China-based Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the enrollment of the first patient in a Phase II clinical study for its investigational pan-FGFR inhibitor ABSK091, in combination with BeiGene Ltd’s anti-PD-1 antibody tislelizumab, for the treatment of urothelial carcinoma (UC). This marks the first clinical combination trial of a pan-FGFR inhibitor and immune-oncology therapy in China.
ABSK091 Profile
ABSK091 is a highly potent and selective inhibitor of FGFR subtypes 1, 2, and 3. The drug was licensed from UK-based AstraZeneca in November 2019 with global rights. Studies of multiple FGFR gene-altered tumor models have shown that FGFR inhibitors have good efficacy in vivo and hold potential for combination with other targeted or immunogenic drugs. Results from multiple clinical trials both domestically and internationally have demonstrated that the combination of FGFR inhibitors with anti-PD-1 antibodies has significant potential in the treatment of urothelial carcinoma.
Tislelizumab Profile
Tislelizumab (BGB-A317), a humanized IgG4 monoclonal antibody anti-PD-1, was first commercially launched in China in March 2020. It has been approved for nine indications in China, including non-small cell lung cancer, Hodgkin’s lymphoma, UC, hepatocellular carcinoma, esophageal squamous cell carcinoma, and more. Two additional indications are currently under review in the country.
Future Development
The Phase II clinical study of ABSK091 in combination with tislelizumab underscores Abbisko’s commitment to advancing innovative therapies for urothelial carcinoma. This strategic collaboration aims to explore the potential synergistic effects of combining a pan-FGFR inhibitor with an anti-PD-1 antibody, potentially improving treatment outcomes for patients with this challenging disease.-Fineline Info & Tech
