UroGen Pharma Announces Positive Findings Presentation from a Secondary Analysis from Phase 3 OLYMPUS Trial of UGN-101 for Patients with Low-Grade Upper Tract Urothelial Cancer

San Francisco, CA (UroToday.com) – On Sunday, May 5, at the AUA 2019 UroGen Pharma Ltd. will announce positive findings from a secondary analysis from the pivotal Phase 3 OLYMPUS trial (abstract #19-9773).

Topline results released in January 2019 showed that on an intent-to-treat basis, 57% of patients achieved a complete response (CR) rate at their primary disease evaluation (PDE, or the primary endpoint) which was conducted four to six weeks after completion of UGN-101 treatment. Importantly, all evaluated patients in CR remain disease free at six months.

Seth Paul Lerner, M.D., FACS, Professor of Urology at Baylor College of Medicine, will present the new data during an oral presentation during the plenary session.

UGN-101 (mitomycin gel) for instillation is an investigational drug formulation of mitomycin in Phase 3 development as a kidney-sparing treatment option for low-grade upper tract urothelial cancer (LG UTUC).

Details of AUA Oral Presentation

Abstract #: LBA-16
Session: Plenary Session, Next Frontier
Title: Nephron-sparing Management of Low Grade (LG) UTUC With UGN-101 (mitomycin gel) for Instillation: The Olympus Trial Experience
Presenter: Seth Paul Lerner, M.D., FACS, Professor of Urology, Baylor College of Medicine
Date and Time: Sunday, May 5, 2019; 3:17 – 3:26 PM CDT
Location: MCP: W375d

Nephron-sparing management of Low Grade (LG) UTUC with UGN-101 (mitomycin gel) for instillation: The Olympus Trial Experience
Nir Kleinmann, Ramat Gan, Israel, Surena Matin, Houston, TX, Philip Pierorazio, Baltimore, MD, John Gore, Seattle, WA, Ahmad Shabsigh, Columbus, OH, Brian Hu, Loma Linda, CA, Karim Chamie, Los Angeles, CA, Guy Godoy, Houston, TX, Scott Hubosky, Philadelphia, PA, Marcelino RIvera, Rochester, MN, Michael O'Donnell, Iowa City, IA, Marcus Quek, Maywood, IL, Jay Raman, Hershey, PA, Douglas Scherr, New York, NY, Joshua Stern, Bronx, NY, Christopher Weight, Minneapolis, MN, Alon Weizer, Ann Arbor, MI, Michael Woods, Chapel Hill, NC, Hristos Kaimakliotis, Indianapolis, IN, Angela Smith, Chapel Hill, NC, Jennifer Linehan, Santa Monica, CA, Jonathan Coleman, New York, NY, Mitchell Humphreys, Scottsdale, AZ, Raymond Pak, Jacksonville, FL, David Lifshitz, Tel Aviv, Israel, Michael Verni, Las Vegas, NV, Elyse Seltzer, New York, NY, Ifat Klein, Ra'anana, Israel, Mark Schoenberg, Bronx, NY, Seth Lerner*, Houston, TX

INTRODUCTION AND OBJECTIVES: Only 30% of UTUC patients receive endoscopic, nephron-sparing treatments due to (1) high grade histology, (2) tumor burden, or (3) unfavorable tumor location. Endoscopically unresectable LG UTUC is routinely managed by nephroureterectomy (NU) predisposing patients to renal insufficiency and the risk of requiring hemodialysis. In this trial, patients received endocavitary therapy using a novel reverse thermal hydrogel containing mitomycin (UGN-101). We report the results of the primary disease evaluation within 6 weeks of completing treatment of patients enrolled with endoscopically unresectable tumors.

METHODS: 71 patients with biopsy proven, LG-UTUC received 6 weekly instillations via retrograde catheter of UGN-101 (maximum volume 15cc; concentration of 4 mg mitomycin/ml) to the renal pelvis and calyces. All patients had measurable tumor at the time of treatment initiation (minimum lesion size >0.5 cm). Four to six weeks following the last instillation, all patients underwent a primary disease evaluation (PDE) including ureteroscopy and wash cytology. A complete response (CR) was defined as negative ureteroscopic evaluation and negative cytology.

RESULTS: Forty-one of 68 patients for whom PDE data are currently available (41/68;60%) achieved a CR after induction therapy and are currently in follow-up. Of the 68 patients, 33 (48.5%) were initially characterized by the treating physician as having endoscopically unresectable tumor at baseline and 19 (58%) achieved a CR at the PDE. Overall, only 3 of 41 patients who achieved a CR have relapsed (1 at 3 months following PDE, and 2 at 9 months); 2 of these patients were considered unresectable prior to UGN-101 treatment. No treatment or disease-related deaths have occurred in the trial to date. The most common adverse events seen in the trial were urinary tract infection, ureteral narrowing and stricture formation.

CONCLUSIONS: Data from the Olympus Trial suggest that a minimally invasive chemoablation approach utilizing UGN-101 in this population results in a high rate of initial disease eradication obviating the need for kidney removal in nearly half of treated individuals. Follow-up to ascertain the durability of CR in this population is ongoing. UGN-101 is an investigational new drug and, if approved by FDA, may provide an alternative for the initial management of patients with LG UTUC, including those with endoscopically unresectable disease.

Source of Funding: Urogen Pharma, Ltd., 499 Park Avenue, Suite 1200, New York, NY 10022

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