HutchMed completes patient enrollment for cancer drug trial

Grafa03-06

HUTCHMED (NASDAQ:HCM) announced today the completion of enrollment in its Phase II clinical trial evaluating fanregratinib (HMPL-453) for patients with advanced intrahepatic cholangiocarcinoma (IHCC) harboring fibroblast growth factor receptor 2 (FGFR2) fusion/rearrangement.

The single-arm, multi-center, open-label study, designed as a registration trial, enrolled 87 patients and aims to assess the efficacy, safety, and pharmacokinetics of fanregratinib.

The primary endpoint of the trial is the objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), and overall survival (OS).

Fanregratinib, a selective FGFR inhibitor, is being investigated as a potential treatment for IHCC, a rare and aggressive form of bile duct cancer.

The trial, identified by NCT04353375 on clinicaltrials.gov, commenced dosing its first patient in March 2023.

HUTCHMED anticipates releasing topline results from the study around the end of 2025.

Positive findings from this trial could pave the way for a New Drug Application (NDA) submission to China’s National Medical Products Administration (NMPA).

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