2 December, 2021, Shanghai – Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced dosing of the first patient in the phase II clinical study for ABSK091 (AZD4547), a pan-FGFR inhibitor, in urothelial cancer. 

This clinical study (ABSK091-201, NCT05086666), which completed the enrollment of the first patient, is a phase II, multicenter, single-arm, open-label clinical trial conducted in China, to assess the efficacy of ABSK091 (AZD4547) in patients with locally advanced or metastatic urothelial carcinoma with FGFR2/3 genetic alterations, including mutations and/or fusions. 

"Urothelial cancer is a common malignancy of the urinary system, with 20-30% of patients harboring FGFR aberrations, and currently there is no effective treatment for this group of patients in China," said Professor Dingwei Ye at Fudan University Shanghai Cancer Center, the principal investigator of the study. “There is still a large unmet clinical need. Therefore, I look forward to the clinical trial of this new therapy, which may provide a better treatment option for patients. ” 

"ABSK091 (AZD4547) is one of the most advanced pan-FGFR inhibitors developed worldwide. The enrollment of the first patient in the Phase II clinical trial is another important milestone we have achieved for this program," said Dr. Jing Ji, Chief Medical Officer of Abbisko Therapeutics. “Together with the investigators, we are committed to quickly advance the clinical development of ABSK091 (AZD4547) and strive to provide more and better treatment options for patients.”

About ABSK091 (AZD4547)
 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 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). Abbisko Therapeutics has since completed a Phase I trial in Taiwan and a Phase Ib trial in Mainland China. Further therapeutic areas like gastric cancers are also within the plan. 

About 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%. Surgery or radical cystectomy are the recommended first-line treatment for non-muscle invasive or early-stage urothelial cancer. For advanced or metastatic urothelial cancer, systemic therapies including but not limited to gemcitabine combined with cisplatin/carboplatin, gemcitabine combined with cisplatin/carboplatin and paclitaxel, and immune checkpoint inhibitors are recommended as first-line treatment options. So far there is no FGFR inhibitor approved in China for urothelial cancer.

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