HUTCHMED (China) Limited (HCM) announced the completion of enrollment in its Phase II registration study evaluating fanregratinib or HMPL-453 for the treatment of intrahepatic cholangiocarcinoma or IHCC patients with FGFR2 fusion/rearrangement.
The open-label, single-arm, multi-center study aims to assess the efficacy, safety, and pharmacokinetics of fanregratinib in advanced IHCC patients.
A total of 87 patients have been enrolled, with the primary endpoint being the objective response rate or ORR. Secondary endpoints include progression-free survival or PFS, disease control rate or DCR, duration of response or DoR, and overall survival or OS.
The first patient received the first dose in March 2023, and HUTCHMED expects to announce topline results from the study around the end of 2025. If favorable, these results could pave the way for a New Drug Application or NDA submission to China's National Medical Products Administration or NMPA.
Fanregratinib is a highly selective inhibitor targeting FGFR1, 2, and 3, which are implicated in tumor growth and resistance to cancer therapies.
IHCC is a type of primary bile duct cancer, and FGFR2 fusion has been found in 10-15 percent of IHCC patients. HUTCHMED retains global rights to fanregratinib.
HCM closed Wednesday's (Mar. 05, 2025) trading at $16.75, up 4.10 percent on the Nasdaq.
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