Durability of Response to Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma Using UGN-101, a Mitomycin-Containing Reverse Thermal Gel: OLYMPUS Trial Final Report

Surena F. Matin; Phillip M. Pierorazio; Nir Kleinmann; John L. Gore; Ahmad Shabsigh; Brian Hu; Karim Chamie; Guilherme Godoy; Scott G. Hubosky; Marcelino Rivera; Michael O'Donnell; Marcus Quek; Jay D. Raman; John J. Knoedler; Douglas Scherr; Christopher Weight; Alon Weizer; Michael Woods; Hristos Kaimakliotis; Angela B. Smith; Jennifer Linehan; Jonathan Coleman; Mitchell R. Humphreys; Raymond Pak; David Lifshitz; Michael Verni; Ifat Klein; Marina Konorty; Dalit Strauss-Ayali; Gil Hakim; Elyse Seltzer; Mark Schoenberg; Seth P. Lerner

doi:10.1097/JU.0000000000002350

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Durability of Response to Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma Using UGN-101, a Mitomycin-Containing Reverse Thermal Gel: OLYMPUS Trial Final Report

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Durability of Response to Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma Using UGN-101, a Mitomycin-Containing Reverse Thermal Gel: OLYMPUS Trial Final Report

Surena F. Matin, Phillip M. Pierorazio, Nir Kleinmann, John L. Gore, Ahmad Shabsigh, Brian Hu, Karim Chamie, Guilherme Godoy, Scott G. Hubosky, Marcelino Rivera, …

The Journal of urology, Vol.207(4), pp.779-788

04/01/2022

DOI: 10.1097/JU.0000000000002350

PMID: 34915741

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Abstract

Purpose: Our goal was to evaluate long-term safety and durability of response to UGN-101, a mitomycin-containing reverse thermal gel, as primary chemoablative treatment for low-grade upper tract urothelial carcinoma. Materials and Methods: In this open-label, single-arm, multicenter, phase 3 trial (NCT02793128), patients >= 18 years of age with primary or recurrent biopsy-proven low-grade upper tract urothelial carcinoma received 6 once-weekly instillations of UGN-101 via retrograde catheter to the renal pelvis and calyces. Those with complete response (defined as negative ureteroscopic evaluation, negative cytology and negative for-cause biopsy) 4-6 weeks after the last instillation were eligible for up to 11 monthly maintenance instillations and were followed for >= 12 months with quarterly evaluation of response durability. Durability of complete response was determined by ureteroscopic evaluation; duration of response was estimated by the Kaplan-Meier method. Treatment-emergent adverse events (TEAEs) were monitored. Results: Of 71 patients who initiated treatment, 41 (58%) had complete response to induction therapy and consented to long-term followup; 23/41 patients (56%) remained in complete response after 12 months (95% CI 40, 72), comprising 6/12 (50%) who did not receive any maintenance instillations and 17/29 (59%) who received >= 1 maintenance instillation. Kaplan-Meier analysis of durability was estimated as 82% (95% CI 66, 91) at 12 months. Ureteric stenosis was the most frequently reported TEAE (31/71, 44%); an increasing number of instillations appeared to be associated with increased incidence of urinary TEAEs. Conclusions: Durability of response to UGN-101 with or without maintenance treatment is clinically meaningful, offering a kidney-sparing therapeutic alternative for patients with low-grade disease.

Life Sciences & Biomedicine

Science & Technology

Urology & Nephrology

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Title: Subtitle: Durability of Response to Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma Using UGN-101, a Mitomycin-Containing Reverse Thermal Gel: OLYMPUS Trial Final Report
Creators: Surena F. Matin - The University of Texas MD Anderson Cancer Center
Phillip M. Pierorazio - Johns Hopkins University
Nir Kleinmann - Sheba Medical Center
John L. Gore - University of Washington Medical Center
Ahmad Shabsigh - The Ohio State University
Brian Hu - Loma Linda University
Karim Chamie - University of California, Los Angeles
Guilherme Godoy - Baylor College of Medicine
Scott G. Hubosky - Thomas Jefferson University
Marcelino Rivera - Mayo Clinic Health System
Michael O'Donnell - Univ Iowa, Dept Urol, Iowa City, IA 52242 USA
Marcus Quek - Loyola University Medical Center
Jay D. Raman - Penn State Milton S. Hershey Medical Center
John J. Knoedler - Penn State Milton S. Hershey Medical Center
Douglas Scherr - Cornell University
Christopher Weight - Cleveland Clinic
Alon Weizer - University of Michigan
Michael Woods - Loyola University Medical Center
Hristos Kaimakliotis - Indiana University
Angela B. Smith - University of North Carolina at Chapel Hill
Jennifer Linehan - Saint John's Health Center
Jonathan Coleman - Memorial Sloan Kettering Cancer Center
Mitchell R. Humphreys - Department of Urology, Mayo Clinic-Phoenix, Scottsdale, AZ
Raymond Pak - Mayo Clinic in Florida
David Lifshitz - Rabin Medical Center
Michael Verni - Urology Center of Las Vegas, Las Vegas, NV
Ifat Klein - UroGen Pharma, Ra’anana, Israel
Marina Konorty - UroGen Pharma, Ra’anana, Israel
Dalit Strauss-Ayali - UroGen Pharma, Ra’anana, Israel
Gil Hakim - UroGen Pharma, Raanana, Israel
Elyse Seltzer - UroGen Pharma, Princeton, NJ
Mark Schoenberg - UroGen Pharma, Princeton, NJ
Seth P. Lerner - Baylor College of Medicine
Resource Type: Journal article
Publication Details: The Journal of urology, Vol.207(4), pp.779-788
DOI: 10.1097/JU.0000000000002350
PMID: 34915741
NLM abbreviation: J Urol
ISSN: 0022-5347
eISSN: 1527-3792
Publisher: Lippincott Williams & Wilkins
Number of pages: 10
Grant note: UroGen Pharma
Language: English
Date published: 04/01/2022
Academic Unit: Urology
Record Identifier: 9984319983802771

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