Data from Phase II Pilot Trial of Tislelizumab plus Low-Dose Nab-Paclitaxel for Extensive Very High–Risk Non–Muscle-Invasive Bladder Cancer

• DOI: 10.1158/1078-0432.c.7700631
• Publication Date: 2025-03-03T08:50:47Z
• Authors: Yunkai Qie; Shiwang Huang; Chong Shen; Zhouliang Wu; La Da; Kaipeng Jia; Zhe Zhang; Gangjian Zhao; Lili Wang; Guoping Xu; Yang Zhao; Rui Liang; Jianing Guo; Changping Li; Hua Dong; Man Li; Hongjun Li; Houyuan Chen; Dawei Tian; Changli Wu; Wei Zhang; Zesheng An; Haitao Wang; Yuanjie Niu; Hailong Hu
• Keywords: Nab-paclitaxel

<div>AbstractPurpose:<p>Combinations of immune checkpoint inhibitors and nab-paclitaxel have improved outcomes in advanced urothelial carcinoma muscle-invasive bladder cancer. This study evaluates the safety efficacy tislelizumab combined with low-dose extensive very high–risk non–muscle-invasive cancer.</p>Patients Methods:<p>TRUCE-02 was a single-arm phase II trial that included 63 patients visually incomplete resection and/or high-volume high-grade T1 tumors (with or without <i>in situ</i>) who were ineligible for declined radical cystectomy. Patients received intravenous (200 mg on day 1) 2) every 3 weeks, assessment approximately months after initial administration. The primary endpoint complete response (CR) rate high-risk disease. Main secondary endpoints duration CR.</p>Results:<p>The analysis all patients, 59 patients. Thirty-seven (62.7%; 95% confidence interval, 49.1%–75.0%) achieved CR disease, 24-month sustained 96.3% (95% 89.4%–100.0%). Grade to 4 treatment-related adverse events occurred nine (14%), no fatal reported.</p>Conclusions:<p>Tislelizumab plus well tolerated showed promising antitumor activity, making it potential alternative cancer are decline cystectomy.</p></div>