UGN-102 demonstrates long-term durability in NMIBC

Updated data from the phase 3 ENVISION trial (NCT05243550) show a 12-month duration of response (DOR) of 82.3% (95% CI, 75.9%–87.1%) among patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer (LG-IR-NMIBC) who achieved a complete response at 3 months following the first instillation of UGN-102 (mitomycin) for intravesical solution, UroGen announced in a news release.¹

“These DOR findings continue to support the development of UGN-102 as a non-surgical alternative to the current standard of care of repeated surgeries for LG-IR-NMIBC, which can impact patients’ physical health and quality of life,” says Sandip Prasad, MD, MPhil.

The study also reported a DOR of 80.9% (95% CI, 73.9%–86.2%) at both 15 (n = 43) and 18 (n = 9) months, per Kaplan-Meier estimates.

These findings come after previously reported data showing that the ENVISION trial met its primary end point with 79.6% of patients treated with UGN-102 achieving a complete response at 3 months following the first instillation of the therapy.²

“UGN-102 has demonstrated a strong clinical profile across multiple trials, with these latest results of 79.6% 3-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 the news release.¹ “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.”

Regarding safety, the most common treatment-emergent adverse events (TEAEs) reported in the trial includeddysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention. According to UroGen, TEAEs were generally mild to moderate in severity.

Overall, the single-arm, multinational, multicenter, ENVISION trial is evaluating the safety and efficacy of UGN-102 as a primary chemoablative therapy in patients with LG-IR-NMIBC.In total, the study enrolled approximately 240 patients across 56 sites. Those included in the study received 6 once-weekly intravesical instillations of UGN-102.

The primary end point for the trial is the complete response rate at 3 months. Secondary outcome measures include DOR, durable complete response rate, disease-free survival (DFS), and safety outcomes.³

In January 2024, a rolling new drug application (NDA) was submitted to the FDA for potential approval of UGN-102 for patients with LG-IR-NMIBC. With the addition of the updated ENVISION data, UroGen plans to complete the NDA in Q3 of 2024, which would enable an FDA decision by as early as Q1 in 2025.

“These DOR findings continue to support the development of UGN-102 as a non-surgical alternative to the current standard of care of repeated surgeries for LG-IR-NMIBC, which can impact patients’ physical health and quality of life,” said Sandip Prasad, MD, MPhil, Director of Genitourinary Surgical Oncology at Morristown Medical Center/Atlantic Health System, NJ, in the news release.1 “These results from the ENVISION study make me very optimistic about the opportunity for UGN-102, if approved, to provide another option for patients living with this highly recurrent disease.”

Additional data on UGN-102

In addition to the phase 3 ENVISION trial, UGN-102 is also being evaluated in the phase 3 ATLAS trial. In ATLAS, patients with LG-IR-NMIBC were randomly assigned to receive UGN-102 with or without transurethral resection of the bladder tumor (TURBT) or to TURBT alone.

In July 2023, it was reported that the ATLAS trial met its primary end point of DFS, with UGN-102 demonstrating a 55% reduction in the rate of recurrence, progression, or death vs TURBT.² Additional data showed a complete response rate of 64.8% at 3 months among those who received only UGN-102, compared with 63.6% among those who received only a TURBT.

Additional data from the phase 3 ATLAS trial were presented earlier this year at the 2024 American Urological Association Annual Meeting in San Antonio, Texas.⁴ These data specifically assessed DFS and DOR rates among new and recurrent patients receiving UGN-102 with or without TURBT. Overall, 12-month Kaplan-Meier estimates showed a DOR of 87.5% among new patients and 69.1% among recurrent patients. Additionally, 15-month DFS estimates were 77.4% among new patients and 63.2% among recurrent patients.

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. Published online and accessed June 13, 2024. https://investors.urogen.com/news-releases/news-release-details/urogen-announces-unprecedented-823-duration-response-12-months

2. UGN-102, in development as the potential first non-surgical therapy for LG-IR-NMIBC, met primary endpoints in both phase 3 ATLAS and ENVISION clinical trials. News release. UroGen. July 27, 2023. Accessed June 13, 2024. https://investors.urogen.com/news-releases/news-release-details/ugn-102-development-potential-first-non-surgical-therapy-lg-ir

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. Last updated September 29, 2023. Accessed June 13, 2024. https://clinicaltrials.gov/study/NCT05243550

4. UroGen announces results from ATLAS showing robust UGN-102 durability of response in new and recurrent low-grade intermediate-risk non-muscle invasive bladder cancer at AUA 2024. News release. May 4, 2024. Accessed June 13, 2024. https://investors.urogen.com/news-releases/news-release-details/urogen-announces-results-atlas-showing-robust-ugn-102-durability