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Patients with low-grade intermediate-risk non-muscle-invasive bladder cancer who achieved a complete response rate after 3 months of UGN-102 treatment had an 82.3% duration of response at 12 months.
Findings from the phase 3 ENVISION study (NCT05243550) show that intravesical mitomycin (UGN-102; UroGen Pharma Ltd), an investigational drug, demonstrated long-term durability of response in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). Findings were published the Journal of Urology. If approved, the treatment could be the first FDA-approved non-surgical treatment for patients with the disease.1
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UGN-102 is an intravesical solution for the drug formulation of mitomycin, which is currently in phase 3 development for the treatment of LG-IR-NMIBC. The treatment is a sustained release, hydrogel-based formulation that is designed to enable longer exposure of bladder tissue to mitomycin, which enables the treatment of tumors by non-surgical means. The FDA accepted the NDA for UGN-102 and assigned a PDUFA goal date of June 13, 2025.1
LG-IR-NMIBC represents approximately 22,000 newly diagnosed cancer patients each year as well as an estimated 60,000 recurrences annually among previously diagnosed patients. It is the most common urologic cancer in men and tends to affect those with an increased risk of comorbidities. Guidelines recommend that trans-urethral resection of bladder tumor (TURBT) is used as standard of care for the management of NMIBC. According to experts, up to 70% of patients NMIBC experience at least 1 recurrence, and those with LG-IR-NMIBC are even more likely to recur and face repeated TURBT procedures.1
Trial Name: A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer (ENVISION)
ClinicalTrials.gov ID: NCT05243550
Sponsor: UroGen Pharma Ltd.
Completion Date (Estimated): February 2028
“LG-IR-NMIBC patients are typically elderly and currently treated with repeated surgeries under general anesthesia that are associated with physical and quality of life detriments,” said Liz Barrett, president and CEO of UroGen, in a news release. “…The highly recurrent nature of LG-IR-NMIBC underscores the urgent need for innovative options for patients facing this challenging disease."1
The efficacy and safety of UGN-102 were evaluated in the single-arm, multinational, multicenter phase 3 study ENVISION (NCT05243550). The study enrolled about 240 patients with LG-IR-NMIBC across 56 sites. All patients were given 6 once-weekly intravesical instillations of UGN-102.1,2
The study’s primary end point was complete response rate (CRR), which was assessed at a 3-month visit. Secondary end points included duration of response (DOR), durable CRR, disease-free survival, and treatment-emergent adverse events (AEs), all of which were assessed up to 63 months.1,2
The findings indicated that treatment with UGN-102 resulted in an approximate 82.3% (95% CI, 75.9%, 87.1%) DOR at 12 months in patients who achieved a CRR 3 months following initial instillation. Additionally, a Kaplan-Meier analysis estimates that 15-month (n = 43) and 18-month (n = 9) DOR after achieving a 3-month CR were both 80.9% (95% CI, 73.9%, 86.2%). The ENVISION trial previously met its primary end point by demonstrating that patients treated with UGN-102 had a 79.6% (95% CI, 73.9%, 84.5%) CR rate at 3 months following the first instillation of UGN-102.1,2
The most common treatment-emergent AEs observed during the ENVISION trial were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention. All AEs were mild to moderate in severity, and either resolved or are currently resolving. According to the investigators, UGN-102 demonstrated a similar safety profile during the ENVISION trial than that observed in other trials evaluating UGN-102.1
“These data demonstrate that treatment with UGN-102 results in a clinically meaningful CR rate and that the durability of the response in patients with LG-IR-NMIBC is robust,” said principal investigator Sandip Prasad, MD, MPhil, director of genitourinary surgical oncology, Morristown Medical Center/Atlantic Health System, NJ, in a news release. “This study adds to the mounting evidence supporting UGN-102 as a potentially valuable treatment option for patients with recurrent LG-IR-NMIBC.”1
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