The treatment of low-grade upper tract urothelial carcinomas (UTUCs) after either surgery, or nephron-sparing techniques remains an unmet need in Genitourinary (GU) Oncology. UGN-101 is a novel drug in development for the treatment of UTUCs; it is composed of a sustained-release hydrogel polymer-based formulation containing the antitumor antibiotic mitomycin-C (MM-C); cold UGN-101 is liquid, but at body temperature, it becomes a gel, and thus, when administered through a ureteral catheter, it sticks to the upper tract urothelium, slowly releasing MM-C.
Here, the authors review the preclinical rationale for the development of UGN-101, as well as presently available clinical results for the treatment of low-grade UTUCs.
The positive results of the recently completed OLYMPUS trial suggest the feasibility, activity (59% of complete responses, with just 6 of these complete responders on follow-up who recurred), and safety (68% of patients experiencing mild to moderate urinary adverse events) of UGN-101 instillations into the upper urinary tract. Our expectations are that UGN-101 will soon become a standard of treatment for low-grade UTUC at risk of relapse after either surgery, or nephron-sparing techniques.
Expert opinion on pharmacotherapy. 2020 Sep 01 [Epub ahead of print]
Camillo Porta, Patrizia Giannatempo, Mimma Rizzo, Giuseppe Lucarelli, Pasquale Ditonno, Michele Battaglia
Department of Biomedical Sciences and Human Oncology, University of Bari 'A. Moro' , Bari, Italy., Department of Surgery, Unit of Surgical and Oncological Urology, IRCCS National Cancer Institute , Milan, Italy., Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri , Pavia, Italy., Department of Emergency and Organ Transplantation, Urology, Andrology, and Kidney Transplantation Unit, University of Bari 'A. Moro' , Bari, Italy., Department of Emergency and Organ Transplantation, Unit of Urology II, University of Bari 'A. Moro' , Bari, Italy.