UroGen Reports Strong UGN-102 Results for Low-Grade Bladder Cancer at AUA 2024

PRINCETON, N.J-- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company aimed at developing and commercializing innovative treatments for urothelial and specialty cancers, has revealed promising results from a recent analysis of the ATLAS trial. This trial utilizes Kaplan Meier methods to estimate the probabilities of remaining in complete response for both new and recurrent patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) treated with the investigational drug UGN-102, either as primary therapy or in conjunction with transurethral resection of the bladder tumor (TURBT) at the three-month evaluation point.

Dr. William Huang, a Urologic Oncologist and Professor at NYU Grossman School of Medicine, expressed optimism about the findings, emphasizing that UGN-102 shows significant potential as a nonsurgical primary treatment for LG-IR-NMIBC. According to Dr. Huang, these data provide a promising outlook for managing the broad spectrum of LG-IR-NMIBC and potentially reducing high recurrence rates.

The Phase 3 ATLAS study involved 282 patients with either new or recurrent LG-IR-NMIBC, who were randomized to receive either UGN-102 ± TURBT or TURBT alone. The results indicated that Disease Free Survival (DFS) and DOR were better in patients treated with UGN-102 ± TURBT compared to those who underwent TURBT alone. Complete response (CR) rates at the three-month assessment were similar for both treatment groups. The analysis showed that at 12 months after achieving CR at three months, DOR was 87.5% in new patients and 69.1% in recurrent patients. Additionally, the probabilities of DFS rates at 15 months from randomization were 77.4% for new patients and 63.2% for recurrent patients treated with UGN-102.

Dr. Mark Schoenberg, Chief Medical Officer at UroGen, highlighted the potential impact of UGN-102 on the treatment landscape for LG-IR-NMIBC. He pointed out that UGN-102 could offer a non-surgical alternative, potentially sparing patients from the complications and burdens associated with repetitive surgeries.

The ATLAS trial's topline data and the Phase 3 ENVISION trial results were initially disclosed in July 2023. The 12-month DOR data from the pivotal Phase 3 ENVISION trial are expected by June 2024.

UGN-102, a mitomycin formulation for intravesical solution, is in Phase 3 development for treating LG-IR-NMIBC. The drug uses UroGen's proprietary RTGel® technology, a sustained-release, hydrogel-based formulation designed to enhance bladder tissue exposure to mitomycin, thus facilitating non-surgical tumor treatment. UGN-102 is administered via a standard urinary catheter in an outpatient setting. If the durability of response endpoint from the ENVISION Phase 3 study yields positive results, UroGen plans to submit a New Drug Application (NDA) for UGN-102 in September 2024, with a potential FDA decision as early as the first quarter of 2025.

Bladder cancer is the second most common urologic cancer in men in the U.S., with LG-IR-NMIBC accounting for approximately 22,000 new diagnoses annually and about 60,000 recurrences each year. TURBT is the standard of care for managing NMIBC, but up to 70 percent of patients experience recurrence, necessitating repeated procedures.

The ATLAS trial was a global, open-label, randomized controlled Phase 3 trial assessing the efficacy and safety of UGN-102 ± TURBT versus TURBT alone in LG-IR-NMIBC patients. The trial included 282 patients from clinical sites in the U.S., Europe, and Israel, who were randomized to receive either UGN-102 or TURBT. Patients in the UGN-102 arm received six weekly intravesical instillations. The primary endpoint of the study was disease-free survival.

The Phase 3 ENVISION trial, a single-arm, multinational, multicenter study, is evaluating the efficacy and safety of UGN-102 as primary chemoablative therapy in LG-IR-NMIBC patients. This trial enrolled approximately 240 patients across 56 sites, with participants receiving six once-weekly intravesical instillations of UGN-102. The primary endpoint assesses the CR rate at three months, with a key secondary endpoint evaluating durability over time. UroGen anticipates submitting an NDA for UGN-102 in September 2024, pending positive findings.

UroGen Pharma Ltd. is a biotech company focused on developing innovative urothelial and specialty cancer treatments. The company's RTGel reverse-thermal hydrogel technology aims to improve the therapeutic profiles of existing drugs by enabling prolonged exposure of urinary tract tissue to medications, potentially making local therapy more effective.

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