272MO - 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)

Background

Our study was established to evaluate the efficacy and safety of IAC combined with tislelizumab and BCG as abladder-preserving treatment for HR NMIBC pts.

Methods

This open-label, single arm phase II study enrolled BCG-naïve HR NMIBC pts with papillary tumors (high-gradeTa or T1 tumors). Firstly, the papillary tumors should be removed all visible lesions by TURBT. Secondly,angiographic catheter was placed into the internal iliac arteries with Seldinger’s percutaneous technique, cisplatin (60 mg/m²) and epirubicin (50 mg/m²) were administered arterially in day 1 (D1), every 3 weeks for 2-4 cycles. And pts received tislelizumab 200 mg ivgtt in D1, every 3 weeks for 2-4 cycles. Finally, pts received 18instillations of BCG plus at least 8 cycles of tislelizumab (200 mg ivgtt, every 3 weeks). Specifically, pts werestarted on an induction course of BCG with 6 instillations every week, followed by maintenance with 3instillations every 2 weeks and 9 instillations every 4 weeks. The primary end point was disease-free survival(DFS) rate at 12 months. Secondary end points were bladder-preservation rate, OS and safety. Our studyestimated a DFS rate at 12 months was no less than 55% and the study would enroll 29 pts.

Results

By Apr. 2024, 23 eligible pts were enrolled. Twenty-two pts were analyzed (male 90.9%; median age 61 years(37-80); pure TCC 80.0%; median tumor size 3.0 cm (0.4-8.0); multiple papillary tumours=72.7%; high-gradeTa=54.5%, T1=45.5%). Median follow-up was 9.4 months (6.0-40.3), the mean number of IAC cycles was 2.7,mean number of tislelizumab cycles was 8.3, and the median BCG instillations was 10 (6-18). The DFS rate at 12month was 100.0% (95%CI, 63.8%-100%). The bladder-preservation rate at 12 months was 100% (95%CI,100%-100%). The OS rate at 12 months was 100% (95%CI, 100%-100%). 18 pts experienced treatment relatedadverse events, including nausea (n=6, G2), neutropenia (n=4, G2), fatigue (n=3, G2), increased AST/ALT (n=3,G2), fever (n=2, G3) and myalgia (n=1, G2).

Conclusions

Our interim results supported the use of IAC combined with tislelizumab and BCG as a promising bladder-preserving strategy for HR NMIBC pts.

Clinical trial identification

ChiCTR2200067156.

Editorial acknowledgement

Legal entity responsible for the study

The First Affiliated Hospital, Sun Yat-sen University.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.