UroGen Pharma announces positive results of UGN-101 from pivotal Phase 3 OLYMPUS trial for the non-surgical treatment of patients with low-grade upper tract urothelial cancer (LG UTUC)

Source: CBNB

2019/02/12

Source: Company press release, 8 Jan 2019 , 8 Jan 2019 , Website: http://www.biospace.com UroGen Pharma Ltd, a clinical-stage biopharmaceutical company
developing treatments to address unmet needs in the field of urology,
announced on 8 Jan 2019 topline results from the ongoing pivotal Phase 3
OLYMPUS clinical trial of UGN-101 (mitomycin gel) for instillation, an
investigational mitomycin formulation for the non-surgical treatment of
low-grade upper tract urothelial cancer (UTUC). This analysis 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.
This international, multicentre trial completed enrolment with 71 patients
in Dec 2018. Of the 71 patients enrolled in the trial, 61 patients have been
evaluated for the primary endpoint which was a CR as defined as a negative
ureteroscopic evaluation and a negative wash cytology. The remaining 10
patients are awaiting PDE evaluation. Approximately 45 percent of tumors
treated were categorized as unresectable by surgery at baseline. Of the
patients who achieved CR, UroGen now has six-month durability on half of
these patients. Durability is a key secondary endpoint for the trial. The
safety profile of UGN-101 continues to be acceptable with most
treatment-emergent adverse events characterized as mild or moderate and
transient and in line with ureteral procedures. These included ureteral
narrowing and hydronephrosis, urinary tract infection, flank pain and
creatinine elevation. UroGen intends to seek regulatory approval of UGN-101
in LG UTUC based on data from all 71 patients and initiated its rolling
submission of the New Drug Application (NDA) to the US Food and Drug
Administration (FDA) in Dec 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. Original Source: UroGen Pharma Ltd,
2019. From website: http://www.biospace.com. Released to ICIS 12 Feb 2019[This article was prepared by Chemical Business NewsBase (CBNB), a third party premium option available through ICIS news. For any queries about the content please contact: John Godfrey, godfreyj@elsevier.com, +44 (0) 1223 463167]