作者
Scott T Tagawa, Arjun V Balar, Daniel P Petrylak, Arash Rezazadeh Kalebasty, Yohann Loriot, Aude Fléchon, Rohit K Jain, Neeraj Agarwal, Manojkumar Bupathi, Philippe Barthelemy, Philippe Beuzeboc, Phillip Palmbos, Christos E Kyriakopoulos, Damien Pouessel, Cora N Sternberg, Quan Hong, Trishna Goswami, Loretta M Itri, Petros Grivas
发表日期
2021/8/1
期刊
Journal of Clinical Oncology
卷号
39
期号
22
页码范围
2474-2485
出版商
Wolters Kluwer Health
简介
PURPOSE
Patients with metastatic urothelial carcinoma (mUC) who progress on platinum-based combination chemotherapy (PLT) and checkpoint inhibitors (CPIs) have limited options that offer objective response rates (ORRs) of approximately 10% with a median overall survival (OS) of 7-8 months. Sacituzumab govitecan (SG) is a TROP-2–directed antibody-drug conjugate with an SN-38 payload that has shown preliminary activity in mUC.
METHODS
TROPHY-U-01 (ClinicalTrials.gov identifier: NCT03547973) is a multicohort, open-label, phase II, registrational study. Cohort 1 includes patients with locally advanced or unresectable or mUC who had progressed after prior PLT and CPI. Patients received SG 10 mg/kg on days 1 and 8 of 21-day cycles. The primary outcome was centrally reviewed ORR; secondary outcomes were progression-free survival, OS, duration of response, and safety.
RESULTS
Cohort 1 …
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ST Tagawa, AV Balar, DP Petrylak, AR Kalebasty… - Journal of Clinical Oncology, 2021