UroGen Pharma Announces UGN-102 Long-Term Results In The Phase 3 ENVISION Trial, Potentially Paving The Way For First FDA-Approved Treatment For LG-IR-NMIBC; UGN-102 Demonstrated 82.3% Duration Of Response At 12 Months In Patients Who Achieved...
UroGen Pharma Announces UGN-102 Long-Term Results In The Phase 3 ENVISION Trial, Potentially Paving The Way For First FDA-Approved Treatment For LG-IR-NMIBC; UGN-102 Demonstrated 82.3% Duration Of Response At 12 Months In Patients Who Achieved...
UroGen Pharma Announces UGN-102 Long-Term Results In The Phase 3 ENVISION Trial, Potentially Paving The Way For First FDA-Approved Treatment For LG-IR-NMIBC; UGN-102 Demonstrated 82.3% Duration Of Response At 12 Months In Patients Who Achieved Complete Response At 3 Months; 79.6% Complete Response Rate At 3 Months
烏龍製藥宣佈UGN-102開多期3 ENVISION試驗的長期結果，有望爲LG-IR-NMIBC的首個FDA批准治療鋪平道路；UGN-102在12個月時顯示出82.3%的持續反應時長，對於3個月內完全反應的患者；3個月時的完全反應率爲79.6%
- UGN-102 demonstrated 82.3% duration of response (DOR) at 12 months in patients who achieved complete response at 3 months
- 79.6% complete response rate at 3 months in patients treated with UGN-102
- Safety profile consistent with prior clinical trials of UGN-102
- UGN-102在12個月時顯示出82.3%的反應持續時間(DOR)，對於在3個月內完成反應的患者
- 用UGN-102治療的患者在3個月時，完全反應率爲79.6%
- 安全性與UGN-102先前臨床試驗一致
UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the presentation of the Phase 3 ENVISION trial's efficacy and safety results at the Society of Urologic Oncology (SUO) annual meeting in Dallas, TX. These results, published online in the Journal of Urology in October, demonstrate that treatment with investigational therapy UGN-102, a mitomycin-based intravesical solution, resulted in a high and clinically meaningful complete response rate that was durable in patients with recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC).
烏龍製藥有限公司(納斯達克: URGN)是一家專注於開發和商業化治療尿路上皮和特殊癌症創新解決方案的生物技術公司，今天在達拉斯舉行的泌尿腫瘤學會(SUO)年會上宣佈了第3期ENVISION試驗的療效和安全性結果。這些結果已於10月在《泌尿學雜誌》在線發表，顯示用UGN-102研究性治療，一種米多黴素基膀胱內溶液，導致在具有複發性低級中風險非肌層侵襲性膀胱癌(LG-IR-NMIBC)患者中具有高且臨床意義重大的持久完全反應率。