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

References

• FerlayJ, ColombetM, SoerjomataramI, et al. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods. Int J Cancer. 2019;144(8):1941–1953. doi:10.1002/ijc.3193730350310
   PubMed Web of Science ®Google Scholar
• TeohJY, HuangJ, KoWY, et al. Global trends of bladder cancer incidence and mortality, and their associations with tobacco use and gross domestic product per capita. Eur Urol. 2020;78:893–906. doi:10.1016/j.eururo.2020.09.00632972792
   PubMed Web of Science ®Google Scholar
• WitjesJA, BruinsHM, CathomasR, et al. EAU Guidelines on Muscle-Invasive and Metastatic Bladder Cancer. European Association of Urology (EAU); 2020.
   Google Scholar
• Cancer Stat Facts: Bladder Cancer. NIH NCI: surveillance, epidemiology and end results programme; 2019 Available from: https://seer.cancer.gov/statfacts/html/urinb.html. Accessed 119, 2021.
   Google Scholar
• SternbergCN, VogelzangNJ. Gemcitabine, paclitaxel, pemetrexed and other newer agents in urothelial and kidney cancers. Crit Rev Oncol Hematol. 2003;46(46 Suppl):S105–15. doi:10.1016/S1040-8428(03)00068-412850531
   PubMed Web of Science ®Google Scholar
• von der MaaseH, SengelovL, RobertsJT, et al. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005;23:4602. doi:10.1200/JCO.2005.07.75716034041
   PubMed Web of Science ®Google Scholar
• SternbergCN, de MulderP, SchornagelJH, et al. Seven year update of an EORTC Phase III trial of high-dose intensity M-VAC chemotherapy and G-CSF versus classic M-VAC in advanced urothelial tract tumours. Eur J Cancer. 2006;42(1):50–54. doi:10.1016/j.ejca.2005.08.03216330205
   PubMed Web of Science ®Google Scholar
• Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-type-therapy-treat-advanced-urothelial-cancer. Accessed 202, 2021.
   Google Scholar
• BoniV, SharmaMR, PatnaikA. The resurgence of antibody drug conjugates in cancer therapeutics: novel targets and payloads. Am Soc Clin Oncol Educ Book. 2020;40:1–17. doi:10.1200/EDBK_281107
   Google Scholar
• TakaiY, IkedaW, OgitaH, et al. The immunoglobulin-like cell adhesion molecule nectin and its associated protein afadin. Annu Rev Cell Dev Biol. 2008;24:309–342. doi:10.1146/annurev.cellbio.24.110707.17533918593353
   PubMed Web of Science ®Google Scholar
• JainRK, SkeltonWP, ZhangJ. Emerging treatment options for the treatment of metastatic urothelial cancer: therapeutic potential of enfortumab vedotin. Cancer Manag Res. 2020;20:8379–8386. doi:10.2147/CMAR.S224223
   Web of Science ®Google Scholar
• Challita-EidPM, SatpayevD, YangP, et al. Enfortumab vedotin antibody-drug conjugate targeting Nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer models. Cancer Res. 2016;76:3003–3013. doi:10.1158/0008-5472.CAN-15-131327013195
   PubMed Web of Science ®Google Scholar
• Al ShaerD, Al MusaimiO, AlbericioF, de la TorreBG. 2019 FDA TIDES (peptides and oligonucleotides) harvest. Pharmaceuticals (Basel). 2020;13(3):40. doi:10.3390/ph13030040
   Google Scholar
• Padcev approval letter; 2019 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761137Orig1s000ltr.pdf. Accessed 1019, 2020.
   Google Scholar
• NCCN. Clinical practice guidelines in oncology (NCCN guidelines®). Bladder Cancer. 2020.
