Zusduri Shows Durable Responses in Some Bladder Cancers

Zusduri had a median response duration of 3.5 years and event-free survival of two years in low-grade intermediate-risk bladder cancer: © stock.adobe.com.

Patients with low-grade intermediate-risk non-muscle invasive bladder cancer who achieved a complete response with Zusduri (mitomycin) in the Phase 2b OPTIMA II trial remained event-free for a median of two years, with a median duration of response of 3.5 years, according to study findings announced in a news release by UroGen.

“Low-grade intermediate-risk bladder cancer is a chronic, recurring disease that often requires repeated surgical intervention,” Dr. Neal D. Shore, medical director for the START Carolinas/Carolina Urologic Research Center and lead author of the study, said in the news release. “The long-term data from the extension study of OPTIMA II highlight Zusduri’s ability to deliver sustained responses in an outpatient setting, which may be especially valuable for recurrent patients and thus for physicians who prefer a different, non-surgical treatment option.”

Among 41 patients who achieved a complete response three months after treatment with Zusduri in the OPTIMA II trial, 25 remained in response at 12 months, and 17 joined a long-term follow-up study. For those 41 patients, the median duration of response was 24.2 months, with a median follow-up of 35.8 months. Among the 17 patients followed long term, the median duration of response was 42.1 months with a median follow-up of 50.4 months. These findings expand on earlier 12-month data and suggest that Zusduri may offer durable, event-free outcomes.

“These results reflect our continued commitment to bringing forward innovative treatments that give patients and physicians more options,” Dr. Mark Schoenberg, chief medical officer of UroGen, said in the news release. “For recurrent patients facing repeated surgeries, it offers a non-surgical approach that can empower patients and providers to choose a path that best fits individual needs and preferences.”

Safety data were not collected during the long-term follow-up trial. In the original OPTIMA II study, the most commonly reported side effects were dysuria in 26 patients (41%), pollakiuria in 13 (21%), hematuria in 10 (16%), and either urgency to urinate or urinary tract infection in 9 (14%). Fatigue was reported in 7 patients (11%). The most common side effects of Zusduri include increased blood creatinine or potassium levels, trouble urinating, decreased red blood cell counts, changes in liver tests, changes in white blood cell counts, urinary tract infection, and blood in the urine.

Zusduri may also cause urine to appear violet to blue. Patients should avoid skin contact with urine for at least 24 hours. Both males and females are advised to sit on the toilet to urinate and flush several times afterward. After using the bathroom, they should wash their hands, inner thighs, and genital area with soap and water. Any clothing that comes into contact with urine should be washed immediately and separately from other clothing.

Zusduri is given once a week for six weeks by a healthcare provider, who places the medication directly into your bladder using a urinary catheter. Be sure to follow your provider’s instructions and receive all six treatments as scheduled.

The OPTIMA II trial included adults with low-grade, intermediate-risk non–muscle invasive bladder cancer, both newly diagnosed and recurrent. Of the 17 patients who entered long-term follow-up, 16 had recurrent disease, and 1 was newly diagnosed. This group had a median duration of response of 3.5 years based on Kaplan-Meier estimates. ZUSDURI is approved only for adults with recurrent LG-IR-NMIBC. OPTIMA II was an open-label, single-arm, multicenter Phase 2b trial evaluating the safety and efficacy of ZUSDURI in this patient population.

Reference

1. “Five-Year Long-Term Extension Study of the OPTIMA II Trial Demonstrates Long-Term Durability of Response to ZUSDURI in Patients With Low-Grade Intermediate-Risk Non–Muscle Invasive Bladder Cancer.” UroGen, Clinical Genitourinary Cancer. July 21

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