Toripalimab approved in China to treat urothelial cancer

Tuoyi (toripalimab) injection is the first domestically produced PD-1 monoclonal antibody in China.

In December 2018, toripalimab was approved in China for the treatment of unresectable or metastatic melanoma that has failed previous systemic therapy.
In February 2021, toripalimab was approved for the treatment of recurrent/metastatic nasopharyngeal carcinoma (NPC) that has failed second-line or above systemic therapy.
On April 8, 2021, the official website of the National Administration of China showed that Junshi Biotech’s toripalimab injection, a new drug for the treatment of previously treated locally advanced or metastatic urothelial carcinoma (UC), has been approved. NMPA approved.

Junshi Biologics submitted a marketing application to the NMPA based on the results of an open-label, single-arm, multi-center, phase II pivotal registration clinical study code-named POLARIS-03 (NCT03113266). The study was designed to evaluate the safety and efficacy of toripalimab in patients with locally advanced or metastatic bladder urothelial cancer after failure of standard therapies.

At the American Society of Clinical Oncology Genitourinary Tumors Symposium (ASCO GU) held in February last year, Junshi announced the analysis data of the POLARIS-03 study. A total of 151 patients with locally advanced or metastatic urothelial cancer were enrolled in the study. As of the data cutoff date, the independent data committee’s evaluation results showed that among the 148 patients who met the evaluation conditions, the overall objective response rate (ORR) in the toripalimab group was 25.7%, and the disease control rate (DCR) was 45.9%. The ORR of PD-L1 positive patients (46 cases, 31.1%) reached 41.3%, OS data are not yet mature, and safety data are basically consistent with previous reports of toripalimab.
Urothelial carcinoma (UC) is the most common urinary tract cancer worldwide. Surgery is the main treatment in the early stage. For patients with inoperable locally advanced or metastatic urothelial carcinoma, platinum-based chemotherapy is the standard first-line treatment. As the sensitivity of chemotherapy decreases, it will lead to tumor recurrence and disease progression. .