Dr Guerrero-Ramos on the Potential Role of TAR-200 in BCG-Unresponsive Papillary NMIBC

The next step is the ongoing SunRISe-5 trial, a phase 3 study that is [randomly assigning] patients with BCG-unresponsive or BCG-experienced papillary-only tumors to receive either TAR-200 or intravesical chemotherapy with mitomycin C or gemcitabine selected at the investigator’s discretion.”

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

Data presented during the 2025 AUA Annual Meeting showed that treatment with TAR-200, a novel gemcitabine-releasing intravesical device, generated durable disease-free survival (DFS) outcomes in this population. Among the 52 patients treated, the median DFS was not reached (95% CI, 12.1–not estimable) at a median follow-up of 12.8 months. 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. Only 5.8% of patients underwent radical cystectomy during the study period.

This cohort represents a high-need subgroup within the broader high-risk NMIBC landscape, Guerrero-Ramos emphasized, adding that although patients with carcinoma in situ (CIS) have limited approved non-surgical treatment options in the United States, patients with papillary-only tumors currently lack any regulatory-approved therapies across global markets. The standard recommendation of radical cystectomy remains the only widely accepted option, yet many patients—up to 80% to 90%—decline this surgery due to its morbidity and quality-of-life implications, particularly at this early stage of disease, he said.

Guerrero-Ramos highlighted the ongoing phase 3 SunRISe-5 trial (NCT06211764) as the next step for evaluating TAR-200 in the papillary-only patient population. This randomized study is enrolling patients with papillary-only, BCG-unresponsive or -exposed NMIBC, and they are being randomly assigned to receive TAR-200 or intravesical chemotherapy with investigator’s choice of mitomycin C or gemcitabine. According to Guerrero-Ramos, this trial is nearing full enrollment and could offer level 1 evidence to define the clinical utility of TAR-200 as a bladder-sparing option in this population.