UroGen Phase 3 OLYMPUS Trial shows UGN-101 as an initial kidney-sparing treatment option for low-gradeUTUCMay 5, 2019
Complete Response (CR) Rate Consistent at 59 Percent
Six-month Durability Strong with 89 Percent of Evaluable Patients
Remaining in CR
Full Phase 3 Data Anticipated for 2H 2019
NEW YORK–(BUSINESS WIRE)–UroGen Pharma Ltd. (Nasdaq: URGN), a clinical-stage biopharmaceutical
company developing treatments to address unmet needs in the field of
urology, today announced findings from a secondary analysis from the
pivotal Phase 3 OLYMPUS trial which showed that UGN-101 (mitomycin gel)
for instillation, an investigational mitomycin formulation, demonstrated
a 59 percent complete response rate in a subset of patients with
endoscopically unresectable low-grade upper tract urothelial cancer
(UTUC). Findings were presented by Seth Paul Lerner, M.D., FACS,
Professor of Urology at Baylor College of Medicine, in an oral
presentation during the plenary session at the 114th American
Urological Association (AUA) Annual Meeting in Chicago.
The analysis showed that in the OLYMPUS intent-to-treat population, 71
patients had undergone PDE at the time of the analysis and 42 of the 71
patients (59 percent) achieved a CR. Forty-one patients entered
follow-up. Of the evaluated complete responses to date, 27 patients have
undergone a six-month evaluation, and 24 out of 27 patients (89 percent)
have remained disease free at six months. Overall, 5 of 41 patients who
achieved a CR have relapsed at any time during the study.
Of these 71 patients, 34 were initially characterized by the treating
physician as having endoscopically unresectable tumor at baseline, and
20 of 34 of these patients (59 percent) achieved a CR at the PDE.
The company noted that forty-one patients entered follow-up. At the time of the analysis,
66 percent (27/41) of patients have completed a six-month evaluation.
The most common adverse events observed were urinary tract infection,
ureteral narrowing and stricture formation. The majority of ureteral
events were reported as mild to moderate and have resolved.
“The results from the OLYMPUS trial continue to be compelling for new
and recurrent LG UTUC, as well as for those who have unresectable tumors
and would be immediate candidates for kidney removal. For this typically
elderly patient population, kidney preservation is paramount, and these
findings provide evidence-based support for the concept of chemoablation
with UGN-101 as an initial kidney-sparing treatment option for low-grade
UTUC,” said Mark P. Schoenberg, MD, Chief Medical Officer at UroGen.
“The analysis also advances our understanding of durability of response,
which we are pleased to see has remained consistent as the number of
patients who reach the six-month follow-up timepoint increases.”
The Company initiated its rolling submission of the UGN-101 New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) in
December 2018. The FDA previously granted Orphan Drug, Fast Track, and
Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC.
If approved, UGN-101 would be the first drug approved for the
non-surgical treatment of LG UTUC.