UroGen Pharma (URGN) Study Update summary

Study background and objectives

• ENVISION is a pivotal phase 3 single-arm study evaluating UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer (NMIBC), focusing on patients with recurrent disease within one year.

• The study aimed to assess the complete response rate at 3 months and the duration of response as key endpoints.

• UGN-102 is a novel, non-surgical, intravesical therapy using RTGel technology for sustained drug delivery.

Key efficacy results

• ENVISION enrolled 240 patients, median age 70, two-thirds male, all with recent recurrence.

• The 3-month complete response rate was 79.6%, with almost 4 out of 5 patients achieving tumor ablation without surgery.

• At 12 months, 82.3% of complete responders remained disease-free, the highest duration of response seen in this population.

• Predictive modeling estimates median duration of response at 40 months for complete responders.

Safety and tolerability

• Adverse events were mostly mild to moderate, primarily lower urinary tract symptoms manageable by urologists.

• Severe treatment-related adverse events occurred in less than 1% of patients and resolved.

• Three deaths occurred during the study, all unrelated to treatment.