4 November 2022, Shanghai – Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that it has completed the first patient enrollment in the Phase II clinical trial for investigational pan-FGFR inhibitor ABSK091 in combination with anti-PD-1 antibody tislelizumab developed by BeiGene, Ltd. (“BeiGene”) in urothelial carcinoma. This is the first clinical combination trial of a pan-FGFR inhibitor and immune-oncology therapy in China. 

In June 2022, Abbisko Therapeutics obtained clinical trial approval from the National Medical Products Administration of the People’s Republic of China (“NMPA”) to conduct Phase II clinical trial of ABSK091 in combination with tislelizumab in urothelial carcinoma.

ABSK091 is a highly potent and selective inhibitor of FGFR subtypes 1, 2 and 3. Studies of multiple FGFR gene altered tumor models have shown that FGFR has good efficacy in vivo and has potential for combination with other targeted or immunogenic drugs. Results of multiple clinical trials at home and abroad have shown that the combination of FGFR inhibitors with anti-PD-1 antibodies has enormous potential in the treatment of urothelial carcinoma.

Further, ABSK091 has been granted the orphan drug designation by the Food and Drug Administration of the U.S. for the treatment of gastric cancer in March 2022.

About Tislelizumab

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 conditional approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Tislelizumab is currently being developed as monotherapy and combination therapy for a range of solid and hematologic tumors indications.

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