Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 428

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 428
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                  NCT #      
Ranosidenib   ​   RAPHAEL: r/r mIDH1/2 AML                         ​   China    ​   III     ​   Ongoing since May 2024   ​   NCT06387069
Ranosidenib   ​   r/r mIDH1/2 myeloid hematological malignancies       China        I           Data at EHA 2024             NCT04272957
Ranosidenib   ​   r/r mIDH1/2 AML                                  ​   Global   ​   I       ​   Data at EHA 2024         ​   NCT04764474
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RAPHAEL: Phase III study of ranosidenib in r/r mIDH1/2 AML (NCT06387069)
RAPHAEL is a China Phase III randomized, open-label, active-controlled, registrational study of ranosidenib in r/r AML harboring ІDH1 and/or ІDH2 mutations. Patients will either receive ranosidenib 250 mg OD during first 28-day cycle and then 150 mg OD starting from second cycle, or salvage chemotherapy such as MEC (etoposide, cytarabine, mitoxantrone) or FLAG ± Ida (G-CSF, fludarabine, cytarabine, idarubicin) or cytarabine or azacitidine. The primary endpoint is OS, with secondary endpoints including CR rate, CR+CRh rate, CR+Cri+CRh rate, EFS, DoR, TTR, safety and QoL. The study dosed the first patient on May 11, 2024 and targets recruitment of about 320 patients.
Phase I study of ranosidenib in r/r mIDH1/2 myeloid hematological malignancies (NCT04272957)
China Phase I open-label, two-phase study of ranosidenib in r/r myeloid hematological malignancies (AML, MDS, CMML, MPN) harboring IDH1 and/or IDH2 mutations started in July 2021. Results of dose escalation phase was presented at EHA 2023. At data cut-off date of 2023 April 20, 51 patients were enrolled with median follow-up of 7.4 months. ORR was 33.3% and CR+Cri+CR