- UroGen Pharma (URGN, Financial) announced positive results from a Phase 1 study of UGN-301 for bladder cancer.
- The investigational drug showed no dose-limiting toxicities and promising clinical activity.
- Some patients experienced a complete response or remained recurrence-free at the 12-week assessment.
UroGen Pharma Ltd. (URGN), a company specializing in innovative cancer treatments, has announced encouraging safety data from a Phase 1 dose-escalation study evaluating UGN-301 (zalifrelimab) intravesical solution. This investigational therapy is being developed for recurrent non-muscle invasive bladder cancer (NMIBC).
The study revealed that UGN-301 was well tolerated across all dose levels, with no dose-limiting toxicities or adverse events leading to treatment discontinuation. The drug is formulated in a proprietary reverse thermal gel (RTGel®), which allows sustained exposure in the bladder while minimizing systemic side effects.
Among evaluable patients, 46% with Ta/T1 disease and 33% with carcinoma in situ (CIS) were recurrence-free or had achieved a complete response at the 12-week mark. Remarkably, 60% of patients with Ta/T1 disease treated with a 300 mg dose remained recurrence-free at the 15-month assessment.
UGN-301 aims to address the high recurrence and progression rates associated with high-grade non-muscle invasive bladder cancer. The trial's promising results underscore the potential of localized drug delivery combined with immune modulation as an effective strategy for treating urothelial cancers.
UroGen Pharma continues to investigate UGN-301 in combination therapies, with further data presentations anticipated later this year at major urological conferences.
