Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 426

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 426
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 ​   II      ​   Fully enrolled registration phase 2025 March Data at ASCO 2023   ​   NCT04353375
Fanregratinib + chemotherapies or Tuoyi (PD-1)   ​   Solid tumors                   China       I/II        Ongoing                                                              NCT05173142
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Phase II study of fanregratinib in 2L IHCC with FGFR2 fusion (NCT04353375)
The registration phase of an ongoing China Phase II open-label, single-arm study of fanregratinib in 2L IHCC with FGFR2 fusion started after we consulted with NMPA in 2023. If positive, the data may be used to support a future NDA filing. We dosed the first patient in March 2023 and completed recruitment of 87 patients in March 2025.
Results of an earlier cohort of the same China Phase II open-label, single-arm study (also NCT04353375) were reported at ASCO 2023. IHCC patients with FGFR2 fusion pretreated with at least one line of systemic therapy received either fanregratinib 150mg OD (cohort 1) or 300mg OD 2 weeks on/1 week off (cohort 2, chosen as RP2D). At data cutoff date of September 21, 2022, 25 patients were treated with median follow-up of 12.0 months for cohort 1 (12 evaluable patients) and 4.1 months for cohort 2 (10 evaluable patients). ORR was 50% and DCR was 90% in cohort 2, while DoR was not reached. PFS was 5.7 months in cohort 1 and not mature in cohort 2. Grade ≥3 TRAEs occurred in 23.1% in cohort 2, with no treatment discontinuation. For both cohorts combined, the most common Grade ≥3 TRAEs were decreased neutrophil count (8%), nail toxicity (8%) and hand-foot syndrome (8%).
Phase Ib/II study of fanregratinib in combination with chemotherapies or toripalimab in solid tumors (NCT05173142)
China Phase Ib/II open-label, two-stage study started in 2022 to evaluate the use of fanregratinib in combination with chemotherapy (gemcitabine and cisplatin) or