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Clinical Trial
. 2022 Jan;207(1):61-69.
doi: 10.1097/JU.0000000000002186. Epub 2021 Aug 26.

Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial

K Kent Chevli  1 , Neal D Shore  2 , Andrew Trainer  3 , Angela B Smith  4 , Daniel Saltzstein  5 , Yaron Ehrlich  6 , Jay D Raman  7 , Boris Friedman  8 , Richard D'Anna  9 , David Morris  10 , Brian Hu  11 , Mark Tyson  12 , Alexander Sankin  13 , Max Kates  14 , Jennifer Linehan  15 , Douglas Scherr  16 , Steven Kester  17 , Michael Verni  18 , Karim Chamie  19 , Lawrence Karsh  20 , Arnold Cinman  21 , Andrew Meads  22 , Soumi Lahiri  22 , Madlen Malinowski  22 , Nimrod Gabai  22 , Sunil Raju  22 , Mark Schoenberg  13   22 , Elyse Seltzer  22 , William C Huang  23
Affiliations
Clinical Trial

Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial

K Kent Chevli et al. J Urol. 2022 Jan.

Abstract

Purpose: Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC) is a recurrent disease, thus requiring repeated transurethral resection of bladder tumor under general anesthesia. We evaluated the efficacy and safety of UGN-102, a mitomycin-containing reverse thermal gel, as a primary chemoablative therapeutic alternative to transurethral resection of bladder tumor for patients with LG IR NMIBC.

Materials and methods: This prospective, phase 2b, open-label, single-arm trial recruited patients with biopsy-proven LG IR NMIBC to receive 6 once-weekly instillations of UGN-102. The primary end point was complete response (CR) rate, defined as the proportion of patients with negative endoscopic examination, negative cytology and negative for-cause biopsy 3 months after treatment initiation. Patients with CR were followed quarterly up to 12 months to assess durability of treatment effect. Safety and adverse events were monitored throughout the trial.

Results: A total of 63 patients (38 males and 25 females 33-96 years old) enrolled and received ≥1 instillation of UGN-102. Among the patients 41 (65%) achieved CR at 3 months, of whom 39 (95%), 30 (73%) and 25 (61%) remained disease-free at 6, 9 and 12 months after treatment initiation, respectively. A total of 13 patients had documented recurrences. The probability of durable response 9 months after CR (12 months after treatment initiation) was estimated to be 73% by Kaplan-Meier analysis. Common adverse events (incidence ≥10%) included dysuria, urinary frequency, hematuria, micturition urgency, urinary tract infection and fatigue.

Conclusions: Nonsurgical primary chemoablation of LG IR NMIBC using UGN-102 resulted in significant treatment response with sustained durability. UGN-102 may provide an alternative to repetitive surgery for patients with LG IR NMIBC.

Trial registration: ClinicalTrials.gov NCT03558503.

Keywords: clinical trial; mitomycin; phase II; urinary bladder neoplasms.

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Conflict of interest statement

JL, DM, JDR and DSa report acting as investigators and consultants/advisors for UroGen Pharma; KC, BH, NDS and ABS report serving as consultants/advisors for UroGen Pharma; NG, SL, MM, AM, SR, MS and ES are full-time employees of UroGen Pharma; MT reports serving as an assistant editor for The Journal of Urology®; KKC, AC, RD’A, YE, BF, WCH, LK, MK, SK, AS, DSc, AT and MV report no direct or indirect commercial financial incentive associated with publishing the article.

Figures

Figure 1.
Figure 1.
Flow diagram.
Figure 2.
Figure 2.
Kaplan-Meier plot of duration of CR (3-month CR analysis set).
See this image and copyright information in PMC

Comment in

  • Editorial Comment.
    Chipollini J. Chipollini J. J Urol. 2022 Jan;207(1):69. doi: 10.1097/JU.0000000000002186.01. Epub 2021 Oct 18. J Urol. 2022. PMID: 34661456 No abstract available.
  • Editorial Comment.
    Croll B, Joshi SS. Croll B, et al. J Urol. 2022 Jan;207(1):69. doi: 10.1097/JU.0000000000002186.02. Epub 2021 Oct 18. J Urol. 2022. PMID: 34661457 No abstract available.

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