TRANSTHERA-B (02617) has announced the presentation of its latest research findings for its core product, tinengotinib, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The data, presented in a poster session, details the monotherapy treatment of Chinese patients with advanced cholangiocarcinoma who have previously received FGFR inhibitor therapy. While FGFR inhibitors have a clear role in treating chemotherapy-refractory cholangiocarcinoma with FGFR2 alterations, treatment options for patients whose disease progresses after both chemotherapy and FGFR inhibitor therapy remain very limited. Tinengotinib, a novel multi-target inhibitor, has demonstrated the ability to successfully overcome acquired resistance developed from prior FGFR inhibitor treatment. The ASCO presentation disclosed efficacy and safety data for tinengotinib in cholangiocarcinoma patients with FGFR2 alterations whose disease progressed after receiving at least one prior FGFR inhibitor. These results are from an open-label, multicenter Phase II study conducted in China. As of December 27, 2025, a total of 50 patients with advanced cholangiocarcinoma were enrolled and received tinengotinib monotherapy. The median follow-up time was 12 months. All patients had previously received at least one line of chemotherapy and one FGFR inhibitor. Among them, 40% had received ≥3 lines of prior systemic anti-tumor therapy, 66% had received prior immunotherapy, and 46% had received other targeted therapies besides FGFR inhibitors. Tinengotinib demonstrated durable clinical anti-tumor activity and a manageable safety profile in these patients with advanced cholangiocarcinoma harboring FGFR2 fusions/rearrangements who progressed after prior chemotherapy and FGFR inhibitor therapy. According to Blinded Independent Central Review assessment, the objective response rate was 28.0%, with 14 patients achieving a confirmed partial response. The median duration of response was 8.5 months. The disease control rate was 82.0%. The median progression-free survival was 6.1 months. The median overall survival was 20.7 months, with an 18-month survival rate of 51.8%. A global Phase III pivotal study is currently underway to further evaluate the efficacy and safety of tinengotinib in cholangiocarcinoma patients with FGFR2 alterations who have progressed after prior chemotherapy and FGFR inhibitor therapy. Concurrently, a domestic Phase III confirmatory study is ongoing in China to evaluate the efficacy and safety of tinengotinib versus chemotherapy in patients with inoperable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions/rearrangements or mutations, whose disease has recurred or progressed after first-line systemic therapy.
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