UGN-102 - Top line Phase 3 study results - Mark Schoenberg, MD

Mark Schoenberg, MD has unveiled groundbreaking results from its Phase 3 clinical trials, ATLAS and ENVISION, for UGN-102, a non-surgical treatment option targeting low-grade, intermediate-risk non-muscle invasive bladder cancer.


Mark Schoenberg, MD- UrologyGenitourinary (GU) CancerBladder Cancer-The Montefiore Medical Center and The Albert Einstein College of Medicine at UroGen Pharma

What is UGN-102, and what is its potential role as the first non-surgical therapy for LG-IR-NMIBC?

Could you explain the primary endpoints achieved in both the ATLAS and ENVISION clinical trials for UGN-102?

In the ATLAS trial, UGN-102 showed a 55% reduction in the risk of recurrence, progression, or death compared to TURBT. How significant is this finding for patients with LG-IR-NMIBC?

What was the complete response rate at three months observed in the ENVISION trial, and how does it compare to other treatments for LG-IR-NMIBC?

The side effect profile of UGN-102 in the ATLAS and ENVISION trials was consistent with previous clinical trials. Could you elaborate on the common side effects observed?

How does UGN-102 work as a sustained release, hydrogel-based formulation, and how does it enable longer exposure of bladder tissue to mitomycin?

Considering the positive data from the trials, how does UGN-102 differ from the standard treatment of TURBT, and what benefits does it offer to patients with LG-IR-NMIBC?

UroGen Pharma plans to submit a New Drug Application (NDA) for UGN-102 in 2024, assuming additional positive findings. What are the anticipated milestones for the drug's approval process?

For patients with LG-IR-NMIBC who currently undergo multiple surgeries, how might UGN-102, if approved, change the treatment paradigm and improve their outcomes?

Could you provide more details about the upcoming data event and panel discussion with bladder cancer experts? How can physicians participate and learn more about the results of the ATLAS and ENVISION trials?

UroGen Pharma Ltd. has announced promising results from its Phase 3 clinical trials, ATLAS and ENVISION, evaluating UGN-102, a potential non-surgical therapy for patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). In the ATLAS trial, UGN-102 demonstrated its superiority over the standard surgical treatment, TURBT, by reducing the risk of recurrence, progression, or death by 55%. The ENVISION trial showcased an impressive complete response rate of 79.2% at three months following the initial treatment. These results suggest that UGN-102 could be a game-changer in the field of bladder cancer treatment, offering a minimally invasive alternative to repetitive surgeries for this recurrent disease, which affects a substantial number of patients each year. UroGen plans to submit a New Drug Application (NDA) for UGN-102 in 2024, pending further positive findings.

UGN-102 is a sustained-release, hydrogel-based formulation designed to deliver mitomycin directly to bladder tissue, offering longer exposure to the drug without surgery. The positive outcomes in both trials align with UroGen's vision to transform the standard of care for LG-IR-NMIBC by providing a non-surgical treatment option. This development holds the potential to significantly impact the lives of patients, reducing the need for multiple surgeries and their associated risks. UroGen will continue to explore the potential of UGN-102 and aims to provide a novel therapeutic approach for this challenging and recurrent form of bladder cancer.