   Google Scholar
• RosenbergJ, SridharSS, ZhangJ, et al. EV-101: a phase i study of single-agent enfortumab vedotin in patients with nectin-4–positive solid tumors, including metastatic urothelial carcinoma. J Clin Oncol. 2020;38(10):1041–1049. doi:10.1200/JCO.19.0204432031899
   PubMed Web of Science ®Google Scholar
• RosenbergJE, O’DonnellPH, BalarAV, et al. Pivotal trial of enfortumab vedotin in urothelial carcinoma after platinum and anti-programmed death/programmed death ligand 1 therapy. J Clin Oncol. 2019;37(29):2592–2600. doi:10.1200/JCO.19.0114031356140
   PubMed Web of Science ®Google Scholar
• Maas M, Stuhler V, Walz S, Stenzl A, Bedke J. Enfortumab vedotin -next game- changer in urothelial cancer. Expert Opin Biol Ther. 2020;1–9. doi:10.1080/14712598.2021.1865910
   Google Scholar
• HoimesCJ, RosenbergJE, SrinivasS, et al. 4844 - EV-103: initial results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. Ann Oncol. 2019;30(suppl_5):v356–v402. doi:10.1093/annonc/mdz249
   Google Scholar
• van der HeijdenMS, GuptaS, GalskyMD, et al. 798TiP - study EV-302: a 3-arm, open-label, randomized phase III study of enfortumab vedotin plus pembrolizumab and/or chemotherapy, versus chemotherapy alone, in untreated locally advanced or metastatic urothelial cancer. Ann Oncol. 2020;31(suppl_4):S550–S550. doi:10.1016/j.annonc.2020.08.2069
   Web of Science ®Google Scholar
• TakahashiS, UemuraM, KimuraT, et al. A phase I study of enfortumab vedotin in Japanese patients with locally advanced or metastatic urothelial carcinoma. Invest New Drugs. 2020;38:1056–1066. doi:10.1007/s10637-019-00844-x31444589
   PubMed Web of Science ®Google Scholar
• McGregorBA, SonpavdeG. Enfortumab Vedotin, a fully human monoclonal antibody against Nectin 4 conjugated to monomethyl auristatin E for metastatic urothelial Carcinoma. Expert Opin Investig Drugs. 2019;28(10):821–826. doi:10.1080/13543784.2019.1667332
   PubMed Web of Science ®Google Scholar
• PistalmatzianN, TzannisK, PissanidouV, et al. Treatment of relapsed urothelial bladder cancer with vinflunine: real-world evidence by the Hellenic Genitourinary Cancer Group. Anticancer Drugs. 2016;27(1):48–53. doi:10.1097/CAD.000000000000029726421462
   PubMed Web of Science ®Google Scholar
• FDA. Resources for information on approved drugs. 2021 Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grantsaccelerated-approval-erdafitinib-metastatic-urothelial-carcinoma. Accessed 202, 2021.
   Google Scholar
• GopalakrishnanD, KoshkinVS, OrnsteinMC, et al. Immune checkpoint inhibitors in urothelial cancer: recent updates and future outlook. Ther Clin Risk Manag. 2018;14:1019–1040. doi:10.2147/TCRM.S15875329892196
   PubMed Web of Science ®Google Scholar
• GrivasP, DrakakiA, FriedlanderTW, et al. Conceptual framework for therapeutic development beyond anti-PD-1/PD-L1 in urothelial cancer. Am Soc Clin Oncol Educ Book. 2019;39:284–300. doi:10.1200/EDBK_23744931099684
   PubMedGoogle Scholar
• SasakiR, FujimuraT, LyuC, et al. Severe eczematoid and lichenoid eruption with full-thickness epidermal necrosis developing from metastatic urothelial cancer treated with enfortumab vedotin. J Dermatol. 2020;47:1436–1438. doi:10.1111/1346-8138.1557732860247
   PubMed Web of Science ®Google Scholar
• KeertyD, GrahamL, HaynesE, et al. Flexural exanthema from enfortumab vedotin. Cureus. 2020;12(5):e8102.32542157
   PubMed Web of Science ®Google Scholar
• NadalR, BellmuntJ. Management of metastatic bladder cancer. Cancer Treat Rev. 2019;76:10–21. doi:10.1016/j.ctrv.2019.04.00231030123
   PubMed Web of Science ®Google Scholar
• HalfordZ, AndersonMK, ClarkMD. Enfortumab vedotin-ejfv: a first-in-class anti-nectin-4 antibody-drug conjugate for the management of urothelial carcinoma. Ann Pharmacother. 2020;106002802096040. doi:10.1177/1060028020960402
   Web of Science ®Google Scholar