TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors

Tagawa, Scott T.; Balar, Arjun V.; Petrylak, Daniel P.; Kalebasty, Arash Rezazadeh; Loriot, Yohann; Fléchon, Aude; Jain, Rohit K.; Agarwal, Neeraj; Bupathi, Manojkumar; Barthelemy, Philippe; Beuzeboc, Philippe; Palmbos, Phillip; Kyriakopoulos, Christos E.; Pouessel, Damien; Sternberg, Cora N.; Hong, Quan; Goswami, Trishna; Itri, Loretta M.; Grivas, Petros

doi:10.1200/jco.20.03489

Cited by 543Bladder and Urothelial Cancer TreatmentsCancer Immunotherapy and BiomarkersUrinary Tract Infections Management

TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors

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Tagawa, Scott T., Balar, Arjun V., Petrylak, Daniel P., Kalebasty, Arash Rezazadeh, Loriot, Yohann, Fléchon, Aude, Jain, Rohit K., Agarwal, Neeraj +11 more·2021·Journal of Clinical Oncology

DOI 10.1200/jco.20.03489PMC PMC8315301

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Abstract

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 included 113 patients (78% men; median age, 66 years; 66.4% visceral metastases; median of three [range, 1-8] prior therapies). At a median follow-up of 9.1 months, the ORR was 27% (31 of 113; 95% CI, 19.5 to 36.6); 77% had decrease in measurable disease. Median duration of response was 7.2 months (95% CI, 4.7 to 8.6 months), with median progression-free survival and OS of 5.4 months (95% CI, 3.5 to 7.2 months) and 10.9 months (95% CI, 9.0 to 13.8 months), respectively. Key grade ≥ 3 treatment-related adverse events included neutropenia (35%), leukopenia (18%), anemia (14%), diarrhea (10%), and febrile neutropenia (10%), with 6% discontinuing treatment because of treatment-related adverse events. CONCLUSION: SG is an active drug with a manageable safety profile with most common toxicities of neutropenia and diarrhea. SG has notable efficacy compared with historical controls in pretreated mUC that has progressed on both prior PLT regimens and CPI. The results from this study supported accelerated approval of SG in this population.

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The TROP2-targeted antibody-drug conjugates sacituzumab govitecan and datopotamab deruxtecan showed promising clinical efficacy in several cancer entities, including locally advanced or metastatic triple-negative breast cancer, hormone receptor-positive and HER2-negative breast cancer, and locally advanced or metastatic urothelial carcinoma.
“The TROP2-targeted ADCs sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) showed promising clinical efficacy in several cancer entities, including locally advanced or metastatic triple-negative breast cancer,84 hormone receptor-positive and HER2-negative breast cancer85 and locally advanced or metastatic urothelial carcinoma.86”
From Current and emerging concepts for systemic treatment of metastatic colorectal cancer (2025) · cites this paper as [86]

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[43]Grivas P Loriot Y Feyerabend S, et al: Rucaparib for recurrent, locally advanced or metastatic urothelial carcinoma: Results from ATLAS, a phase 2, open-label trial [oral presentation], Annual Genitourinary Cancers Symposium. San Francisco, CA, 2020
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Authors: Tagawa, S. T., Balar, A. V., Petrylak, D. P., Kalebasty, A. R., Loriot, Y., Fléchon, A., Jain, R. K., Agarwal, N., Bupathi, M., Barthelemy, P., Beuzeboc, P., Palmbos, P., Kyriakopoulos, C. E., Pouessel, D., Sternberg, C. N., Hong, Q., Goswami, T., Itri, L. M., & Grivas, P.
Affiliations: Weill Cornell Medicine (US)
NYU Langone’s Laura and Isaac Perlmutter Cancer Center (US)
Yale University (US)
Norton Healthcare (US)
Institut Gustave Roussy (FR)
Centre Léon Bérard (FR)
Moffitt Cancer Center (US)
Huntsman Cancer Hospital, Salt Lake City, UT
Rocky Mountain Cancer Centers (US)
Hôpitaux Universitaires de Strasbourg/Institut de Cancérologie Strasbourg Europe, Strasbourg, France
Hôpital Foch (FR)
U-M Rogel Cancer Center (US)
University of Wisconsin–Madison (US)
Institut Claudius Regaud (FR)
Immunomedics (United States) (US)
Seattle Cancer Care Alliance (US)
Corresponding author: Tagawa, Scott T.
ORCID: Tagawa, Scott T.
Balar, Arjun V.
Petrylak, Daniel P.
Kalebasty, Arash Rezazadeh
Loriot, Yohann
Fléchon, Aude
Jain, Rohit K.
Agarwal, Neeraj
Bupathi, Manojkumar
Beuzeboc, Philippe
Palmbos, Phillip
Kyriakopoulos, Christos E.
Pouessel, Damien
Sternberg, Cora N.
Grivas, Petros
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2021-08-01
Volume: 39
Issue: 22
Pages: 2474-2485
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.20.03489
PMC: PMC8315301
OpenAlex: W3157821912
Cited by: 543
References: 50
Citations by year: 2026: 57 · 2025: 110 · 2024: 136 · 2023: 125 · 2022: 85 · 2021: 29
FWCI: 87.98
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
Locations: Journal of Clinical Oncology (publishedVersion, cc-by-nc-nd)
PubMed Central (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
Funders: National Institutes of Health (UL1TR001863)
National Center for Advancing Translational Sciences
Topics: Health Sciences › Medicine › Surgery › Bladder and Urothelial Cancer Treatments
Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Epidemiology › Urinary Tract Infections Management
Keywords: sacituzumab govitecan, metastatic urothelial carcinoma, TROP2, antibody-drug conjugates, SN-38, platinum-refractory disease, objective response rate, progression-free survival, neutropenia, diarrhea, treatment-related adverse events, second-line therapy, third-line therapy, visceral metastases, duration of response
MeSH terms: Immune Checkpoint Inhibitors, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Female, Humans, Male, Middle Aged, Organoplatinum Compounds, Urologic Neoplasms, Cohort Studies, Immunoconjugates, Antibodies, Monoclonal, Humanized

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TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors

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