Phase III Trial of Infigratinib Versus Gemcitabine/Cisplatin in FGFR2-Rearranged Cholangiocarcin

17 Mar 20265 min read0 viewsJournal Feed

GIST (Key Takeaways)

Infigratinib, an oral fibroblast growth factor receptor (FGFR) 1-3 inhibitor, showed clinical activity and manageable adverse events in the P2 CBGJ398X2204 study and was conditionally approved for adults with previously treated, unresectable, or metastatic cholangiocarcinoma (CCA) with FGFR2 fusion or other rearrangement.
PROOF 301, reported in this article, is the confirmatory phase III trial of infigratinib versus gemcitabine plus cisplatin as first-line treatment of FGFR2-rearranged CCA.

Clinical Editorial

ESMO Open published a clinical update in Oncology on 17 Mar 2026.

The item focuses on Phase III trial of infigratinib versus gemcitabine/cisplatin in adults with advanced cholangiocarcinoma with FGFR2 gene fusion or rearrangement: results and reflections on early termination of PROOF 301☆.

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