Home instillation of mitomycin intravesical solution found feasible, safe in NMIBC

Administration of mitomycin for intravesical solution (Zusduri, formerly UGN-102) in the home setting was found to be a feasible, safe, and effective method for treating patients with recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC), according to data from the phase 3b BL010 study (NCT05136898) published in Reviews in Urology.¹

Mitomycin intravesical instillation was granted FDA approval in June 2025 for recurrent LG-IR-NMIBC. The therapy is currently administered in an outpatient clinical setting.

“The ability to deliver this treatment safely and effectively at home has the potential to ease the burden on patients and reduce reliance on hospital or clinic resources,” explained lead author David Morris, MD, who is a practicing urologist at Urology Associates, PC, in Nashville, Tennessee, in a news release on the findings.² “As physicians, we’re always looking for ways to provide effective care with greater comfort and convenience. These findings represent an important step in that direction.”

Overall, 75% of patients (6 of 8) completed all 6 scheduled treatments. Five of those patients reported that they would recommend home instillation of mitomycin intravesical solution to other patients with NMIBC.

The study also included investigator end-of-study questionnaires. In total, 4 investigators participated in the study. Investigators reported that home instillation was “not different” than office instillation for 62.5% of patients (6 of 8). Further, home health professionals (HHPs) reported that they were comfortable administering the therapy, did not have difficulty or concerns administering the instillation, and had sufficient support to provide the instillation within the home setting for 91.9% of the instillations (34 of 37).

In total, 75% of patients (6 of 8) achieved the study’s secondary end point of a complete response at 3 months.

According to the authors, the safety profile for mitomycin intravesical solution was “consistent with previous studies and primarily characterized by mild to moderate urinary symptoms.”

All patients experienced at least 1 treatment-emergent adverse event (TEAE), with the majority being mild to moderate in severity and resolved or resolving, the authors noted. Treatment-related TEAEs were reported in 50% (4 of 8) of patients and included dysuria and fatigue. Three procedure-related TEAEs were reported in 1 patient, which included hematuria, micturition urgency, and pollakiuria.

Further, 3 patients (37.5%) experienced at least 1 serious TEAE. Nontreatment-related AEs led to study discontinuation in 2 patients (25%).

In total, the single-arm, open-label phase 3b BL010 trial enrolled 8 adult patients with recurrent LG-IR-NMIBC through 5 clinical trial sites across the US.

To be eligible for enrollment, patients needed to have histologically confirmed recurrent LG-IR-NMIBC by cold-cup biopsy, intermediate risk disease, adequate organ and bone marrow function, and negative voiding cytology for high-grade disease within 6 weeks of the screening visit. Participants also needed to have no evidence of an active urinary tract infection and a life expectancy of at least the duration of the study.³

For the study, patients received 1 instillation of mitomycin intravesical solution at the investigative site, followed by 5 subsequent instillations performed in the home setting by an HHP. The study’s primary end point was feasibility of home instillation, and the secondary end point was 3-month complete response rate, determined via cystoscopy, urine cytology, and for-cause biopsy.

“This patient-centered approach to care reflects our commitment to redefining how urologic cancers are treated, offering patients access to effective and convenient treatment options,” concluded Mark Schoenberg, MD, chief medical officer of UroGen, in the news release.² “The ability to potentially administer Zusduri safely in the home represents a meaningful advancement for patients and caregivers alike, especially those who may face challenges traveling to frequent clinic visits.”

REFERENCES

1. Morris D, Kramolowsky II, EV, Bivins VM, et al. Home instillation of UGN-102 for primary chemoablation of recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer: a single-arm, open-label, phase 3b trial. Reviews in Urology. 2025;43(3). doi:10.1016/j.urolonc.2024.12.127

2. UroGen announces publication of phase 3b study results demonstrating the feasibility of home instillation of ZUSDURI for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer in Reviews in Urology. News release. UroGen Pharma Ltd. July 28, 2025. Accessed July 28, 2025. https://investors.urogen.com/news-releases/news-release-details/urogen-announces-publication-phase-3b-study-results

3. Feasibility of home instillation of UGN-102 for treatment of low-grade (LG) non-muscle invasive bladder cancer (NMIBC). ClinicalTrials.gov. Last updated September 19, 2024. Accessed July 28, 2025. https://clinicaltrials.gov/study/NCT05136898