UroGen Pharma announced positive results from a new analysis of the Phase 3 ATLAS trial, evaluating the durability of response of UGN-102 in patients with new and recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The data, presented at the American Urological Association (AUA) 2024 meeting, highlight the potential of UGN-102 as a non-surgical primary treatment option for this patient population.
The ATLAS trial randomized 282 patients with LG-IR-NMIBC to either UGN-102 with or without transurethral resection of the bladder tumor (TURBT) or TURBT alone. The new analysis focused on duration of response (DOR) and disease-free survival (DFS) specifically within the UGN-102 treatment arm, differentiating between new and recurrent cases.
Key Findings from the ATLAS Trial
The Kaplan-Meier analysis revealed that at 12 months after achieving a complete response (CR) at 3 months, the DOR was 87.5% in new patients and 69.1% in recurrent patients treated with UGN-102. Furthermore, the probability of DFS at 15 months from randomization was 77.4% in new patients and 63.2% in recurrent patients in the UGN-102 arm.
"These compelling findings shed light on the potential of UGN-102 as a nonsurgical primary treatment for low-grade intermediate-risk bladder cancer," said William Huang, M.D., Urologic Oncologist, Professor and Vice Chair of Urology, NYU Grossman School of Medicine. "These data are an encouraging step forward in addressing the broad spectrum of LG-IR-NMIBC and potentially curbing the high rates of disease recurrence associated with it."
UGN-102: A Novel Approach to Bladder Cancer Treatment
UGN-102 is a formulation of mitomycin utilizing UroGen’s RTGel technology, designed for sustained release within the bladder. Administered via a standard urinary catheter in an outpatient setting, UGN-102 aims to provide a non-surgical alternative for treating LG-IR-NMIBC, potentially reducing the need for repetitive TURBT procedures.
The Burden of LG-IR-NMIBC
In the United States, bladder cancer is the second most common urologic cancer in men. LG-IR-NMIBC accounts for approximately 22,000 new diagnoses and 60,000 recurrences annually. Current guidelines recommend TURBT as the standard of care, but recurrence rates are high, with up to 70% of patients experiencing at least one recurrence. This highlights the need for alternative treatment options that can improve patient outcomes and reduce the burden of repeated surgeries.
Ongoing Development and Regulatory Pathway
UroGen anticipates completing its New Drug Application (NDA) submission for UGN-102 in September 2024, with a potential FDA decision as early as the first quarter of 2025, contingent on positive data from the ongoing Phase 3 ENVISION trial. The ENVISION trial is evaluating UGN-102 as primary chemoablative therapy in patients with LG-IR-NMIBC, with the primary endpoint being the complete response rate at 3 months.
"Our aim is for UGN-102 to emerge as a non-surgical option for LG-IR-NMIBC, potentially sparing patients from the complexities and burdens associated with repetitive surgeries, including their inherent risks, side effects, and substantial impact on both individuals and healthcare systems," said Mark Schoenberg, M.D., Chief Medical Officer, UroGen.
