Long-term survival update of TRUCE-01: A phase 2 study of preoperative tislelizumab combined with low-dose nab-paclitaxel for muscle-invasive bladder cancer (MIBC).

Abstract

4585 Background: The TRUCE-01 study (NCT04730219) previously met its primary endpoint, demonstrating that preoperative tislelizumab combined with low-dose nab-paclitaxel achieved a high clinical complete response (cCR) rate of 52% and a favorable safety profile in patients with muscle-invasive bladder cancer (MIBC). Here, we report the long-term survival outcomes after 4 years of study follow-up. Methods: Eligible patients with cT2-4aN0M0 MIBC received three cycles of tislelizumab (200 mg, day 1) plus low-dose nab-paclitaxel (200 mg, day 2) every 3 weeks, followed by radical cystectomy (RC) or maximal transurethral resection of bladder tumor (mTURBT) based on response assessment. The primary endpoint was cCR. Secondary endpoints included event-free survival (EFS), overall survival (OS), disease-specific survival (DSS), and metastasis-free survival (MFS). Results: At the clinical data cutoff of October 2025, the median follow-up was 47.4 months (IQR 24.8–53.3). Among the intention-to-treat population (n = 62), 25 patients experienced clinical events, including 15 recurrences and 20 deaths (13 due to disease progression, 7 due to non-disease-related causes). Notably, among the 24 patients who elected for bladder preservation, a bladder preservation rate of 75% was achieved(4 due to recurrence requiring salvage radical cystectomy, 2 due to disease progression). The 4-year EFS and OS rates were 59.7% and 67.8%, respectively. Survival analysis stratified by response showed that patients achieving a cCR had significantly superior long-term outcomes compared to non-cCR patients. The cCR group demonstrated a robust and significant benefit in OS (HR 0.28, 95% CI 0.09–0.83, p = 0.0212), DSS (HR 0.10, 95% CI 0.02–0.46, p = 0.0029), and MFS (HR 0.19, 95% CI 0.06–0.63, p = 0.0068). No new safety signals or late-onset immune-related adverse events were observed with extended follow-up. Conclusions: With approximately 4 years of median follow-up, preoperative tislelizumab combined with low-dose nab-paclitaxel continues to demonstrate robust and durable survival benefits for patients with MIBC. Clinical trial information: NCT04730219 .