Hutchmed announces ESLIM-01 trial met primary endpoint

Hutchmed announced that the pivotal Phase III trial ESLIM-01 evaluating the investigational use of sovleplenib met its primary endpoint of durable response rate and all secondary endpoints in adult patients with primary immune thrombocytopenia, or ITP, in China. Hutchmed plans to submit the new drug application, or NDA, around the end of 2023. The National Medical Products Administration of China, or NMPA, granted Breakthrough Therapy designation, or BTD, to sovleplenib for the indication studied in ESLIM-01 in January 2022. The NMPA granted this designation to sovleplenib as a new drug that could treat a serious condition for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies. As such, the sovleplenib NDA may be considered for priority review for its use in ITP. ESLIM-01 is a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in 188 adult patients with primary ITP who have received at least one prior line of standard therapy. Enrollment was completed in December 2022. The trial met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in durable response rate in patients treated with sovleplenib as compared to patients treated with placebo. Secondary endpoints including response rate and safety were also met. Full results will be submitted for presentation at an upcoming scientific conference. Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase for the treatment of hematological malignancies and immune diseases. Syk is a component in Fc receptor, or FcR, and B-cell receptor signaling pathway. ITP is an autoimmune disorder that can lead to increased risk of bleeding. Encouraging proof of concept data was presented at ASH1 2021 and published in The Lancet Haematology in June.