HUTCHMED's Experimental Drug Shows Durable Responses In Advanced Bile Duct Cancer Trial

HUTCHMED (China) Limited (NASDAQ:HCM) on Thursday said results from its pivotal Phase 2 registration study evaluating fanregratinib (HMPL-453) in patients with intrahepatic cholangiocarcinoma (ICC) will be presented at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress.

ICC is an aggressive cancer that forms in the small bile ducts inside the liver.

The company said the data underpin a New Drug Application for fanregratinib that was accepted for review and granted priority review by China’s National Medical Products Administration (NMPA) in December 2025.

The NDA seeks approval for fanregratinib to treat adult patients with advanced, metastatic, or unresectable ICC harboring fibroblast growth factor receptor (FGFR)2 fusion or rearrangement whose disease progressed following prior systemic therapy.

Phase II Study Meets Primary Endpoint

The single-arm, multicenter, open-label Phase II trial enrolled patients across 53 sites in China to assess the efficacy, safety, and pharmacokinetics of fanregratinib in advanced ICC patients with FGFR2 fusion or rearrangement.

All enrolled patients had previously received at least one line of systemic treatment.

Every participant had undergone chemotherapy, while 72% had also received immunotherapy.

According to the company, the study achieved its primary endpoint, with an independent review committee assessing an objective response rate of 42.5%.

Secondary endpoints also indicated sustained clinical activity. Fanregratinib produced a median time to response of 1.4 months, while the median duration of response reached 6.9 months. The disease control rate was 83.9%.

Median progression-free survival was 6.9 months, and median overall survival was 16.6 months.

Safety Profile Remains Manageable

HUTCHMED said fanregratinib demonstrated a manageable safety profile consistent with selective FGFR inhibitors.

Drug-related adverse events of Grade 3 or higher occurred in 48.3% of patients. The most commonly reported events included elevated liver enzymes and palmar-plantar erythrodysesthesia syndrome.

Treatment discontinuations related to adverse events were reported in 2.2% of patients, and the study recorded no treatment-related deaths.

HCM Stock Price Activity: HUTCHMED (China) shares were up 1.07% at $10.38 at the time of publication on Thursday, according to Benzinga Pro data.

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