UGN-102 Delivers High 12-Month DOR in Non-Muscle Invasive Bladder Cancer

Bladder cancer, light micrograph, photo under microscope: ©Dr_Microbe - stock.adobe.com

The investigational drug UGN-102 (mitomycin) demonstrated a 12-month duration of response (DOR) of 82.3% (95% CI, 75.9%-87.1%) by Kaplan-Meier estimate (n = 108) at 3 months after the first instillation in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC), according to findings from the phase 3 ENVISION trial (NCT05243550).¹

"UGN-102 has demonstrated a strong clinical profile across multiple trials, with these latest results of 79.6% three-month complete response rate and 82.3% DOR at 12 months reinforcing its potential to be the first FDA-approved non-surgical option for treatment of LG-IR-NMIBC," said Liz Barrett, president and chief executive officer of UroGen, in a press release. "We estimate 82,000 patients suffer from this highly recurrent disease in the US each year and may benefit from an innovative approach to treating their disease."

The Kaplan-Meier estimate for DOR at 15 months (n = 43) and 18 months (n = 9) were both 80.9% (95% CI, 73.9%-86.2%).

The trial previously met its primary end point of complete response( CR) rate. Patients treated with UGN-102 had a 79.6% (95% CI, 73.9%-84.5%) CR rate at 3 months following the first instillation.

Regarding safety, the most common treatment-emergent adverse events (TEAEs) observed in the ENVISION trial were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention. These AEs were mostly mild to moderate, and the safety profile is in line with what has been reported in other studies.

The agent is also being investigated in the phase 3 ATLAS trial (NCT04688931). Findings from the prespecified subgroup analysis of ATLAS were presented at the 2024 American Urological Association Annual Meeting and demonstrated that patients with newly diagnosed disease who received UGN-102 with or without transurethral resection of bladder tumor (n = 85) achieved a 15-month disease-free survival (DFS) rate of 77.4%. Those with recurrent disease (n = 57) achieved a 15-month DFS rate of 63.2%. Additionally, patients who experienced a CR in the newly diagnosed (n = 50) and recurrent (n = 42) subgroups achieved a 12-month DOR rate of 87.5% and 69.1%, respectively.²

About the Phase 3 ENVISION Trial

The ENVISION trial is investigating UGN-102 in patients with low-grade intermediate-risk NMIBC. The study’s primary end point is CR rate, and secondary end points include DOR, durable CR rate, DFS, and incidence of TEAEs.³

In the single-arm study, patients receive 6 once-weekly intravesical instillations of UGN-102.

Patients are eligible for enrollment if they have histologically confirmed disease, negative voiding cytology for high-grade diseases, adequate organ and bone marrow function, and agree to effective contraception usage. Those who have received Bacillus Calmette-Guérin within 1 year, have a history of high-grade bladder cancer, a clinically significant urethral stricture, or concurrent upper tract urothelial carcinoma are not eligible for participation.

REFERENCES:

1. UroGen announces unprecedented 82.3% duration of response at 12 months in the ENVISION trial investigating UGN-102 as potentially the first FDA-approved non-surgical treatment for LG-IR-NMIBC. News release. UroGen. June 13, 2024. Accessed June 17, 2024. https://tinyurl.com/y5kxz2c6

2. Prasad SM, Huang WC, Shore ND, et al. Response to primary chemoablation with UGN-102 in patients with new or recurrent LG IR NMIBC: post-hoc analysis of the ATLAS trial. J Urol. Published online May 1, 2024. doi:10.1097/01.JU.0001008848.77629.6f.09

3. A phase 3 single-arm study of UGN-102 for treatment of low grade intermediate risk non-muscle-invasive bladder cancer (ENVISION). ClinicalTrials.gov. Updated September 29, 2023. Accessed June 17, 2024. https://clinicaltrials.gov/study/NCT05243550