Clinical TrialJun 25, 2026, 06:12 AM
HUTCHMED Fanregratinib Phase II Data Shows High Response in ICC
AI Summary
HUTCHMED announced pivotal Phase II registration study results for fanregratinib (HMPL-453) in patients with advanced intrahepatic cholangiocarcinoma (ICC) with FGFR2 fusion/rearrangement. The data, presented at the ESMO Gastrointestinal Cancers Congress 2026, demonstrated a high objective response rate of 42.5% and a manageable safety profile. The New Drug Application for fanregratinib was accepted for review and granted priority review by the China NMPA in December 2025.
Key Highlights
- Pivotal Phase II data for fanregratinib in intrahepatic cholangiocarcinoma (ICC) presented.
- NDA for fanregratinib accepted and granted priority review by China NMPA in December 2025.
- Independent Review Committee-assessed Objective Response Rate (ORR) was 42.5%.
- Median Duration of Response (DoR) was 6.9 months.
- Median Progression-Free Survival (PFS) was 6.9 months.
- Median Overall Survival (OS) was 16.6 months.
- Drug-related adverse events of Grade 3 or greater reported in 48.3% of patients.
- Treatment discontinuation due to drug-related adverse events was limited to 2.2%.
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