Mp16-09 Truce04: A Phase Ii Clinical Trial of Rc48 for High-Risk Non-Muscle-Invasive Bladder Cancer (Hr-Nmibc) (Nct05495724)

You have accessJournal of UrologyBladder Cancer: Non-invasive I (MP16)1 May 2024MP16-09 TRUCE04: A PHASE II CLINICAL TRIAL OF RC48 FOR HIGH-RISK NON-MUSCLE-INVASIVE BLADDER CANCER (HR-NMIBC) (NCT05495724) Hailong Hu, Shizheng Guo, Shiwang Huang, Kaipeng Jia, Peng Li, Chong Shen, Zhe Zhang, and Yuanjie Niu Hailong HuHailong Hu , Shizheng GuoShizheng Guo , Shiwang HuangShiwang Huang , Kaipeng JiaKaipeng Jia , Peng LiPeng Li , Chong ShenChong Shen , Zhe ZhangZhe Zhang , and Yuanjie NiuYuanjie Niu View All Author Informationhttps://doi.org/10.1097/01.JU.0001008640.01272.9d.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: RC48 is a novel antibody drug conjugate that targets the Her2 protein and has shown promising efficacy in advanced urothelial cancer. However, its efficacy and safety in early-stage urothelial carcinoma are yet to be fully explored. To address this, we conducted a phase II clinical trial to evaluate the value of RC48 in high-risk non-muscle-invasive bladder cancer (HR-NMIBC). METHODS: In this prospective study, 24 patients with Her2-overexpressing (IHC 2+ or 3+) HR-NMIBC who were unable to undergo complete tumor resection or tolerate surgery were enrolled. The pts received either RC48 120 mg monotherapy or RC48 120 mg combined with tislelizumab 200 mg intravenously, once every three weeks, until disease progression, unacceptable toxicity, or study termination. The effectiveness of RC48 was assessed through cystoscopy, random biopsy, urine cytology, and radiological imaging. Complete response (CR) was defined as all assessment results being negative, indicating the absence of any disease. Stable disease (SD) was defined as having at least one positive assessment result, along with a maximum tumor size increase of no more than 20%, while excluding any evidence of muscle-invasive bladder cancer. RESULTS: All 24 pts completed the efficacy and safety evaluation. The median age of patients was 69 years (range: 58 to 81). Eight pts (33.3%) received RC48 monotherapy, while 16 pts (66.7%) received RC48 combined with tislelizumab. A complete response (CR) was achieved in 16 pts (66.7%, 95% CI: 44.7% to 84.4%), and stable disease (SD) in 8 pts (33.3%, 95% CI: 15.6 to 55.3%). In 15 pts (62.5%) with Her2 IHC 3+, 11 achieved PR, with the PR rate of 73.3% (95% CI: 44.9% to 92.2%). Among the 9 pts with Her2 IHC 2+, 5 achieved PR, with the PR rate of 55.6% (95% CI: 21.2% to 86.3%). A pt died due to non-treatment-related causes. The most commonly reported grade 1-2 treatment-related adverse events (TRAEs) were pruritus (58.3%), rash (41.7%), alopecia (37.5%) and fatigue (37.5%). Grade 3-4 TRAEs were reported in 4 patients (16.7%), including fatigue, pruritus, leukopenia, and neutropenia. No grade 5 adverse events were reported. CONCLUSIONS: The results of this study show that both RC48 monotherapy and RC48 combined with tislelizumab have promising efficacy in the treatment of NMIBC. The overall response rate was high, with tolerable and manageable treatment-related adverse events. These findings suggest that RC48 monotherapy and RC48 combined with tislelizumab may be successful strategies for the treatment of NMIBC. Source of Funding: The present study was supported by Tianjin Municipal Health Industry Key Project (grant no. TJWJ2022XK014), Scientific Research Project of Tianjin Municipal Education Commission (grant no. 2022ZD069), Tianjin Institute of Urology Talent Funding Program (grant no. MYSRC202310), Clinical Medicine Research Project of the Second Hospital of Tianjin Medical University (grant no. 2023LC03) © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e243 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Hailong Hu More articles by this author Shizheng Guo More articles by this author Shiwang Huang More articles by this author Kaipeng Jia More articles by this author Peng Li More articles by this author Chong Shen More articles by this author Zhe Zhang More articles by this author Yuanjie Niu More articles by this author Expand All Advertisement PDF downloadLoading ...