On February 3, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, reported the initiation of its Phase 3 ENVISION study of UGN-102 (mitomycin) for intravesical solution, in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC) (Press release, UroGen Pharma, FEB 3, 2022, View Source [SID1234607670]).
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ENVISION is a single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low-grade, intermediate-risk NMIBC. The study design is similar to the Phase 2b OPTIMA II study in that patients will have the same clinical characteristics, treatment regimen, assessment, and qualitative follow up but with different endpoints. ENVISION is expected to enroll approximately 220 patients across 90 sites. Based on discussions with the U.S. Food and Drug Administration (FDA), and enrollment expected by end of 2022, assuming positive findings, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024.
"The start of the ENVISION trial marks the final phase of validating primary chemoablation for the treatment of recurrent intermediate risk NMIBC," said Sandip Prasad, Urologist, Atlantic Health System, Morristown Medical Center, NJ, and lead study investigator for the ENVISION trial. "This study is designed to support the clinical potential of UGN-102 as a new treatment for patients that are under-served by the current standard of care, including those patients at risk for recurrence and those that are unwilling or unable to endure surgery or anesthesia."
For the new Phase 3 trial, study participants will receive 6 once-weekly intravesical instillations of UGN-102. The planned primary endpoint is the complete response rate at three months after the first instillation, and the key secondary endpoint will be durability over time in patients who achieve complete response at the three-month assessment.
"We have achieved consistent results with similar study designs in the past and believe that it increases our probability for technical and regulatory success for UGN-102 in patients with low-grade, intermediate-risk NMIBC," added Mark Schoenberg, Chief Medical Officer, UroGen. "We look forward to reporting data from ATLAS and acquiring new scientific evidence from ENVISION as we continue to explore the potential benefits of chemoablation in other types of bladder cancer, including high-grade disease and other specialty cancers."
About LG IR NMIBC
Out of the 80,000 estimated cases of bladder cancer per year in the U.S., approximately 35,000 are low-grade NMIBC patients comprised of both low-risk (approximately 15,000) and intermediate risk (approximately 20,000). These patients face a future of recurrence and additional surgeries.
Recurrence in low-grade intermediate-risk NMIBC is pervasive and often underestimated. In patients who recur, approximately 68 percent will experience two or more recurrence episodes throughout the course of their disease, a high and frequent rate in contrast to other non-metastatic cancers.
Currently, the only effective primary treatment available is a surgical procedure known as transurethral resection of bladder tumor, or TURBT. Every time TURBT is performed it imposes more burden and serious risks on patients. Approximately 25 percent of patients are not appropriate for TURBT, whether due to physical factors such as age and comorbidities or an unwillingness to undergo surgery.