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SAFETY PROFILE OF UGN-102 IN THE TREATMENT OF ADULT PATIENTS WITH RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE BLADDER CANCER
Sandip M. Prasad, MD1, Neal D. Shore, MD2, Brian Hu, MD3, William C. Huang, MD4, Michael J. Louie, MD, MPH, MSC5, Nikky Ugwuoke, PharmD, MPH5, Victoria Tsurutis, PharmD, BCPS, BCMAS5, Brent Burger, MSc, MBA5, Mark Schoenberg, MD6.
1Morristown Medical Center/Atlantic Health System and Garden State Urology, Morristown, NJ, USA, 2Carolina Urologic Research Center, Myrtle Beach, SC, USA, 3Loma Linda University, Loma Linda, CA, USA, 4NYU Langone Urology Associates, New York, NY, USA, 5UroGen Pharma, Princeton, NJ, USA, 6UroGen Pharma, Princeton, NJ, USA, and The Department of Urology, Montefiore Einstein, Bronx, NY, USA.
BACKGROUND: UGN-102 (mitomycin 75 mg in reverse thermal hydrogel) is an FDA-approved intravesical treatment for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Intravesical chemotherapies can be associated with adverse reactions including allergic skin reactions, cystitis, dysuria, and laboratory abnormalities. This is a pooled, post hoc safety review of UGN-102 across clinical studies in patients with recurrent LG-IR-NMIBC.
METHODS: Patients received 6 once-weekly outpatient intravesical instillations of UGN-102 in single-arm late-phase studies, OPTIMA II (NCT03558503), Home instillation (NCT05136898), and ENVISION (NCT05243550). In the randomized, controlled Phase 3 ATLAS trial (NCT04688931), patients received 6 once-weekly instillations of UGN-102 or transurethral resection of bladder tumor; only UGN-102-treated patients are included in this analysis. Data from patients with prior NMIBC were pooled and treatment-emergent adverse events (TEAEs) occurring within 3 months after start of treatment were summarized.
RESULTS: 346 UGN-102-treated patients with prior NMIBC were included in this analysis. Patients had a mean age of 68.9 years, 63.3% were male, and 96.2% were White. 323 (93.4%) patients received all 6 UGN-102 instillations; 23 (6.6%) received <6 instillations. Within the first 3 months of treatment, 206 (59.5%) patients experienced a TEAE (Table). Serious adverse events occurred in 20 (5.8%) patients. Grade 3 or higher TEAEs occurred in 22 (6.4%) patients; treatment-related TEAEs occurred in 135 (39.0%) patients. The most frequent TEAEs were dysuria (96 [27.7%] patients) and pollakiuria (33 [9.5%] patients). Cystitis, hypersensitivity, and urinary tract infections were each reported in 3 patients, and dystrophic calcification, leukopenia, and thrombocytopenia were each reported once.
CONCLUSIONS: UGN-102, a primary nonsurgical treatment for recurrent LG-IR-NMIBC, demonstrates a safety profile that can be managed in routine urologic practice.
FUNDING: UroGen Pharma
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