“The median DOR of 47.8 months in patients who achieved complete response with JELMYTO provides evidence of robust durability in maintaining control of low-grade UTUC over an extended period,” said Phillip Pierorazio, M.D., Chief, Section of Urology, Penn Presbyterian Medical Center, Professor of Surgery, Hospital of the University of Pennsylvania in Philadelphia, P.A., study author and member of the American Urological Association (AUA)/ Annual Society of Urological Oncology (SUO) UTUC Guideline Committee. “The AUA/SUO recommend that urologists use kidney-sparing techniques as the preferred management strategy for patients with low-grade UTUC when possible. JELMYTO, with this evidence for extended durability of complete response, offers the opportunity for durable recurrence-free intervals.”Of the 71 patients enrolled in OLYMPUS, 41 achieved a complete response after treatment with JELMYTO and had a median duration of response of 47.8 months (95% CI 13.0, not estimable), with median follow-up of 28.1 months (95% CI 13.1, 57.5).
"Previous research indicates that managing relapse and preserving organ function should be the primary treatment goal for LG-UTUC due to the low risk of disease progression,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “We are encouraged by the study's findings providing compelling evidence for favorable long-term durability of JELMYTO as a primary treatment for LG-UTUC, with increasing evidence showing extended response times in some patients."
The analysis has certain limitations, including its post-hoc nature and the inherent selection bias of the 20 patients enrolled in the long-term follow-up study.
To further explore the potential of JELMYTO in treating patients with UTUC, investigators are currently enrolling participants in the JELMYTO uTRACT Registry to gather longitudinal real-world usage data. As of July 10, 19 sites have been activated with 191 patients enrolled.
Source: UroGen Pharma Ltd. (2024). New Data from a Long-Term Follow-up Study to the OLYMPUS Trial Show Median Duration of Response of Four Years in Patients Who Achieved a Complete Response with JELMYTO® [Press release]. https://investors.urogen.com/news-releases/news-release-details/new-data-long-term-follow-study-olympus-trial-show-median.
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