UROGEN PHARMA LTD. This study evaluated 132 patients treated with JELMYTO from 15 high-volume academic and community centers and characterizes the manner in which urologists are now using JELMYTO in their practices. The study titled, 'Early Experience with UGN-101 for the Treatment of Upper Tract Urothelial Cancer - A Multi-Center Evaluation of Practice Patterns and Outcomes,' is published in Urologic Oncology: Seminars and Original Investigations.
The authors describe several trends in JELMYTO use that differ from the pivotal Olympus study that led to drug approval. Doctors are using JELMYTO for the treatment of large tumors (>3cm in 15% of cases), high grade tumors (9% of cases), and ureteral tumors (35% of cases). In addition, the report documents the use of JELMYTO as a valuable multimodal adjunct following complete laser tumor ablation. JELMYTO is indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). Primary chemoablation resulted in a 70% complete response (CR) rate for patients with tumors less than 1cm (CR rates following primary therapy were lower for larger tumors consistent with previous reporting) while 69% achieved CR when JELMYTO was combined with laser ablation. CR in the Olympus trial was 59%.
Almost half of the patients in the review were treated by antegrade administration of JELMYTO through a nephrostomy tube. The Olympus cohort was treated exclusively by retrograde catheter passed into the upper tract through the bladder. The authors of a recent single-center retrospective review observed that antegrade administration of JELMYTO was associated with a lower rate of ureteric stenosis than the retrograde approach as observed in OLYMPUS, and this larger multi-center review supports that earlier observation. The rate of ureteric stenosis in the Olympus trial was 44%. In this multi-center study it was 23%.
The limitations of this study include the retrospective design, lack of a control group, the lack of a centralized pathology review, and standardized clinicopathologic assessment.
To further explore the full potential of JELMYTO for the treatment of patients with UTUC, investigators are in the process of enrolling the prospective and retrospective uTRACT Registry to capture data in a large scale, standardized manner to report further on patient outcomes following JELMYTO treatment including longitudinal follow-up.
This study provides valuable insights into how physicians are utilizing JELMYTO in the real-world and reinforces the genuine clinical value of this therapy for patients with LG-UTUC,' said
About UTUC
Approximately 5-7% of urothelial cancer occurs in the upper lining of the kidney, called the calyx and renal pelvis. It could also occur in one or both of the ureter(s), the tubes that lead from the kidneys to the bladder. Cancer in the renal pelvis or ureter(s) is called upper tract. LG-UTUC is usually not very aggressive and is slow to spread but has a high recurrence rate. High-grade UTUC can be more aggressive. It may spread to other parts of the urinary tract, or to other parts of the body.
JELMYTO is approved for the treatment of adults with LG-UTUC. LG-UTUC is a rare disease managed by endoscopic methods and radical nephroureterectomy. Endoscopic resection and laser ablation attempt to preserve the kidney, though there is a high risk of recurrence that may eventually necessitate removal of the kidney. Although kidney removal is the gold standard for treatment of high-grade UTUC, it may be over-treatment in LG-UTUC, as kidney removal offers similar five-year survival as kidney-sparing procedures but is associated with significant morbidity. JELMYTO is efficacious as a primary chemoablative therapy in patients with LG-UTUC.
About JELMYTO
JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for primary chemoablative treatment of LG-UTUC in adults. It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.
About
UroGen is biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. UroGen's sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen's first commercial product JELMYTO (mitomycin) for pyelocalyceal solution, and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer, are designed to ablate tumors by non-surgical means. UroGen is headquartered in
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding additional analysis from the retrospective study of JELMYTO as well as prospective and retrospective data from the uTRACT Patient Registry; the potential of UroGen's proprietary RTGel technology to improve therapeutic profiles of existing drugs and UroGen's sustained release technology making local delivery potentially more effective as compared to other treatment options. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: results from initial reports from the retrospective study evaluating post-commercial utilization of JELMYTO in the publication may not be indicative of results that may be observed in future clinical practice and may differ from additional analysis of the data from the study; potential safety and other complications from JELMYTO use in diverse UTUC patient types and our RTGel technology may not perform as expected and we may not successfully develop and receive regulatory approval of any other product that incorporates our RTGel technology. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen's Form 10-Q filed with the
Contact:
Email: vincent.perrone@urogen.com
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