Clinical TrialJun 24, 2026, 08:00 PM
HUTCHMED Fanregratinib Phase II shows 42.5% ORR in ICC; NDA accepted
AI Summary
HUTCHMED announced positive results from its pivotal Phase II registration study of fanregratinib (HMPL-453) for advanced intrahepatic cholangiocarcinoma (ICC) patients with FGFR2-fusions/rearrangements. The study demonstrated a high objective response rate of 42.5% and durable disease control, with a median overall survival of 16.6 months. Supported by these findings, a New Drug Application for fanregratinib has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA).
Key Highlights
- Fanregratinib Phase II study achieved an Independent Review Committee-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%).
- Median duration of response (DoR) was 6.9 months (95% CI: 5.6–8.5).
- Disease control rate (DCR) reached 83.9% (95% CI: 74.5%–90.9%).
- Median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2).
- Median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6).
- New Drug Application (NDA) for fanregratinib accepted for review and granted priority review by China NMPA in December 2025.
- Drug-related adverse events of Grade 3 or greater occurred in 48.3% of patients.
- Treatment discontinuation due to drug-related adverse events was limited to 2.2% of patients.
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