UroGen Pharma announced new findings from an interim analysis of the ongoing pivotal Phase 3 OLYMPUS clinical trial of UGN-101, an investigational mitomycin formulation for the non-surgical treatment of low-grade upper tract urothelial cancer. Results were presented by Seth Paul Lerner, M.D., FACS, Principal Investigator of the OLYMPUS trial and Professor of Urology at Baylor College of Medicine in Houston in an oral presentation during the plenary session at the 113th American Urological Association’s Annual Meeting in San Francisco. The interim analysis from this international, multi-center trial showed a complete response rate of 59% in 34 patients who were evaluated for primary disease evaluation. PDE is conducted four to six weeks after completion of UGN-101 treatment, which was administered once weekly for six weeks. Results showed that 20 of the interim analysis intent to treat population of 34 patients achieved a CR, defined as a negative ureteroscopic evaluation and a negative wash cytology. In addition, five of 34 patients achieved a partial response. Approximately 39 percent of tumors treated were categorized as unresectable by surgery at baseline. The CRs to date have been durable. Of the 20 patients who achieved a CR, 13 patients have reached three-month follow-up and all remain in CR. Four of these 13 patients have reached six-month follow-up and one of the 13 patients has reached nine-month follow-up. All remain in CR. UGN-101 appeared to be well-tolerated with most treatment-emergent adverse events characterized as mild or moderate and transient. These included urinary tract infection, flank pain, ureteral narrowing and hydronephrosis and time-limited creatinine elevation. The OLYMPUS trial continues to enroll patients, and top-line results are expected in 2H18.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.