Shots:
- HUTCHMED has reported the P-III data (n=90) from P-II/III (ESLIM-02) assessing sovleplenib in in adult patients with primary or secondary wAIHA who had relapsed or were refractory to prior ≥1L of standard treatment; NDA accepted under NMPA priority review in Apr 2026
- Trial met its 1EP of improved durable response rates (66% vs 15%), & showed improved ORR (70% vs 22%), reduced rescue therapy use (16% vs 54%) & RBC transfusions (11% vs 43%), while enabling greater glucocorticoid tapering/discontinuation (50% vs 15%)
- Trial showed a faster median time to response (3.1 vs 6.3wks), median cumulative response duration (16.1 vs 6.1wks.), & improved hemolytic markers, with efficacy remaining consistent across sensitivity & subgroup analyses, incl. in prior rituximab-treated pts where durable response rates reached 69% vs 16%
Ref: Globenewswire | Image: HUTCHMED | Press Release
Related News: HUTCHMED Reports NMPA’s NDA Acceptance under Priority Review for Sovleplenib to Treat wAIHA
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