SunRISe-1 Highlights TAR-200 as Alternative to Surgery for High-Risk Bladder Cancer

Promising initial results from cohort 4 of the phase 2b SunRISe-1 study (NCT04640623), evaluating TAR-200, an intravesical gemcitabine-releasing system, for patients with Bacillus Calmette Guérin (BCG)-unresponsive, high-risk non-muscle invasive bladder cancer (HR-NMIBC) with papillary-only disease.¹

The early data showed an impressive disease-free survival (DFS) rate of over 80% at 9 months, with 94% of patients maintaining their bladder. These results, presented at the 2025 American Urological Association (AUA) Annual Meeting, suggest TAR-200 could be a significant alternative to bladder removal surgery for this patient group.

The study demonstrated 85.3% and 81.1% DFS rates at 6 and 9 months, respectively, in patients treated with TAR-200 monotherapy. These high rates are notable given the high risk of recurrence in this population. Furthermore, DFS rates remained strong across both high-grade Ta and T1 disease subtypes.

Notably, 94.2% of patients avoided radical cystectomy at a median follow-up of 12.8 months. The safety profile of TAR-200 was consistent with previous studies, with most treatment-related adverse events being low-grade and manageable.

Experts, including Felix Guerrero-Ramos, MD, PhD, attending urologist at Hospital Universitario 12 de Octubre, Madrid, Spain, and investigator of the study, believe these findings highlight TAR-200's potential as an effective and well-tolerated treatment option that can preserve the bladder, significantly improving patients' quality of life.

A new drug application with the FDA for TAR-200 has been initiated and is further evaluating its efficacy in ongoing phase 3 studies.²

HR-NMIBC, affecting a significant portion of bladder cancer patients, currently has limited treatment options after BCG failure, making these results particularly encouraging.

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