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UGN-102 Yields CRs in 4 out of 5 Patients With Intermediate-Risk NMIBC – Renal and Urology News

Chemoablation with UGN-102 produced a high complete response (CR) rate in patients with low-grade, intermediate-risk non-muscle-invasive bladder cancer (NMIBC) in the phase 3 ENVISION trial.

“Essentially, 4 out of 5 patients” experienced a CR, said study presenter Sandip Prasad, MD, of Morristown Medical Center in New Jersey. He described the results as “very robust.”

Dr Prasad presented results from the ENVISION trial (CinicalTrials.gov Identifier: NCT05243550) at the Society of Urologic Oncology Annual Meeting 2023.

The trial was designed to evaluate UGN-102 as a primary nonsurgical treatment for NMIBC. UGN-102 is an intravesically-delivered, mitomycin-containing reverse thermal gel that stays in the tissue longer than a conventional preparation of mitomycin.


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ENVISION enrolled 240 patients with low-grade, intermediate-risk NMIBC. The patients had a median age of 70 (range, 30-92) years, 61.3% were men, and 98.6% were White. Nearly all patients (96.3%) had undergone prior transurethral resection of bladder tumor.

The patients received UGN-102 once a week for 6 weeks. After 3 months, patients who did not have a CR could receive standard care. Patients who experienced recurrence or progression on study were also offered standard care.

At 3 months, 79.2% of patients had a CR (190/240). Of the 50 patients who did not achieve a CR, 35 had residual disease, 6 progressed to high-grade disease, 4 had indeterminate results, and 5 had missing results.

Data on the duration of response will likely be available in 2024, Dr Prasad said.

The rate of treatment-emergent adverse events (TEAEs) was 52.9%. The most common TEAEs were dysuria (22.1%), hematuria (8.3%), pollakiuria (6.3%), urinary tract infection (5.8%), and fatigue (5.4%).  

TEAEs were typically mild (25.0%) or moderate (19.6%). However, patients did experience severe or medically significant TEAEs (6.7%), and 2 patients (0.8%) experienced life-threatening TEAEs (urethral stenosis and urinary retention). One patient each died of pneumonia and cardiac arrest, but these TEAEs were considered unrelated to study treatment.

“If approved, UGN-102 would become the first nonsurgical treatment option for patients with low-grade, intermediate-risk, non-muscle invasive bladder cancer,” Dr Prasad noted.

Disclosures: This trial was supported by UroGen Pharma Ltd. Dr Prasad disclosed affiliations with UroGen, Janssen, Merck, Oncotype, and Propella Therapeutics. Additional disclosures were not provided.

Reference

Prasad S, Mladenov B, Shishkov D, et al. Primary chemoablation with UGN-102 for recurrent low grade intermediate risk (LG IR) NMIBC: The ENVISION trial. Presented at SUO 2023. Nov. 28 – Dec. 1, 2023. Washington, DC.

This article originally appeared on Cancer Therapy Advisor