|The following article features coverage from the American Urological Association (AUA) 2019 meeting. Click here to read more of Renal & Urology News’ conference coverage.|
CHICAGO—Chemoablation of low-grade upper tract urothelial carcinoma (UTUC) with an investigational mitomycin gel formulation may obviate the need for nephrectomy in some patients, according to a secondary analysis from the pivotal phase 3 OLYMPUS trial presented at the 2019 American Urological Association annual meeting.
Among 71 patients with biopsy-proven low-grade UTUC treated with the mitomycin gel (UGN-101), 42 (59%) achieved a complete response (CR), the trial’s primary end point. In a subgroup of 34 patients who had endoscopically unresectable UTUC, 20 (59%) experienced CR.
Twenty-seven of the 41 patients who entered follow-up have had a 6-month evaluation. Of these, 24 (89%) remained free of disease.
The initial high rate of disease eradication in nearly half of the patients obviates the need for a nephroureterectomy after 6 weeks of treatment, said investigator Seth Lerner, MD, of Baylor College of Medicine in Houston, who presented study findings during an oral session.
If the FDA approves the drug, UGN-101 “may provide an alternative treatment for patients with low-grade upper urinary tract disease confined to the renal pelvis,” Dr Lerner told attendees.
UGN-101 would be the first drug approved for the non-surgical treatment of low-grade UTUC, according to a press release from New York-based UroGen Pharma, Ltd, which is developing the medication and is funding the ongoing study.
Study patients received 6 weekly instillations of the gel via retrograde catheter to the renal pelvis and calyces. At the time of treatment initiation, all patients had measurable tumor (minimum lesion size greater than 0.5 cm). From 4 to 6 weeks after the final instillation, all patients underwent a primary disease evaluation, including ureteroscopy and wash cytology.
The most common adverse events observed were urinary tract infection, ureteral narrowing, and structural formation.
Read more of Renal & Urology News’ coverage of the AUA 2019 meeting by visiting the conference page.
Kleinmann N, Gan R, Matin S, et al. Nephron-sparing management of low grade (LG) UTUC with UGN-101 (mitomycin gel) for instillation: The Olympus Trial experience. Presented at the 2019 American Urological Association annual meeting held May 3-6 in Chicago. Abstract LBA-16.