On April 8, 2021, Toripalimab injection(recombinant humanized anti-PD-1 monoclonal antibody injection, JS001) is used to treat locally advanced or metastatic bladder urothelium after failure of standard treatment Cancer (UC) indications were officially approved by NMPA. Meta Clinical Technology Co. Ltd., undertook the data management service of this study, and cooperated with Junshi and contributed to the application and approval of this indication.During the entire project implementation process, Meta is responsible for the routine data management, progress report, EDC data cleaning, medical coding, medical audit list programming, SAE consistency verification, external data consistency verification, and multiple rounds database lock, rolling database freezes and locks, host data review meetings, and related data management plans and report development.The data management team of Meta sacrificed holidays and worked overtime to gain more time for statistical analysis while ensuring quality.
During the on-site inspection of the two sites: Renji Hospital affiliated of Shanghai Jiaotong University School of Medicine and Peking University Cancer Hospital , the main data management members Meta were on-site to support the whole process and closely cooperated with the Junshi team. The on-site inspection was successfully.
Attached to the latest research analysis data released by Junshi Bio at the American Society of Clinical Oncology Symposium on Urogenital Tumors (ASCO GU) held in February last year:
A total of 151 patients with locally advanced or metastatic urothelial carcinoma were enrolled in the study. As of the data cut-off date, the independent data committee's evaluation results showed that among the 148 patients who met the evaluation criteria, the overall objective response rate (ORR) of 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 is not yet mature, and the safety data are basically consistent with previous reports of Toripalimab.