TMCnet News
UroGen Pharma Announces Positive Interim Results from Pivotal Phase 3 OLYMPUS Trial of UGN-101 (MitoGel™) for Non-Surgical Treatment of Upper Tract Urothelial Cancer (UTUC)Interim Results Showed Complete Response (CR) Rate of 59 Percent in Patients with Low-Grade UTUC CRs to Date Remain Durable at Three, Six and Nine-Month Follow-Up RA’ANANA, Israel and NEW YORK, May 21, 2018 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced new findings from an interim analysis of the ongoing pivotal Phase 3 OLYMPUS clinical trial of UGN-101 (MitoGel™), an investigational mitomycin formulation for the non-surgical treatment of low-grade upper tract urothelial cancer (UTUC). 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 (AUA) Annual Meeting in San Francisco. The interim analysis from this international, multi-center trial showed a complete response (CR) rate of 59 percent in 34 patients who were evaluated for primary disease evaluation (PDE, or the primary endpoint). 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 (59 percent) achieved a CR, defined as a negative ureteroscopic evaluation and a negative wash cytology. In addition, five of 34 patients (15 percent) 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. “These interim data from the OLYMPUS trial are promising and demonstrate the potential of UGN-101 to become the first drug ever approved for low-grade UTUC. We are pleased to see that the results to date from this trial improve upon the 44 percent complete response rate on an intent to treat basis observed in our similarly designed Compassionate Use program of UGN-101,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “Currently, the thousands of patients living with UTUC do not have many therapeutic options to manage their disease. With UGN-101, we hope to change the treatment paradigm for low-grade UTUC by potentially enabling the treatment of these tumors by non-surgical means, sparing patients from the risks and complications associated with repetitive surgical procedures and potential kidney removal.” “We are excited about the interim analysis from our pivotal Phase 3 trial of UGN-101 presented today. This is an important step toward our anticipated Q1 2019 submission of a New Drug Application to the U.S. Food and Drug Administration,” said Ron Bentsur, Chief Executive Officer of UroGen. “This interim analysis also demonstrates the potential of our proprietary RTGel™ sustained release platform, which we believe has the potential to transform existing treatment paradigms across a number of urologic conditions. We look forward to continuing to advance our pipeline towards this end.” The OLYMPUS trial continues to enroll patients, and top-line results are expected in the second half of 2018. Details ofAUA Oral Presentation Session: Plenary, Next Frontier Title: Non-Surgical Management of Low-Grade Upper Tract Urothelial Cancer: An Interim Analysis of the International Multicenter OLYMPUS Trial Presenter: Seth Paul Lerner, M.D., FACS, Professor of Urology, Baylor College of Medicine Time: Monday, May 21, 2018, 10:40-10:50 AM PDT Location: MCC NORTH, Hall E, The Moscone Center About the Phase 3 OLYMPUS Trial About Upper Tract Urothelial Cancer (UTUC) The current standard of care for UTUC is complete or partial surgical removal of the involved kidney or ureter. For patients with a bilateral disease, an anatomic or functionally solitary kidney, medical comorbidities or low-grade disease who present with a limited number of tumors, a kidney-conserving alternative is considered, if possible. However, due to the specific anatomy and physiology of the upper urinary tract and renal pelvis, organ-sparing endoscopic resection and instillation of neoadjuvant or adjuvant chemotherapy is often challenging, leading to high rates of recurrence. Additionally, continuous urine flow, the inability of the upper urinary tract to retain a liquid volume under normal circumstances, and the effects of peristalsis, or muscle contraction, result in short exposure time of active agents in the target area. This leads to poor efficacy and limited use of standard therapeutic agents in the treatment of UTUC. About UGN-101 (MitoGel™) The U.S. Food and Drug Administration has granted both Orphan Drug and Fast Track designations to UGN-101 for the treatment of low-grade UTUC. About UroGen Pharma Ltd. Forward-Looking Statements UROGEN CONTACT: Kate Bechtold |