Tislelizumab, a novel PD-1 monoclonal antibody in urothelial cancer: a real-world study

Objective: Tislelizumab, a monoclonal antibody against programed death protein -1 (PD -1), has shown encouraging antitumor activity in urothelial cancer. This study was designed to assess the efficacy and safety of tislelizumab in urotelial cancer in a real -world setting. Methods: The study was a real -world retrospective study undertaken at Liaoning Cancer Hospital & Institute, China. Eligible patients were >= 18 years. Patients received 200 -mg tislelizumab monotherapy intravenously every 3 weeks until the disease progressed to intolerable toxicity. Outcomes included an objective response rate (ORR), disease control rate (DCR), progressionfree survival (PFS), overall survival (OS) and safety. Results: Between March 2020 and December 2022, 33 patients were enrolled. The median follow-up was 10.17 (IQR 5.73-12.47) months. Of all 33 patients, ORR and DCR were 30.30% (95% CI 15.6-48.7%) and 42.42% (95% CI 25.48-60.78%), respectively. The median PFS was 5.73 (95% CI 3.27-13.00) months, with a 12 -month PFS rate of 31.90% (95% CI 19.20-53.00%). The median OS was 17.7 (95% CI 12.80 -not reach) months, with a 12 -month OS rate of 67.50% (95% CI 52.70-86.40%). Eleven (33.33%) and 8 (24.24%) experienced >= grade 3 treatment -related adverse events (TRAEs) and immune -related Aes, respectively. No treatment -related deaths occurred. Conclusion: The excellent efficacy and controllable safety of tislelizumab in locally advanced or metastatic urothelial cancer suggest that it may be a promising therapeutic option for this population. (c) 2023 Published by Elsevier Espa & ntilde;a, S.L.U. on behalf of AEU.