Dr Prasad on the ENVISION Trial in NMIBC

“[Among] patients who received study treatment, 80% of those patients at 3 months had no disease in the bladder. That was the initial finding, and [it provides] fairly powerful evidence that chemoablation works [in this patient population].”

Sandip M. Prasad, MD, a urologic oncologist at Atlantic Health, discussed prior data from the phase 3 ENVISION trial (NCT05243550) that provided the impetus for a post hoc analysis of complete response rates and duration of response by EORTC recurrence score subgroups.

ENVISION was a single-arm, open-label study that evaluated mitomycin (UGN-102) for the treatment of patients with recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer (NMIBC), Prasad began. Historically, alternatives to bladder tumor resection for this patient population have been limited, he continued.

Mitomycin is a novel, non-surgical chemoablative therapy that is administered via a gel, Prasad explained. The agent can be administered in an outpatient setting and does not require patients to discontinue blood thinners, he noted.

ENVISION enrolled 240 patients, Prasad continued. The primary end point of the study was 3-month complete response (CR) rate. Secondary end points included duration of response (DOR), disease control rate, disease-free survival, the incidence of treatment-emergent adverse effects, and pharmacokinetic measures.

Findings from ENVISION published in the Journal of Urology demonstrated that the 3-month CR rate among patients who received all 6 planned doses of mitomycin (n = 228) was 80% (95% CI, 73.9%-84.5%), Prasad detailed. Moreover, the response probability 12 months later was determined to be 82% (95% CI, 75.9%-87.1%). At a median follow-up of 13.9 months, the median DOR was not estimable. The safety profile of the agent was determined to be favorable, with 57% of patients experiencing a treatment-emergent adverse effect.

Prasad concluded that these initial data provided powerful evidence in favor of the efficacy of chemoablative therapy.

Of note, subsequent data from the post hoc analysis of ENVISION were presented during the 2026 Genitourinary Cancers Symposium.

Disclosures: Prasad received research funding from Janssen, Merck, Pfizer, and UroGen Pharma.