emergent adverse events were reported in 43% of patients in the sovleplenib arm and 59% in the placebo arm. No treatment-related deaths or treatment discontinuations were reported in the sovleplenib group.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
The fastest way to find out is with our Fair Value calculator. We use a mix of 17 proven industry valuation models for maximum accuracy. Get the bottom line for HCM plus thousands of other stocks and find your next hidden gem with massive upside.