TRANSTHERA-B (02617) Announces Exploratory Phase 2 Clinical Results of Core Product Tinengotinib for Cholangiocarcinoma

Stock News2025-12-17

TRANSTHERA-B (02617) announced that the exploratory Phase 2 clinical results of its core product, tinengotinib, for cholangiocarcinoma conducted in the U.S. were recently published in *The Lancet Gastroenterology & Hepatology* (impact factor: 38.6). Cholangiocarcinoma is a highly aggressive biliary tract cancer often driven by FGFR2 fusions, which can be targeted by inhibitors such as pemigatinib and futibatinib. However, resistance frequently develops due to acquired FGFR2 mutations.

In this Phase 2, open-label, multicenter study (NCT04919642), eligible cholangiocarcinoma patients included those with FGFR2 fusions exhibiting primary or acquired resistance to FGFR inhibitors, those with other FGFR genetic alterations, and FGFR wild-type patients. Tinengotinib demonstrated the ability to overcome acquired resistance to FGFR inhibitors in FGFR2 fusion-positive cholangiocarcinoma patients and showed antitumor activity in patients with other FGFR genetic alterations.

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