TRANSTHERA-B (02617) announced the publication of exploratory clinical results for its core product, tienegotinib, both as a monotherapy and in combination with atezolizumab for treating advanced solid tumors, in the journal Nature Communications (Impact Factor: 15.7). Tienegotinib is a kinase-selective multi-kinase inhibitor targeting Fibroblast Growth Factor Receptors 1-3 (FGFR1-3), Janus Kinase 1/2 (JAK1/2), Vascular Endothelial Growth Factor Receptors (VEGFRs), and Aurora Kinase A/B.

The China-based Phase Ib/II clinical trial (Trial ID: NCT05253053) evaluated the efficacy of tienegotinib monotherapy in Group A (53 patients with advanced solid tumors) and its combination with atezolizumab in Group B (31 patients with advanced biliary tract tumors). The objective response rate (ORR) was 16.7% for the monotherapy group and 22.6% for the combination group, demonstrating antitumor activity.

In a prespecified exploratory subgroup analysis, patients with cholangiocarcinoma showed significant efficacy. The ORR reached 30.8% in Group A (n=13) and 25.0% in Group B (n=28). For cholangiocarcinoma patients with FGFR2 fusion mutations who had progressed after prior FGFR inhibitor therapy, tienegotinib monotherapy achieved an ORR of 66.7%. Among 20 cholangiocarcinoma patients previously treated with immune checkpoint inhibitors, the combination regimen yielded an ORR of 20.0% and a disease control rate of 75.0%.

These findings support the further clinical development of tienegotinib both as a monotherapy and in combination with immunotherapy.