A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Summary

This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Timeline

Start

2021-02-19

Primary completion

2023-03-17

Completion

2023-03-17

Publications

• Results Prasad SM, Huang WC, Shore ND, Hu B, Bjurlin M, Brown G, Genov P, Shishkov D, Khuskivadze A, Ganev T, Marchev D, Orlov I, Kopyltsov E, Zubarev V, Nosov A, Komlev D, Burger B, Raju S, Meads A, Schoenberg M. Treatment of Low-grade Intermediate-risk Nonmuscle-invasive Bladder Cancer With UGN-102 +/- Transurethral Resection of Bladder Tumor Compared to Transurethral Resection of Bladder Tumor Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS). J Urol. 2023 Oct;210(4):619-629. doi: 10.1097/JU.0000000000003645. Epub 2023 Aug 7.

Drugs

Indications