SunRISe-1 Cohort 4: Promising TAR-200 Outcomes in Papillary NMIBC

Felix Guerrero-Ramos, MD, PhD, an attending urologist at Hospital Universitario 12 de Octubre in Madrid, Spain, discusses findings from cohort 4 of the phase 2 SunRISe-1 trial (NCT04640623) which evaluated TAR-200 in patients with high-risk, BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with papillary-only disease.¹

Findings were presented at the 2025 American Urological Association (AUA) Annual Meeting. This cohort (n = 52) specifically enrolled patients with persistent or recurrent papillary disease within 12 months of BCG completion who had not undergone radical cystectomy.

Specifically, the results showed encouraging durable disease-free survival (DFS) outcomes with TAR-200 monotherapy. At a median follow-up of 12.8 months, the median DFS was not reached (95% CI, 12.1-NE). Notably, the 6- and 9-month DFS rates were 85.3% (95% CI, 71.6%-92.7%) and 81.1% (95% CI, 66.7%-89.7%), respectively. A significant observation was the low rate of radical cystectomy in this cohort, with only 5.8% of patients requiring the procedure.

TAR-200, an innovative intravesical drug-releasing system, provides sustained delivery of gemcitabine throughout the bladder wall. In January 2025, the FDA received a new drug application seeking the approval of TAR-200 for the potential treatment of BCG-unresponsive, high-risk NMIBC with carcinoma in situ, with or without papillary tumors, based on prior data from SunRISe-1.²

The SunRISe-1 trial is evaluating this novel approach in patients with BCG-unresponsive, high-risk NMIBC, with cohort 4 specifically focusing on those with papillary-only disease.¹

The primary end point for this cohort of the study was DFS, with safety and tolerability as key secondary end points. These early findings suggest that TAR-200 may offer a valuable bladder-sparing treatment option for this challenging patient population, warranting further investigation with longer follow-up.

REFERENCES:

1. Guerrero-Ramos F, Jacob JM, Van der Heijden MS, et al. TAR-200 monotherapy in patients with bacillus Calmette-Guerin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: first results from Cohort 4 of SunRISe-1. Presented at: 2025 AUA Annual Meeting; April 26-29, 2025; Las Vegas, NV.

2. New drug application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer. News Release. Johnson & Johnson. https://tinyurl.com/33ras87k