UGN-102 is a reverse thermo-gelation hydrogel containing mitomycin. It is in liquid form at low temperatures and solid form in body temperature.
In this presentation, William Huang, MD, presented the OPTIMA II (NCT03558503) study: assessing the efficacy and safety of UGN-102 as primary chemo-ablative therapy in patients with low grade non-muscle invasive bladder cancer at intermediate risk of recurrence (Figure 1). The objective of this study was to evaluate the efficacy and safety of UGN-102 for non-surgical chemo ablation in patients with low-grade intermediate risk non-muscle invasive bladder cancer. This was a prospective single-arm, open-label phase 2B clinical trial.
Figure 1 – OPTIMA II study design:
The inclusion and exclusion criteria are shown in Table 1.
Table 1 – Inclusion and exclusion criteria:
The primary endpoint of the study was a complete response rate at the three-month visit. Secondary endpoints included durability of complete response rate at 6, 9, and 12 months visit. Safety was another secondary endpoint.
Patient demographics are shown in Table 2.
Table 2: Patient demographics:
The study demonstrated a complete response rate of 65% (95% CI 52-77%) at three months follow-up. The interim durability of complete response is shown in Table 3, and the adverse effects are shown in Table 4.
Table 3 – Interim durability of complete response:
Table 4 – Adverse events:
Dr. Huang concluded his talk stating that UGN-102 chemoablation results in 65% complete response rate at three months with interim durability of complete response rate at:
- 6 months after enrollment of 97.2%
- 9 months after enrollment of 85.7%
- 12 months after enrollment of 84.6%
The most commonly reported adverse events were dysuria, urinary frequency, hematuria, fatigue, urinary urgency, urinary tract infection, pruritus in the genital area, and vulvovaginal discomfort.
These interim data demonstrate that primary chemoablation of low-grade intermediate risk non-muscle invasive bladder cancer with UGN-102 results in significant treatment response and encouraging durability. According to Dr. Huang, this novel treatment may provide an alternative to TURBT procedure for patients with low-grade intermediate risk non-muscle invasive bladder cancer.
Presented by: William Huang, MD, Chief of Urology, Tisch Hosptial, NYU Langone Medical Center, New York, NY, USAWritten by: Hanan Goldberg, MD, MSc., Urology Department, SUNY Upstate Medical University, Syracuse, NY, USA, Twitter: @GoldbergHanan, at the 2020 American Urological Association (AUA) Annual Meeting, Virtual Experience #AUA20, June 27- 28, 2020.
Read: UroGen Pharma Announces First Presentation of Data from Phase 2b Study of UGN-102 in Patients with Difficult to Treat Type of Bladder Cancer
Read: UroGen Announces Positive Interim Data from Phase 2b Study of UGN-102 in Patients with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer