HUTCHMED's Sovleplenib Shows Promising Long-Term Efficacy in ITP Phase III Trial
Key Insights
HUTCHMED will present updated data from the ESLIM-01 Phase III trial of sovleplenib in adult patients with primary immune thrombocytopenia (search) (ITP) at the ASH Annual Meeting.
Long-term data from the open-label sub-study of ESLIM-01 demonstrated effective and sustained platelet count increase with sovleplenib in chronic ITP patients in China.
The overall response rate was 81%, with a durable response rate of 51.4% and a long-term durable response rate of 59.8%, and the treatment was well-tolerated.
HUTCHMED (China) Limited is set to present new and updated data from its ESLIM-01 Phase III trial evaluating sovleplenib in adult patients with primary immune thrombocytopenia (search) (ITP) at the American Society of Hematology (ASH) Annual Meeting on December 8, 2024, in San Diego, USA. The data includes long-term safety and efficacy results from a follow-on, open-label sub-study of the extension stage of the ESLIM-01 trial (NCT05029635).
The initial results from the ESLIM-01 trial, reported last August, indicated that sovleplenib met its primary endpoint of durable response rate and all secondary endpoints in adult patients with primary ITP in China.
Long-Term Efficacy and Safety of Sovleplenib
The follow-on sub-study data, with a data cut-off of January 31, 2024, included 179 patients treated with at least one dose of sovleplenib. A significant 55.3% (99/179) of patients remained on treatment in the sub-study, with a median duration of exposure of 56.6 weeks. The results demonstrated that long-term treatment with sovleplenib effectively increased and maintained platelet count in adults with chronic primary ITP in China.
In the overall population, 81% (145/179) of patients achieved an overall response. The durable response rate was 51.4%, and the long-term durable response rate reached 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.
Yu Hu from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, will present these findings at the ASH Annual Meeting in a poster session titled "Long-Term Sovleplenib Treatment of Adults with Primary Immune Thrombocytopenia (search) in China" (#2558) on Sunday, December 8, 2024.
Additional HUTCHMED Presentations at ASH and ESMO Asia
In addition to the sovleplenib data, HUTCHMED will present several updates on investigator-initiated studies of compounds it discovered at both the ASH Annual Meeting and the European Society for Medical Oncology (ESMO) Asia Congress 2024, taking place in Singapore. These presentations will cover studies involving fruquintinib and surufatinib in various cancer settings.
Presentations at the ESMO Asia Congress 2024 include:
- Efficacy and safety of fruquintinib combined with serplulimab as 1st line treatment in advanced non-clear cell renal cell carcinoma (nccRCC) (Abstract #274MO)
- Stereotactic body radiation therapy followed by fruquintinib in combination with immunotherapy as third- and later-line treatment in metastatic colorectal cancer (Abstract #81P)
- Results from FRONT study: A multicenter, randomized, open-label clinical trial of fruquintinib as maintenance therapy after 1L treatment in metastatic colorectal cancer (mCRC) (Abstract #82P)
- Fruquintinib in combination with S-1 for ESCC patients after first-line immunotherapy failure (Abstract #194P)
- Efficacy and safety of concurrent bevacizumab in combination with standard radiotherapy and temozolomide followed by bevacizumab in combination with temozolomide and surufatinib in glioblastoma (Abstract #766P)