Enfortumab vedotin and pembrolizumab: Redefining the standard of care for previously untreated advanced urothelial cancer Review


Authors: Sternschuss, M.; Rosenberg, J. E.
Review Title: Enfortumab vedotin and pembrolizumab: Redefining the standard of care for previously untreated advanced urothelial cancer
Abstract: Combination treatment with Enfortumab vedotin (EV), an antibody drug conjugate targeting Nectin-4 with a monomethyl auristatin E (MMAE) payload, and pembrolizumab, a programmed death 1 (PD-1) inhibitor, has become the new standard of care for previously untreated locally advanced or metastatic urothelial carcinoma. In the recently published phase III study, EV-302, EV and pembrolizumab demonstrated improved outcomes compared to platinum-based chemotherapy, including objective response rate, progression free survival, and an unprecedented median overall survival of 33.8 months (versus 15.9 months; hazard ratio for death 0.51; 95% confidence interval 0.43–0.61; p < 0.00001). We reviewed the mechanism of action, clinical efficacy, exploratory biomarkers, and safety profile of EV and pembrolizumab as monotherapies and combination in urothelial cancer. © 2025 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
Keywords: treatment outcome; overall survival; mortality; review; monotherapy; side effect; antineoplastic agent; biological marker; progression free survival; multiple cycle treatment; antineoplastic combined chemotherapy protocols; pathology; bladder tumor; urinary bladder neoplasms; monoclonal antibody; health care quality; urologic neoplasms; antibodies, monoclonal; drug combination; clinical trials, phase iii as topic; urothelial carcinoma; phase 3 clinical trial; drug therapy; transitional cell carcinoma; adverse drug reaction; phase 3 clinical trial (topic); standard of care; antibody conjugate; immunoconjugates; drug comparison; urinary tract tumor; immune checkpoint inhibitor; antibodies, monoclonal, humanized; antibody-drug conjugate; humans; human; male; vedotin; pembrolizumab; antibody drug conjugate; enfortumab vedotin; special situation for pharmacovigilance
Journal Title: Future Oncology
Volume: 21
Issue: 11
ISSN: 1479-6694
Publisher: Future Medicine  
Date Published: 2025-01-01
Start Page: 1333
End Page: 1348
Language: English
DOI: 10.1080/14796694.2025.2482363
PUBMED: 40129250
PROVIDER: scopus
PMCID: PMC12051594
DOI/URL:
Notes: Review -- Source: Scopus
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  1. Jonathan Eric Rosenberg
    510 Rosenberg