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On April 12, Junshi Bio announced that the third indication of "Treprizumab" was officially approved by the NMPA for the treatment of locally advanced or metastatic urothelial carcinoma (UC) that has been previously treated.
At present, teriprizumab has been approved for melanoma and nasopharyngeal carcinoma indications.
The marketing application for this new indication is based on the POLARIS-03 study (NCT03113266), which is an open, single-arm, multi-center, phase II key registration clinical study, which aims to evaluate the failure of standard treatment of teriprizumab Safety and effectiveness in patients with locally advanced or metastatic bladder urothelial cancer.
At the ASCO GU seminar in February 2020, Junshi announced the analysis data of the POLARIS-03 study.
Urothelial carcinoma is one of the main tumors of the urinary system.
In the past, the first-line treatment of advanced urothelial cancer was mainly chemotherapy, but for patients who failed the standard chemotherapy regimen, the second-line treatment options were limited.
Based on the Phase II BGB-A317-204 clinical study in China, tislelizumab was approved in April 2020 for the treatment of locally advanced or metastases that have failed platinum-containing chemotherapy, including neoadjuvant or adjuvant chemotherapy, which has progressed within 12 months Patients with urothelial carcinoma with high expression of PD-L1.
