Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 162

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 162
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 at 0 - 24 weeks with sovleplenib, compared to 14.5% and 16.1% with placebo (p<0.0001). The median time to response was 8 days with sovleplenib compared to 30 days with placebo. Patients were heavily pretreated with a median of four prior lines of ITP therapy.

Consistent clinical benefits were seen regardless of prior lines of ITP therapies, TPO/TPO-RA treatment types and number of prior regimens. In patients who received four or more prior lines of therapy, the durable response rate was 47.7% with sovleplenib compared to 0% with placebo. 74.6% of patients in the sovleplenib group had received prior treatment with TPO/TPO-RA, and this subgroup demonstrated a significantly higher durable response rate of 46.8% with sovleplenib compared to zero with placebo. The safety profile was consistent with previously reported studies. Grade≥3 TEAEs were reported in 25.4% of patients with sovleplenib and 24.2% with placebo. Sovleplenib also significantly improved quality of life in physical functioning and energy/fatigue (p<0.05).

Table of Contents

A follow-on, open-label sub-study of the extension stage of ESLIM-01 Phase III demonstrated long-term benefits in increasing and maintaining platelet count. The data was presented at ASH 2024. In the overall population, the overall response was achieved by 81% (145/179) of the patients, with a durable response rate of 51.4% and long-term durable response rate of 59.8%. The median cumulative duration of platelet count≥50×10⁹/L was 38.9 weeks. The long-term treatment was well tolerated, with a safety profile consistent with previous studies and no new safety signals were identified.

ESLIM-01 is supported by the results of a randomized, double-blind and placebo-controlled Phase Ib study in ITP presented at ASH 2021. As of data cut-off date of September 30, 2021, a total of 34 patients were randomized to receive sovleplenib and 11 patients to placebo. Among 16 patients who were randomized to receive the RP2D of 300mg OD, 68.8% experienced response as defined by at least one incident of platelet count