UroGen - Model UGN-102 - Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancers are described as muscle invasive or non-muscle invasive (NMIBC) based on whether they have invaded into the wall of the bladder. Of the approximately 60,000 newly diagnosed cases of NMIBC per year, nearly 60% are considered low grade (LG). While there is a low risk of progression and mortality in this population, chronically relapsing disease remains a pervasive problem. In patients who recur, it is estimated that 68% will experience 2 or more recurrence episodes throughout the course of their disease.

The current primary standard of care for treating LG NMIBC patients is a surgical procedure known as transurethral resection of bladder tumor (TURBT). Repeated TURBT procedures can impact patients’ physical health and quality of life and are even associated with an increased risk in mortality. Due to the high disease recurrence rates, patients may need multiple TURBTs over the course of their lifetime, leaving them more prone to these surgical burdens.

There are currently no drugs approved by the US FDA for primary treatment of NMIBC—the 3 drugs currently approved are all indicated as adjuvant therapies. Without a definitive alternative, TURBT remains the only first-line option for patients.

UroGen conducted a readout of a phase 2b study to further investigate UGN-102 for the treatment of intermediate-risk LG NMIBC. Currently UGN-102 is in Phase 3.