Dr Prasad on Findings From a Post -Hoc Analysis of the ENVISION Trial in NMIBC

“This was a post-hoc analysis trying to understand [if] pre-existing risk scores really mattered for these patients. What we found was that [83.9%] of low-risk patients had a complete response [and 81.2%] of intermediate-risk patients had a complete response.”

Sandip M. Prasad, MD, a urologic oncologist at Atlantic Health, discussed findings from a post hoc analysis of the phase 3 ENVISION trial (NCT05243550) that were presented in a poster during the 2026 Genitourinary Cancers Symposium.

ENVISION evaluated mitomycin intravesical solution (Zusduri) for the treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC). The post-hoc analysis evaluated complete response (CR) rates and duration of response (DOR) by EORTC Recurrence Score.

Findings from the analysis revealed that patients with an EORTC Recurrence Score between 1 and 4 (n = 31) achieved a 3-month CR rate of 83.9% (95% CI, 66.3%-94.5%), Prasad began. Those with a score between 5 and 9 (n = 191) achieved a 3-month CR rate of 81.2% (95% CI, 74.9%-86.4%), he continued. Patients with an EORTC score between 10 and 17 (n = 15) had a 3-month CR rate of 60.0% (95% CI, 32.3%-83.7%), he added.

Moreover, the probability of patients remaining a response at 24 months was high across the 3 subgroups, Prasad emphasized. Specifically, the 24-month event-free probabilities were 67.4% (95% CI, 43.2%-83.1%), 73.7% (95% CI, 64.6%-80.8%), and 66.7% (95% CI, 28.2%-87.8%), in the EORTC 1 to 4, 5 to 9, and 10 to 17 subgroups, respectively. The median durations of follow-up for these respective groups were 23.3 months (95% CI, 23.0-23.9), 23.7 months (95% CI, 23.7-23.9), and 23.9 months (95% CI, 23.7-not estimable.

Prasad noted that these data enable providers to utilize mitomycin intravesical solution regardless of recurrence risk status, number of tumor sites, and tumor sizes.

Prior data from ENVISION supported the June 2025 FDA approval of mitomycin intravesical solution for the treatment of adult patients with recurrent low-grade intermediate-risk NMIBC.

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