Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION).

Autor:	Prasad SM; Morristown Medical Center/Atlantic Health System and Garden State Urology, Morristown, New Jersey., Shishkov D; Department of Urology, University Multiprofile Hospital for Active Treatment, Plovdiv, Bulgaria., Mihaylov NV; Department of Urology, University Multiprofile Hospital for Active Treatment, Plovdiv, Bulgaria., Khuskivadze A; Urology Department, LTD Gidmedi, Tbilisi, Georgia., Genov P; Department of Urology, University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Bulgaria., Terzi V; Multiprofile Hospital for Active Treatment, Varna, Bulgaria., Kates M; The Johns Hopkins Medical Institutions, Baltimore, Maryland., Huang WC; NYU Langone Urology Associates, New York, New York., Louie MJ; UroGen Pharma, Princeton, New Jersey., Raju S; UroGen Pharma, Princeton, New Jersey., Burger B; UroGen Pharma, Princeton, New Jersey., Meads A; UroGen Pharma, Princeton, New Jersey., Schoenberg M; UroGen Pharma, Princeton, New Jersey.; The Department of Urology, Montefiore Einstein, New York, Bronx.
Jazyk:	angličtina
Zdroj:	The Journal of urology [J Urol] 2024 Oct 24, pp. 101097JU0000000000004296. Date of Electronic Publication: 2024 Oct 24.
DOI:	10.1097/JU.0000000000004296
Abstrakt:	Purpose: To evaluate the efficacy and safety of UGN-102 chemoablation for the primary treatment of patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer. Materials and Methods: ENVISION is an ongoing, multinational, single-arm, Phase 3 study in patients with a biopsy-proven recurrence of untreated low-grade intermediate-risk nonmuscle-invasive bladder cancer. Patients received 6 weekly intravesical instillations of UGN-102 (mitomycin; outpatient setting) and were evaluated at 3 months. Patients achieving complete response (CR; negative cystoscopic examination, cytology, and for-cause biopsy) were surveilled regularly until recurrence, progression, or death. Patients who remain disease-free will be followed up to 5 years, and further results will be reported in the future. Results: Of 240 patients enrolled, 228 (95%) received all 6 planned doses; 191 (79.6%; 95% CI, 73.9-84.5) achieved CR at 3 months, with an 82.3% (95% CI, 75.9-87.1) probability of response 12 months later. Median duration of response was not estimable over a median 13.9-month follow-up period. The most common adverse events (≥5.0% of patients) were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention; generally mild/moderate and resolved/resolving. Serious adverse events were observed in 29/240 (12.1%), 2 were treatment-related (urinary retention/urethral stenosis), both resolved. Conclusions: Primary chemoablation with UGN-102 in patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer resulted in a 79.6% CR rate. Patients achieving a CR had an 82.3% likelihood of remaining disease-free 1 year later. The benefit-risk profile was favorable, supporting UGN-102 as a nonsurgical alternative for transurethral resection of bladder tumors in this patient population. Limitations of this study included lack of tumor sizing after the diagnostic biopsy. Trial Registration: ClinicalTrials.gov Identifier: NCT05243550.
Databáze:	MEDLINE
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