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TransThera Publishes Clinical Studies of Tinengotinib (TT-00420) against Cholangiocarcinoma on Lancet
TransThera Sciences Inc. ("TransThera") announced the publication of clinical results from a US-based Phase 2 trial evaluating tinengotinib in patients with Cholangiocarcinoma (CCA) on The Lancet Gastroenterology and Hepatology (Impact Factor: 38.6).
About this update from Transthera Sciences (nanjing). Inc.
[{"type":"text","content":"NANJING, China and GAITHERSBURG, Md., Dec. 4, 2025 /PRNewswire/ -- TransThera Sciences Inc. ("TransThera") announced the publication of clinical results from a US-based Phase 2 trial evaluating tinengotinib in patients with Cholangiocarcinoma (CCA) on The Lancet Gastroenterology and Hepatology (Impact Factor: 38.6).","length":332,"tagName":"p"},{"type":"text","content":"Cholangiocarcinoma (CCA) is an aggressive malignancy of the bile ducts, frequently driven by FGFR2 fusions-genomic alterations that are targetable by FGFR inhibitors such as pemigatinib and futibatinib. However, resistance to these agents commonly arises due to secondary FGFR2 mutations.","length":288,"tagName":"p"},{"type":"text","content":"In a multicenter, open-label Phase 2 trial (NCT04919642), patients with FGFR2 fusion-positive CCA who had either primary resistance or developed acquired resistance to prior FGFR inhibitor (FGFRi) therapy were enrolled, along with patients harboring other FGFR alterations or FGFR wiled-type tumors. Tinengotinib demonstrated clinical activity in patients with FGFR2 fusion-positive CCA with acquired FGFRi resistance, as well as in those with other FGFR-altered subtypes.","length":472,"tagName":"p"},{"type":"text","content":"Dr. Milind Javle of The University of Texas MD Anderson Cancer Center, corresponding author of the publication, stated: "We currently have two FDA-approved therapies targeting FGFR2 fusions in CCA. But resistance remains a major clinical challenge. As such, next generation FGFR inhibitors capable of overcoming resistance are urgently needed. Tinengotinib, as a multi-kinase FGFR inhibitor, is designed to inhibit both FGFR and compensatory pathways contributing to resistance. In this phase 2 study, tinengotinib demonstrated durable responses and meaningful clinical benefit. These promising results provide a strong rationale to proceed with a Phase 3 registration study".","length":686,"tagName":"p"},{"type":"text","content":"Dr. Jean Fan, Chief Medical Officer of TransThera, also commented: "We are very pleased that the clinical trial results have gained peer recognition and were published in such a prestigious journal. This study provides important insights into treatment strategies for patients with FGFR-altered, chemotherapy- and FGFR inhibitor–refractory or relapsed CCA, includ...