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 |