The company stated that in the trial’s registration phase, a total of 87 subjects were enrolled. Credit: Freedomz / Shutterstock.
Hutchmed has concluded enrolment of its multi-centre Phase II trial of fanregratinib (HMPL-453), a treatment for intrahepatic cholangiocarcinoma (IHCC) individuals with fibroblast growth factor receptor 2 (FGFR2) fusion/rearrangement.
The single-arm, open-label registration study aims to assess the therapy’s safety, pharmacokinetics, and efficacy in advanced IHCC subjects who have FGFR2 fusion/rearrangement.
Its primary endpoint is the objective response rate (ORR), and the secondary endpoints are disease control rate (DCR), overall survival (OS), duration of response (DoR), and progression-free survival (PFS).
In the trial’s registration phase, a total of 87 subjects were enrolled. The announcement of the top-line outcomes is anticipated by the end of this year.
Favourable outcomes from the trial could help the company to file a new drug application with the National Medical Products Administration (NMPA) in China.
In March 2023, the therapy’s initial dose was received by the first subject.
Fanregratinib is stated to be a selective and potent inhibitor that targets FGFR 1, 2, and 3. Its complete rights are being retained by the company globally.
According to the company, the signalling of aberrant FGFR has been identified as a key driver of tumour growth, promoting angiogenesis and anti-tumour therapy resistance. Abnormal alterations in the FGFR gene are stated to play a central role in driving tumour cell proliferation in various solid tumour settings.
In April 2023, the company consulted with the NMPA of China and agreed to initiate the registration stage of the Phase II trial for IHCC individuals with FGFR2 fusion.
As a commercial-stage biopharmaceutical company, Hutchmed is focused on developing targeted therapies and immunotherapies for cancer and immunological conditions.
With a focus on in-house discovery, the company marketed its first three medicines in China, with the first also approved in Europe, Japan, and the US.
Email newsletter icon
Sign up for our daily news round-up!
Give your business an edge with our leading industry insights.