作者: #药闻简讯#$乌龙制药(URGN)$报告 UGN-102 治疗低级别、中度风险非肌浸润性膀胱癌的 P-III 试验 (ATLAS) 结果 公司在《泌尿学杂志》上发表了 P-III 试验结果,评估了 UGN-102(丝裂霉素)膀胱内溶液联合/不联合 TURBT 与单独 TURBT 的比例(1:1),该试验在美国、欧盟和以色列的 282 个临床站点进行...
阿特拉斯的审判 UGN-102之前在3期ATLAS试验中证明了疗效。在书房里。UGN-102合并或不合并TURBT与单独TURBT相比,可改善低级别中危NMIBC患者的预后。 与单独TURBT相比,用UGN-102治疗原发性非手术化疗患者,合并或不合并TURBT可使复发、进展或死亡风险降低55%(无事件生存期[EFS])。15个月时,接受UGN-102合并或不...
港安健康国际医疗介绍,与TURBT相比,UGN-102联合或不联合经TURBT治疗可改善低级别、中度风险非肌层浸润性膀胱癌(NMIBC)患者的无病生存期(DFS),达到了3期ATLAS试验的主要终点。此外,在同一患者群体中评估UGN-102的3期ENVISION试验也达到了完全应答率(CR)这一主要终点。 港安健康科普:UGN-102静脉内溶液是丝裂...
2023年7月28日,UroGen Pharma公布了其抗癌疗法UGN-102(丝裂霉素)在两项关于治疗低分级及中危非肌层浸润性膀胱癌(LG-IR-NMIBC)患者的第三期临床试验ATLAS和ENVISION中,成功实现了主要目标。预计在2024年向相关部门提交新药申请(NDA)。 丝裂霉素是一种抗肿瘤药物,从放线菌的培养液中提取出来,对多种实体瘤具有治...
Response to primary chemoablation with UGN-102 in patients with new or recurrent LG IR NMIBC: post-hoc analysis of the ATLAS trial. J Urol. Published online May 1, 2024. doi:10.1097/01.JU.0001008848.77629.6f.09 3. A phase 3 single-arm study of UGN-102 for treatment of low grade...
with or without transurethral resection of bladder tumors (TURBT) led to an improvement in disease-free survival (DFS) compared with TURBT alone in patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer (NMIBC), meeting the primary end point of the phase 3 ATLAS trial ...
Among patients achieving a CR at 3 months in ATLAS, 79.7% in the UGN-102 arm vs 67.7% in the TURBT arm remained event free 12 months later; the majority with recurrence had low-grade (LG) disease (Table). In ENVISION, 79.6% had a CR at 3 months, and 82.3% remained event free ...
in ATLAS was 0.46 with a 95% confidence interval (0.24, 0.86) favoring the UGN-102 arm. Median DOR was not estimable in any arm due to low recurrence rates; the most common adverse event with UGN-...
Treatment of Low-grade Intermediate-risk Nonmuscle-invasive Bladder Cancer With UGN-102 +/- Transurethral Resection of Bladder Tumor Compared to Transurethral Resection of Bladder Tumor Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS)....
PD30-09RESPONSE TO PRIMARY CHEMOABLATION WITH UGN-102 IN PATIENTS WITH NEW OR RECURRENT LG IR NMIBC: POST-HOC ANALYSIS OF THE ATLAS TRIALdoi:10.1097/01.JU.0001008848.77629.6f.09Prasad, Sandip M.Huang, William C.Shore, Neal D.Hu, Brian...