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Belumosudil in Japanese patients with cGvHD: Results from a phase III trial
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Results from a phase III trial of belumosudil as a second or subsequent line of therapy in Japanese patients aged ≥12 years with steroid-dependent/resistant chronic graft-versus-host disease (cGvHD) were presented during the European Hematology Association (EHA) 2024 Hybrid Congress by Onishi.1 This analysis evaluated the safety and efficacy of belumosudil at 48 weeks after the last patient enrolment.1 |
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The best overall response rates at 24 weeks (primary efficacy endpoint) and 48 weeks after last patient enrolment were both 85.7%. |
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The median duration of response was 68.1 weeks, and the median failure-free survival and overall survival were not reached. |
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No new safety concerns were observed, and there were no drug-related discontinuations or deaths. |
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The high response rates and tolerable safety profile demonstrated in this trial support the use of belumosudil as a second or subsequent line of therapy in the treatment of Japanese patients aged ≥12 years with steroid-dependent/resistant cGvHD. |
- Onishi Y. Phase 3 Japanese study of belumosudil, a selective ROCK2 inhibitor, as second or subsequent LOT for steroid-dependent/resistant chronic GvHD: Analysis at 48 weeks after the last patient enrolment. Abstract #S262. Presented at: European Hematology Association 2024 Hybrid Congress; Jun 13–16, 2024; Madrid, ES.
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