Félix Guerrero-Ramos, MD, on TAR-200 in papillary disease-only NMIBC

Data from cohort 4 of the SunRISe-1 trial ((NCT04640623) were presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada, showing an impressive disease-free survival rate among patients with CG-unresponsive papillary disease-only high-risk non–muscle invasive bladder cancer (NMIBC).¹

Specifically, TAR-200 monotherapy was associated with a disease-free survival (DFS) of 85.3% (95% CI, 71.6% to 92.7%) at 6 months and 81.1% (95% CI, 66.7% to 89.7%) at 9 months. At a median follow-up of 12.8 months, the median DFS was not reached (95% CI, 12.1 to NE).

Presenting author Félix Guerrero-Ramos, MD, PhD, FEBU, discussed these results in an interview with Urology Times® during the meeting.

He noted, “[These are] very good numbers for these patients who otherwise would undergo a radical cystectomy.”

Guerrero-Ramos is the coordinator of the uro-oncology unit at the Hospital Universitario 12 de Octubre, Madrid, Spain.

Data from the study also showed that among patients with high-grade Ta disease, the DFS was 85.7% (95% CI, 66.3% to 94.4%) at 6 months and 82.1% (95% CI, 62.3% to 92.1%) at 9 months. Among patients with T1 disease, DFS was 84.7% (95% CI, 59.7% to 94.8%) at 6 months and 79.4% (95% CI, 54% to 91.7%) at 9 months.

On this finding, Guerrero-Ramos added, “So, it doesn't matter the T-staging; the treatment is highly efficacious in both groups.”

In total, 5.8% (3 of 52) of patients underwent radical cystectomy.

Further, at 9 months, the progression-free survival (PFS) was 95.6% (95% CI, 83.5% to 98.9%), and the overall survival (OS) was 98.0% (95% CI, 86.4% to 99.7%). The median PFS and OS were not estimable at the time of data report. In total, 1.9% (1 of 52) patients progressed to muscle-invasive disease.

No new safety signals were observed. The majority of treatment-emergent adverse events were grade 1 or 2. In total, 5.8% (3) patients experienced at least 1 serious treatment-related adverse event.

REFERENCE

1. Guerrero-Ramos F, Jacob JM, van der Heijden MS, et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: First results from cohort 4 of SunRISe-1. J Urol. 2025;213(5S):e2. doi:10.1097/01.JU.0001111604.90306.91.04