PUNCH01: Interim results from a phase II study of intra-arterial chemotherapy (IAC) combined with tislelizumab and bacillus Calmette-Guerin (BCG) in high-risk non-muscle-invasive bladder cancer (HR NMIBC).

• DOI: 10.1200/jco.2025.43.5_suppl.767
• Publication Date: 2025-02-18T14:40:47Z
• Authors: Zongren Wang; Bin Huang; Cheng Luo; Yuxi Wu; Jiahao Lei; Lingwu Chen; Junxing Chen
• Keywords: Interim; Interim analysis; Bacillus (shape)

767 Background: Our study was established to evaluate the efficacy and safety of IAC combined with tislelizumab BCG as a bladder-preserving treatment for HR NMIBC pts. Methods: This open-label, single arm phase II enrolled BCG-naïve pts papillary tumors (high-grade Ta or T1 tumors). Firstly, should be removed all visible lesions by TURBT. Secondly, angiographic catheter placed into internal iliac arteries Seldinger’s percutaneous technique, cisplatin (60 mg/m 2 ) epirubicin (50 were administered arterially in day 1 (D1), every 3 weeks 2-4 cycles. And received 200 mg ivgtt D1, Finally, 18 instillations plus at least 8 cycles (200 ivgtt, weeks). Specifically, started on an induction course 6 week, followed maintenance 9 4 weeks. The primary end point disease-free survival(DFS) rate 12 months. Secondary points bladder-preservation rate, OS safety. estimated DFS months no less than 55% would enroll 29 Results: By Jul. 2024, 23 eligible enrolled. Twenty-two analyzed (male 90.9%; median age 61 years(37-80); pure TCC 80.0%; tumor size 3.0 cm (0.4-8.0); multiple tumours=72.7%; high-gradeTa=54.5%, T1=45.5%). Median follow-up 11.4 (6.0-40.3), mean number 2.7, 8.3, 10 (6-18). 12month 100.0% (95%CI, 63.8%-100%). 100% (95%CI,100%-100%). 100%-100%). experienced related adverse events, including nausea (n=6, G2), neutropenia (n=4, fatigue (n=3, increased AST/ALT (n=3,G2), fever (n=2, G3) myalgia (n=1, G2). Conclusions: interim results supported use promising strategy Clinical trial information: ChiCTR2200067156 .