TRANSTHERA-B (02617): In 2026, the American Society of Clinical Oncology (ASCO) will release key phase II clinical data on the use of Tenofovir alafenamide as monotherapy for advanced bile duct cancer.

TRANSTHERA-B (02617) announced that the company presented the latest research results of its core product ivosidenib as a single-agent treatment for Chinese patients with advanced cholangiocarcinoma previously treated with FGFR inhibitors in a poster format at the 2026 American Society of Clinical Oncology (ASCO) meeting in Chicago. FGFR inhibitors have a clear role in the treatment of chemotherapy-resistant cholangiocarcinoma with FGFR2 mutations. However, treatment options are very limited for patients with advanced cholangiocarcinoma who have failed chemotherapy and FGFR inhibitor therapy. Ivosidenib, as a new multi-target inhibitor, has been shown to successfully overcome acquired resistance caused by previous FGFR inhibitor treatment. At the ASCO meeting, efficacy and safety data of ivosidenib in patients with cholangiocarcinoma carrying FGFR2 mutations who had disease progression after previous FGFR inhibitor treatment were disclosed. These results come from an open-label, multicenter Phase II study (FIRST-08) conducted in China. As of December 27, 2025, a total of 50 patients with advanced cholangiocarcinoma were enrolled and received ivosidenib monotherapy (10mg once daily) treatment. The median follow-up time was 12 months. All patients had previously received at least first-line chemotherapy and one FGFR inhibitor therapy. Among them, 40% of patients had received 3 lines of systemic anti-tumor therapy, 66% had received immunotherapy, and 46% had received other targeted therapies in addition to FGFR inhibitors. Ivosidenib demonstrated durable clinical anti-tumor activity and manageable safety in patients with advanced cholangiocarcinoma carrying FGFR2 fusion/rearrangement who had disease progression after previous chemotherapy and FGFR inhibitor treatment. According to blinded independent central review (BICR) assessment, the objective response rate (ORR) was 28.0%, with 14 patients achieving confirmed partial response; the median duration of response (DoR) was 8.5 months (range: 5.6 to 12.5 months). The disease control rate (DCR) was 82.0%. The median progression-free survival (PFS) was 6.1 months (range: 4.4 to 8.3 months). The median overall survival (OS) was 20.7 months (range: 11.8 to -), with an 18-month survival rate of 51.8%. Currently, a pivotal Phase III study is ongoing globally to further evaluate the efficacy and safety of ivosidenib in patients with cholangiocarcinoma carrying FGFR2 mutations who have disease progression after previous chemotherapy and FGFR inhibitor treatment. (NCT05948475) Simultaneously, a Phase III confirmatory study is being conducted domestically to evaluate the efficacy and safety of ivosidenib compared to chemotherapy for patients with unresectable advanced or metastatic intrahepatic cholangiocarcinoma who have relapsed or progressed after first-line systemic treatment and carry FGFR2 fusions/rearrangements or mutations. (CTR20255200)