ESMO Gastrointestinal Cancers Congress 2026 | iPharmaCenter

Fanregratinib Delivers Strong Phase II Signal in FGFR2‑Driven iCCA

HUTCHMED tested its FGFR inhibitor fanregratinib (HMPL‑453) in a registration‑oriented Phase II study run at 53 hospitals across China. The trial followed a single‑arm, open‑label design and enrolled adults with intrahepatic cholangiocarcinoma that was advanced, metastatic or not suitable for surgery, and confirmed to carry FGFR2 fusions or rearrangements.

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All participants had already been through systemic treatment. Every patient had previously received chemotherapy, and close to three‑quarters had also been treated with immunotherapy, reflecting a population with limited remaining options.

Main efficacy signals

Tumour responses were assessed by an independent committee using RECIST criteria, and the study reached its principal goal. Key outcomes included:

• Objective response rate: 42.5 percent

• Disease control rate: 83.9 percent

• Median time to response: about 1.4 months

• Median duration of response: 6.9 months

• Median progression‑free survival: 6.9 months

• Median overall survival: 16.6 months

Taken together, these figures point to meaningful and durable anti‑tumour activity in a biomarker‑selected group of iCCA patients who had already exhausted standard systemic therapies.

Where regulators stand

On the back of these results, China’s National Medical Products Administration has taken forward HUTCHMED’s application for fanregratinib in FGFR2‑altered intrahepatic cholangiocarcinoma and placed it under priority review. The move signals that the agency views this targeted approach as potentially important for a small but high‑risk patient subgroup.