Dr Prasad on Next Steps for the ENVISION Trial in NMIBC

“The durability data are really important. I believe it is the strength of [mitomycin intravesical solution] in addition to the complete response rate, which is robust. I believe the further we carry [ENVISION] out, the more it makes an argument that [this therapy] is superior to transurethral resection of bladder tumor in this patient population.”

Sandip M. Prasad, MD, a urologic oncologist at Atlantic Health, discussed the next steps for the study of mitomycin intravesical solution (Zusduri) for the treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC) in the phase 3 ENVISION trial (NCT05243550).

Patients enrolled in ENVISION will be followed for up to 5 years, allowing the study authors to collect durability of response data, Prasad began. Treatment with mitomycin intravesical solution appears to offer a response durability that is superior to that of transurethral resection of bladder tumor (TURBT) because the entire bladder is being treated with the agent, he continued. Because the agent covers the entire lining of the bladder, it can act on tumors that may be invisible to the treating oncologist, Prasad explained.

Approximately 60% of patients with high-risk NMIBC experienced disease recurrence at 1 year, Prasad explained. At a median follow-up of 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) for patients with EORTC Recurrence Scores between 1 and 4 (n = 31), 5 and 9 (n = 191), and 10 and 17 (n = 15), the 24-month event free probabilities reported in a post-hoc analysis of ENVISION 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%), respectively.

Additional follow-up data to be reported in the future will enable oncologists to confidently use mitomycin intravesical solution without any interval treatment beyond surveillance, Prasad concluded.

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