Guerrero-Ramos is the coordinator of the urologic oncology unit and the bladder cancer unit at Hospital Universitario 12 de Octubre, in Madrid, Spain.

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 

 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.

 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.

Videos

Felix Guerrero-Ramos, MD, PhD, discusses the potential role of TAR-200 in high-risk, BCG-unresponsive, papillary-only non–muscle-invasive bladder cancer.

Félix Guerrero-Ramos, MD, PhD, FEBU, urologist, University Hospital 12 de Octubre, discusses the role of Bacillus Calmette-Guerin (BCG) in the treatment of patients with non-muscle invasive bladder cancer.

Currently, BCG, an intravesical immunotherapy, is the only available treatment for patients with high-risk non-muscle invasive bladder cancer, explains Ramos. Moreover, the disease is associated with high recurrence and progression rates that often lead to muscle invasive bladder cancer.

Additionally, carcinoma in situ lesions are common among patients with non-muscle invasive bladder cancer and indicate a likelihood of developing muscle invasive disease, says Ramos.

As up to 40% of patients progress on BCG, novel immunotherapy options are being evaluated in clinical trials in order to define more effective treatment options, explains Ramos.

Additionally, identifying predictive biomarkers of response to determine whether a patient is likely to respond to BCG or cystectomy could spare patients the toxicities associated with more aggressive treatments, concludes Ramos.

Félix Guerrero-Ramos, MD, PhD, FEBU, discusses the role of Bacillus Calmette-Guerin in the treatment of patients with non-muscle invasive bladder cancer.



Félix Guerrero-Ramos, MD, PhD, FEBU

Articles

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

Dr. Ramos on the Role of BCG In Non-Muscle Invasive Bladder Cancer