UroGen Pharma announces publication of Phase 3b ZUSDURI study results

UroGen Pharma (URGN) announced the publication in Reviews in Urology of results from a Phase 3b study evaluating the feasibility of administering ZUSDURI for intravesical solution in the home setting. The study, titled “Home Instillation of UGN-102 for Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer: A Single-Arm, Open-Label, Phase 3b Trial,” demonstrated that trained home health professionals can safely and effectively administer ZUSDURI outside of a traditional clinical setting. The study assessed the feasibility, safety, and early efficacy of at-home instillations of ZUSDURI in patients with recurrent LG-IR-NMIBC. Six of eight patients completed all six scheduled treatments, with five of those six patients indicating they would recommend the home-based approach to others. A 75% complete response rate was observed at three months, and no new safety concerns were identified. Feasibility questionnaires were completed by patients, and HHPs throughout the study. After each home instillation, patients rated their experience based on comfort, safety, communication, preference compared to office instillation, and overall satisfaction. At study end, they were also asked whether they would recommend home instillation of ZUSDURI to other patients and as an alternative to undergoing TURBT. Investigators assessed the clinical comparability of home versus in-office administration. HHPs provided feedback after each visit and at the study’s conclusion, reporting on their comfort with the procedure, perceived difficulty, and adequacy of training and support. In this study, ZUSDURI was administered via urinary catheter once weekly for six weeks, with the first dose administered in the clinic, followed by five at-home instillations by HHPs. Investigators found no meaningful differences between home and office instillation for most patients. The safety profile was consistent with previous studies, with most adverse events being mild-to-moderate urinary symptoms. Study limitations include, among others, the small sample size of eight patients, and the open-label and single-arm design.