TRANSTHERA-B (02617) announced that the company presented clinical data for its core product, Tienigotinib, as a monotherapy for patients with advanced cholangiocarcinoma (CCA) in a poster session at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). The presentation was titled: A Phase II Study of Tienigotinib in Advanced Cholangiocarcinoma: Analysis of Molecular Response and Resistance Mechanisms. FGFR inhibitors have an established role in treating cholangiocarcinoma with FGFR2 alterations. Tienigotinib, a novel FGFR inhibitor, has demonstrated promising activity in overcoming acquired resistance to prior FGFR inhibitor therapy. This report detailed circulating tumor DNA (ctDNA) biomarker analyses, evaluating Tienigotinib's efficacy in treating CCA patients with FGFR2 fusions and primary resistance to FGFR inhibitors, those with FGFR2 fusions and acquired resistance to FGFR inhibitors, as well as patients with other FGFR mutations or wild-type FGFR. The analysis assessed genomic alterations in patient ctDNA and performed a correlation analysis of efficacy based on ctDNA mutation status and patient subgroups. These results support further in-depth investigation through expanded biomarker sampling in the ongoing Phase III clinical trial.
Comments