Intravesical Mitomycin Demonstrates Significant Duration of Response in NMIBC
The FDA is currently evaluating the application of intravesical mitomycin for low-grade intermediate-risk non–muscle-invasive bladder cancer.
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.
