Clinical TrialMay 15, 2026, 08:02 AM
UroGen UGN-103 Achieves 94.5% DOR in Phase 3 UTOPIA Trial
AI Summary
UroGen Pharma announced that UGN-103 achieved a 94.5% durability of response at six months in its Phase 3 UTOPIA trial for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). These results are consistent with the 91.9% six-month durability observed with ZUSDURI, the company's FDA-approved treatment. Based on these findings and FDA alignment, UroGen plans to submit a New Drug Application for UGN-103 in the third quarter of 2026, aiming to expand its uro-oncology portfolio.
Key Highlights
- UGN-103 achieved 94.5% durability of response at six months in UTOPIA trial.
- Results are consistent with ZUSDURI's 91.9% six-month DOR in ENVISION trial.
- UroGen remains on track to submit NDA for UGN-103 in Q3 2026.
- UGN-103 intellectual property protection expected until December 2041.
- UTOPIA trial is a single-arm, multicenter study with 99 patients.
- LG-IR-NMIBC affects approximately 82,000 people in the U.S. annually.
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