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Duration of response (DoR) following treatment with UGN-102 in patients with recurrent, low-grade, intermediate-risk, non-muscle invasive, bladder cancer: 18-month DoR data from the phase 3 ENVISION trial
Sandip M. Prasad, MD, MPhil
1, Dimitar Shishkov, MD
2, Nikola V. Mihaylov, MD
2, Alexandre Khuskivadze, MD
3, Pencho Genov, MD, PhD
4, Vasyl Terzi, MD
5, Max Kates, MD
6,
William C. Huang, MD7, Michael J. Louie, MD
8, Sunil Raju, MBBS
8, Brent Burger, MSc, MBA
8, Andrew Meads, BS
8, Mark Schoenberg, MD
9.
1Morristown Medical Center/Atlantic Health System and Garden State Urology, Morristown, NJ, USA,
2University Multiprofile Hospital for Active Treatment, Plovdiv, Bulgaria,
3Georgia Israel Joint Clinic Gidmedi, Tbilisi, Georgia,
4University Multiprofile Hospital for Active Treatment Kanev, Ruse, Bulgaria,
5Multiprofile Hospital for Active Treatment Varna, Military Medical Academy, Varna, Bulgaria,
6Johns Hopkins Medicine, Baltimore, MD, USA,
7NYU Langone Urology Associates, New York, NY, USA,
8UroGen Pharma, Princeton, NJ, USA,
9UroGen Pharma, Princeton, NJ, USA; and The Department of Urology, Montefiore Medical Center: Einstein Campus, Bronx, NY, USA.
BACKGROUND: Low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) is a recurrent cancer inadequately controlled by current standard of care: transurethral resection of bladder tumor (TURBT). ENVISION (NCT05243550) is an ongoing prospective, phase 3, multinational, single-arm trial evaluating UGN-102, a reverse thermal hydrogel containing mitomycin (75 mg), in patients with a history of LG-NMIBC requiring TURBT. Primary efficacy and safety results have been published previously; long-term durability data (18 months after complete response [CR]) are reported here.
METHODS: Patients received 6 weekly intravesical instillations of UGN-102. Approximately 3 months after the first instillation, patients underwent cystoscopy, urine-cytology testing, and for-cause biopsy to determine bladder cancer presence. Duration of response (DoR; time from CR at 3 months to the earliest date of disease recurrence, progression, or death from any cause, whichever occurred first) at 18 months was calculated using Kaplan-Meier (KM) estimate with Brookmeyer-Crowley confidence intervals (CI).
RESULTS: 240 patients with recurrent LG-IR-NMIBC were enrolled and received ≥1 dose of UGN-102; 95% (228) received all 6 doses. Patients were mainly white (98%), male (61%), and aged ≥65 years (68%). CR at 3 months was achieved by 191 patients (79.6%; 95% CI: 73.9, 84.5). For these patients, the probability of remaining in response 18-months after CR was 80.6% (95% CI: 74.0, 85.7; KM estimate). Of those who experienced recurrence post CR, most experienced LG disease (17.3%).
CONCLUSIONS: UGN-102 treatment in patients with recurrent LG-IR-NMIBC resulted in a high and clinically meaningful CR rate. Patients who achieved an initial CR at 3 months had a high probability of remaining disease-free 18 months later. These data indicate that UGN-102 provides a long recurrence-free interval for patients with LG-IR-NMIBC.
*3-month CR patients only, estimated using reverse KM; **Includes high-grade disease, T1, and Cis. | | | UGN-102 |
| CR at 3 months (95% CI) | | 191/240, 79.6% (73.9, 84.5) |
| Median follow-up time for DoR, months (95% CI)* | | 18.73 (18.23, 20.27) |
| DoR by KM estimate at 18 months post CR | | 80.6% (95% CI: 74.0, 85.7) |
| Patients with events at 18 months post CR | | 39/191 (20.4%) |
| LG disease | | 33/191 (17.3%) |
| Progression** | | 4/191 (2.1%) |
| Death | | 2/191 (1.0%) |
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