The phase 1 study is intended to characterize the safety, tolerability, and feasibility of intravesical administration of UGN-501.
|Videos|August 24, 2022
Sequential intravesical gemcitabine and docetaxel effective in BCG-naïve NMIBC
Author(s)Urology Times staff
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Vignesh Packiam, MD, discusses the results of the study, “Sequential Intravesical Gemcitabine and Docetaxel for bacillus Calmette-Guérin-Naïve High-Risk Nonmuscle-Invasive Bladder Cancer,” which was published in the Journal of Urology. Packiam is a clinical assistant professor of Urology, Department of Urology, University of Iowa Hospitals and Clinics.
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Paras H. Shah, MD, recaps data on emerging agents in high-risk NMIBC from the 2026 AUA North Central Section Meeting.
Five-year follow-up data show durable responses with UGN-101 in patients with low-grade upper tract urothelial carcinoma who achieved an initial complete response.
Topline results are expected in November 2026 ahead of a planned sBLA submission.
In a POTOMAC subgroup analysis, durvalumab plus BCG reduced the risk of high-risk recurrence or death by 44% vs BCG alone in patients with papillary-only, BCG-naive NMIBC.
Andrea Necchi, MD, discusses how results from the CA017-078 trials compares with other perioperative immunotherapy trials in muscle-invasive bladder cancer.
Final phase 3 CA017-078 data show perioperative nivolumab plus GC did not significantly improve pCR (39.1% vs 29.6%) or EFS (HR, 0.94) vs GC alone in MIBC.
Perioperative durvalumab (Imfinzi) plus neoadjuvant enfortumab vedotin-ejfv (Padcev) cut the risk of EFS events by 49% and death by 42% in cisplatin-ineligible MIBC.
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