UroGen Pharma Publishes Key Trial Results for Zusduri
UroGen Pharma announced the publication of results from the pivotal Phase 3 ENVISION trial of Zusduri for intravesical solution in The Journal of Urology. Zusduri is indicated for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The publication reports a 72.2% probability of remaining event-free at 24 months after complete response as determined by Kaplan-Meier analysis. The CR rate at three months was 79.6%. The median follow-up time after three-month CR was 23.7 months, and the median DOR was not reached. The existing standard of care for LG-IR-NMIBC is transurethral resection of bladder tumor, a surgical procedure typically performed under general anesthesia. Due to high recurrence rates, patients, who are often elderly with multiple comorbidities, may require repeated TURBT procedures over their lifetime, which can negatively impact quality of life and may be associated with increased health risks. An estimated 59,000 patients with LG-IR-NMIBC experience recurrence annually in the United States. The most common adverse reactions, including laboratory abnormalities, observed in patients treated with Zusduri were dysuria, hematuria, urinary tract infection, increased creatinine, increased potassium, decreased hemoglobin, decreased lymphocytes, decreased neutrophils, increased eosinophils, and increased liver enzymes. Adverse reactions were primarily mild to moderate in severity. Serious adverse reactions occurred in 12% of patients and included urinary retention and urethral stenosis.
