Zusduri Shows Durable Response in Non–Muscle-Invasive Bladder Cancer

In a phase 3 trial, 72.2% of patients with recurrent low-grade bladder cancer kept complete response at 24 months after Zusduri treatment.

Zusduri (mitomycin) intravesical solution demonstrated durable responses in adults with recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer (LG-IR-NMIBC), according to a news release from UroGen Pharma.

In the phase 3 ENVISION trial, 72.2% of patients who achieved a complete response at three months maintained that response at 24 months. The median follow-up after a three-month complete response was 23.7 months, and the median duration of response has not yet been reached. Data from this trial resulted in the approval of this agent in June.

“This latest update from the pivotal ENVISION trial of Zusduri showed that, among patients who achieved a complete response at three months, the probability of remaining event-free 24 months after complete response was 72.2%,” Dr. Sandip Prasad, M.Phil, said in the announcement. “Among patients who achieved a complete response, the event rate over time has remained stable. This duration of response [24 months] result highlights the sustained efficacy of the therapy and reinforces its potential as a durable treatment option. For the first time, adult patients with recurrent LG-IR-NMIBC have an FDA-approved therapy.”

Prasad is the director of genitourinary surgical oncology and vice chair of urology at Morristown Medical Center/Atlantic Health System, New Jersey, and principal investigator of the ENVISION trial.

Side Effects of Zusduri

The most common side effects, occurring in 10% or more of patients, including lab abnormalities, were painful urination (dysuria), high potassium, high creatinine (a sign of reduced kidney function), low hemoglobin (anemia), high eosinophils (a type of white blood cell), elevated liver enzymes (AST and ALT, which may indicate liver irritation), low lymphocytes and neutrophils (types of white blood cells that help fight infection), urinary tract infection, and blood in the urine (hematuria).

Most side effects were mild to moderate. Serious side effects occurred in 12% of patients and included trouble emptying the bladder (urinary retention, 0.8%) and narrowing of the urethra (urethral stenosis, 0.4%).

Trial Design

The trial enrolled 240 patients at 56 sites. Participants received six weekly administrations of Zusduri. The primary goal was to investigate the complete response rate at three months after treatment began. A key secondary goal was the durability of that response over time in those who achieved complete response at three months.

What is Zusduri?

Zusduri intravesical solution, previously known as UGN-102 is an innovative drug approved for adults with recurrent low-grade, intermediate-risk non-muscle-invasive bladder cancer. It uses UroGen’s proprietary RTGel technology, a sustained-release hydrogel formulation, to deliver mitomycin directly into the bladder through a urinary catheter in an outpatient setting, allowing tumor treatment without surgery.

Each year in the U.S., about 82,000 people are diagnosed with this type of bladder cancer, and roughly 59,000 experience recurrence, according to UroGen’s announcement. The disease mainly affects older adults, with a median diagnosis age of 73, who often have other health conditions.

What is the Current Standard of Care?

The standard treatment is transurethral resection of bladder tumor (TURBT), a surgical procedure usually performed under general anesthesia. However, up to 70% of patients with non–muscle-invasive bladder cancer experience recurrence, and those with low-grade, intermediate-risk disease face even higher rates, requiring multiple TURBTs over their lifetime. These repeated surgeries can affect physical health, quality of life and may increase mortality risk.

“The 24-month duration of response data from the ENVISION trial underscore the transformative potential of Zusduri … for adult patients with recurrent LG-IR-NMIBC,” Dr. Mark Schoenberg, chief medical officer at UroGen, said in the release. “This is a population that has long endured a cycle of recurrence and repeat surgeries, a burden that weighs heavily, particularly on older adults. With Zusduri now approved, we have a new treatment option that can help deliver durable complete responses and meaningfully extend event-free intervals. This represents a major advance in the way we care for these patients.”

Reference

“UroGen Announces 24-Month Duration of Response of 72.2% from the Pivotal Phase 3 ENVISION Trial of ZUSDURI, the First and Only FDA-Approved Medicine for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer,” UroGen. News Release. August 5, 2025.

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