Intravesical Mitomycin Demonstrates Significant Duration of Response in NMIBC

Bladder cancer stages: © pikovit - stock.adobe.com

Intravesical mitomycin (UGN-102) for the treatment of low-grade intermediate-risk non–muscle-invasive bladder cancer (LG-IR-NMIBC) led to a notable duration of response (DOR) in patients who achieved a complete response (CR), according to data from the phase 3 ENVISION trial (NCT05243550).¹

The 12-month DOR in patients who received intravesical mitomycin and achieved a CR at 3 months (n = 108) was 82.3% (95% CI, 75.9%-87.1%). The DOR estimates for 15 months (n = 43) and 18 months (n = 9) following the 3-month CR were both 80.9% (95% CI, 73.9%-86.2%).

ENVISION previously met its primary end point, demonstrating a CR rate at 3 months following the first instillation of 79.6% (95% CI, 73.9%-84.5%).

“These data demonstrate that treatment with [intravesical mitomycin] results in a clinically meaningful CR rate and that the durability of the response in patients with LG-IR-NMIBC is robust,” said Sandip Prasad, MD, MPhil, director of genitourinary surgical oncology, Morristown Medical Center/Atlantic Health System, New Jersey, and principal investigator of the ENVISION trial, in a press release. “This study adds to the mounting evidence supporting [intravesical mitomycin] as a potentially valuable treatment option for patients with recurrent LG-IR-NMIBC.”

In October 2024, the FDA accepted the new drug application of intravesical mitomycin in this patient population and set a Prescription Drug User Fee Act target action date of June 13, 2025.²

About Intravesical Mitomycin and the Phase 3 ENVISION Study

Intravesical mitomycin utilizes a sustained release hydrogel-based formulation to enable longer drug exposure to bladder tissue without surgery. The agent can be delivered by catheter in the outpatient setting.¹

The agent is being evaluated in the phase 3 ENVISION study, which enrolled an estimated 220 patients with LG-IR-NMIBC across 65 global sites to receive 6 once-weekly intravesical instillations of mitomycin. The study’s primary end point was CR rate, and secondary end points included DOR, durable CR rate, disease-free survival, and incidence of treatment-emergent adverse events.³

Intermediate-risk disease was defined as having the presence of multiple tumors, a solitary tumor greater than 3 cm, and/or early or frequent recurrence within 1 year of the current diagnosis. Patients were also required to have negative voiding cytology for high-grade disease and adequate organ and bone marrow function to participate in the trial. Those who received Bacillus Calmette-Guérin within 1 year, with a history of high-grade bladder cancer in the past 2 years, or with history of muscle-invasive disease were not eligible for enrollment.

REFERENCES:

1. ENVISION trial results published in the Journal of Urology Report 82.3% duration of response 12 months after achieving complete response for UGN-102, potentially first FDA-approved non-surgical treatment for LG-IR-NMIBC. News release. October 28, 2024. Accessed October 30, 2024. https://tinyurl.com/32fvz7z3

2. UroGen announces FDA acceptance of its new drug application for UGN-102. News release. UroGen Pharma Ltd. October 15, 2024. Accessed October 30, 2024. https://tinyurl.com/25xbhp98

3. A phase 3 single-arm study of UGN-102 for treatment of low grade intermediate risk non-muscle-invasive bladder cancer (ENVISION). ClinicalTrials.gov. Updated July 12, 2024. Accessed October 30, 2024. https://www.clinicaltrials.gov/study/NCT05243550