February 15, 2022, Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that it would conduct a clinical study on the combination therapy of its investigational pan-FGFR inhibitor ABSK091 and tislelizumab, an anti PD-1 antibody developed by BeiGene, for the treatment of urothelial cancer.

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 strong potential for combination with other targeted or immunogenic drugs. Abbisko Therapeutics is currently conducting a Phase II clinical trial of ABSK091 monotherapy in urothelial cancer in China. At  the  same  time,  the  results  of  several  clinical  trials  at  home and abroad have shown that the combination of FGFR inhibitors and anti-PD-1 antibodies has significant effect on urothelial cancer.

According to research reports, the prevalence of urothelial cancer patients in China was about 200,000 in 2020. The FGFR aberration rate in urothelial cancer is approximately 30%. Studies have shown that combination therapies of precision oncology and immuno-oncology drugs have demonstrated improved efficacy and safety profiles due to their different mechanisms of action. With the upcoming study of ABSK091 in combination with  Tislelizumab,  we  hope to fast-track the clinical development of our agent in China and bring this potentially valuable treatment to a large population of cancer patients.

No monetary consideration is involved under the clinical supply agreement with BeiGene.

About ABSK091 

ABSK091, previously known as AZD4547, is a highly potent and selective inhibitor of FGFR subtypes 1, 2 and 3. Prior to the in-licensing of ABSK091 (AZD4547) by Abbisko Therapeutics, AstraZeneca has completed multiple clinical trials for AZD4547, including two Phase I trials and two Phase II trials. Among the clinical trials conducted by AstraZeneca, the BISCAY Phase Ib trial, a study in patients with advanced urothelial cancer who have progressed on prior treatments, achieved 31.3% response rate in the ABSK091 (AZD4547) monotherapy arm. In November 2019, Abbisko Therapeutics entered into an exclusive license agreement with AstraZeneca and obtained the global rights for the development, manufacturing and commercialization of ABSK091 (AZD4547). 

About Tislelizumab

Tislelizumab (BGB-A317), a humanized IgG4 monoclonal antibody against PD-1, was first launched commercially in China in March 2020. It has been approved for six indications in China, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and  for second- or third- line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy. The China NMPA has also granted conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) 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, and for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials. Tislelizumab is currently being developed as monotherapy and combination therapy for a range of solid and hematologic tumors.

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