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      Profile of Enfortumab Vedotin in the Treatment of Urothelial Carcinoma: The Evidence to Date

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          Abstract

          Nowadays the therapeutic landscape for advanced and metastatic urothelial carcinoma continues to evolve. The recent regulatory approval of enfortumab vedotin (EV) for the treatment of advanced urothelial cancer confirms the evolving role of antibody-drug conjugates. EV demonstrates a favorable profile in heavily pretreated patients with locally advanced or metastatic urothelial carcinoma. Early survival reports demonstrate a significant antitumor effectiveness along with a rather acceptable safety profile in a difficult-to-treat population.

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          Most cited references 25

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          Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods

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            The immunoglobulin-like cell adhesion molecule nectin and its associated protein afadin.

            Nectins are immunoglobulin-like cell adhesion molecules (CAMs) that compose a family of four members. Nectins homophilically and heterophilically interact in trans with each other to form cell-cell adhesions. In addition, they heterophilically interact in trans with other immunoglobulin-like CAMs. Nectins bind afadin, an actin filament (F-actin)-binding protein, at its cytoplasmic tail and associate with the actin cytoskeleton. Afadin additionally serves as an adaptor protein by further binding many scaffolding proteins and F-actin-binding proteins and contributes to the association of nectins with other cell-cell adhesion and intracellular signaling systems. Nectins and afadin play roles in the formation of a variety of cell-cell junctions cooperatively with, or independently of, cadherins. Cooperation between nectins and cadherins is required for the formation of cell-cell junctions; cadherins alone are not sufficient. Additionally, nectins regulate many other cellular activities (such as movement, proliferation, survival, differentiation, polarization, and the entry of viruses) in cooperation with other CAMs and cell surface membrane receptors.
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              Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy

              PURPOSE Locally advanced or metastatic urothelial carcinoma is an incurable disease with limited treatment options, especially for patients who were previously treated with platinum and anti–programmed death 1 or anti–programmed death ligand 1 (PD-1/L1) therapy. Enfortumab vedotin is an antibody–drug conjugate that targets Nectin-4, which is highly expressed in urothelial carcinoma. METHODS EV-201 is a global, phase II, single-arm study of enfortumab vedotin 1.25 mg/kg (intravenously on days 1, 8, and 15 of every 28-day cycle) in patients with locally advanced or metastatic urothelial carcinoma who were previously treated with platinum chemotherapy and anti–PD-1/L1 therapy. The primary end point was objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review. Key secondary end points were duration of response, progression-free survival, overall survival, safety, and tolerability. RESULTS Enfortumab vedotin was administered to 125 patients with metastatic urothelial carcinoma. Median follow-up was 10.2 months (range, 0.5 to 16.5 months). Confirmed objective response rate was 44% (95% CI, 35.1% to 53.2%), including 12% complete responses. Similar responses were observed in prespecified subgroups, such as those patients with liver metastases and those with no response to prior anti–PD-1/L1 therapy. Median duration of response was 7.6 months (range, 0.95 to 11.30+ months). The most common treatment-related adverse events were fatigue (50%), any peripheral neuropathy (50%), alopecia (49%), any rash (48%), decreased appetite (44%), and dysgeusia (40%). No single treatment-related adverse events grade 3 or greater occurred in 10% or more of patients. CONCLUSION Enfortumab vedotin demonstrated a clinically meaningful response rate with a manageable and tolerable safety profile in patients with locally advanced or metastatic urothelial carcinoma who were previously treated with platinum and anti–PD-1/L1 therapies.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                dddt
                dddt
                Drug Design, Development and Therapy
                Dove
                1177-8881
                11 February 2021
                2021
                : 15
                : 453-462
                Affiliations
                [1 ]Department of Urology, Al Zahraa Hospital, University Medical Center, Lebanese University , Beirut, Lebanon
                [2 ]2nd Department of Urology, School of Medicine, Sismanoglio Hospital, National and Kapodistrian University of Athens , Athens, Greece
                [3 ]Department of Surgery, School of Medicine, Aretaieion Hospital, National and Kapodistrian University of Athens , Athens, Greece
                Author notes
                Correspondence: Athanasios Papatsoris 2nd Department of Urology, School of Medicine, Sismanoglio Hospital, National and Kapodistrian University of Athens , Athens, GreeceFax +302132058605 Email agpapatsoris@yahoo.gr
                Article
                240854
                10.2147/DDDT.S240854
                7886109
                © 2021 Moussa et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

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                Figures: 0, Tables: 4, References: 30, Pages: 10
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