TransThera Sciences Inc, a China-based, clinical-stage biopharmaceutical company, on Thursday reported the publication of clinical results from a US-based Phase 2 trial assessing tinengotinib in patients with Cholangiocarcinoma (CCA) on The Lancet Gastroenterology and Hepatology (Impact Factor: 38.6).

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.

In a multicentre, open-label Phase 2 trial, 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 harbouring other FGFR alterations or FGFR wiled-type tumours.

Results showed that 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.

Dr. Milind Javle of The University of Texas MD Anderson Cancer Center, corresponding author of the publication, said: "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."