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Drug Evaluation

Enfortumab Vedotin, a fully human monoclonal antibody against Nectin 4 conjugated to monomethyl auristatin E for metastatic urothelial Carcinoma

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Pages 821-826 | Received 16 Jul 2019, Accepted 10 Sep 2019, Published online: 17 Sep 2019

References

  • SEER Cancer Stat Facts: Bladder Cancer. National Cancer Institute. Bethesda, MD. [ cited29 Jun 2019]. Available form: https://seer.cancer.gov/statfacts/html/urinb.html
  • von der Maase H, Hansen SW, Roberts JT, et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000;18(17):3068–3077.
  • Dash A, Galsky MD, Vickers AJ, et al. Impact of renal impairment on eligibility for adjuvant cisplatin-based chemotherapy in patients with urothelial carcinoma of the bladder. Cancer. 2006;107(3):506–513.
  • De Santis M, Bellmunt J, Mead G, et al. Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer “unfit” for cisplatin-based chemotherapy: phase II–results of EORTC study 30986. J Clin Oncol. 2009;27(33):5634–5639.
  • Patel MR, Ellerton J, Infante JR, et al. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN solid tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol. 2018;19(1):51–64.
  • Powles T, Duran I, van der Heijden MS, et al. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2018;391(10122):748–757.
  • Powles T, O’Donnell PH, Massard C, et al. Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma: updated results from a phase 1/2 open-label study. JAMA Oncol. 2017;3(9):e172411.
  • Bellmunt J, de Wit R, Vaughn DJ, et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med. 2017;376(11):1015–1026.
  • Sharma P, Retz M, Siefker-Radtke A, et al. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2017;18(3):312–322.
  • Loriot Y, Necchi A, Park SH, et al. Erdafitinib in locally advanced or metastatic urothelial carcinoma. N Engl J Med. 2019;381(4):338–348.
  • Bellmunt J, Choueiri TK, Fougeray R, et al. Prognostic factors in patients with advanced transitional cell carcinoma of the urothelial tract experiencing treatment failure with platinum-containing regimens. J Clin Oncol. 2010;28(11):1850–1855.
  • Sonpavde G, Pond GR, Rosenberg JE, et al. Improved 5-factor prognostic classification of patients receiving salvage systemic therapy for advanced urothelial carcinoma. J Urol. 2016;195(2):277–282.
  • Sonpavde G, Manitz J, Gao C, et al. 5-factor prognostic model for survival of patients with metastatic urothelial carcinoma receiving three different post-platinum PD-L1 inhibitors. J Clin Oncol. 2019;37(15_suppl):4552.
  • Takai Y, Miyoshi J, Ikeda W, et al. Nectins and nectin-like molecules: roles in contact inhibition of cell movement and proliferation. Nat Rev Mol Cell Biol. 2008;9(8):603–615.
  • Rikitake Y, Takai Y. Interactions of the cell adhesion molecule nectin with transmembrane and peripheral membrane proteins for pleiotropic functions. Cell Mol Life Sci. 2008;65(2):253–263.
  • Reymond N, Fabre S, Lecocq E, et al. Nectin4/PRR4, a new afadin-associated member of the nectin family that trans-interacts with nectin1/PRR1 through V domain interaction. J Biol Chem. 2001;276(46):43205–43215.
  • Challita-Eid PM, Satpayev D, Yang P, 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(10):3003–3013.
  • Rosenberg JE, Heath EI, Van Veldhuizen PJ, et al. Anti-tumor activity, safety and pharmacokinetics (PK) of ASG-22CE (ASG-22ME; enfortumab vedotin) in a phase I dose escalation trial in patients (Pts) with metastatic urothelial cancer (mUC). J Clin Oncol. 2016;34(15_suppl):4533.
  • Han TH, Zhao B. Absorption, distribution, metabolism, and excretion considerations for the development of antibody-drug conjugates. Drug Metab Dispos. 2014;42(11):1914–1920.
  • Targeting Nectin-4 in bladder cancer. Cancer Discov. 2017;7(8):OF3.
  • Rosenberg JE, Heath E, Perez R, et al. Interim analysis of a phase I dose escalation trial of ASG-22CE (ASG-22ME; enfortumab vedotin), an antibody drug conjugate (ADC), in patients (Pts) with metastatic urothelial cancer (mUC). Ann Oncol. 2016;27(suppl_6).
  • Rosenberg JE, Heath EI, O’Donnell PH, et al. EV-201 Study: A single-arm, open-label, multicenter study of enfortumab vedotin for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor therapy. J Clin Oncol. 2018;36(15_suppl):TPS4590–TPS4590.
  • Rosenberg JE, Sridhar SS, Zhang J, et al. Mature results from EV-101: a phase I study of enfortumab vedotin in patients with metastatic urothelial cancer (mUC). J Clin Oncol. 2019;37(7_suppl):377.
  • Rosenberg JE, O’Donnell PH, Balar AV, et al. Pivotal trial of Enfortumab vedotin in urothelial carcinoma after platinum and anti-programmed death 1/programmed death ligand 1 therapy. J Clin Oncol. JCO. 2019 July;19.01140 [Epub ahead of print].
  • Petrylak D, Heath E, Sonpavde G, et al. Interim analysis of a phase I dose escalation trial of the antibody drug conjugate (ADC) AGS15E (ASG-15ME) in patients (Pts) with metastatic urothelial cancer (mUC). Ann Oncol. 2016;27(suppl_6).
  • Tagawa ST, Faltas BM, Lam ET, et al. Sacituzumab govitecan (IMMU-132) in patients with previously treated metastatic urothelial cancer (mUC): results from a phase I/II study. J Clin Oncol. 2019;37(7_suppl):354.
  • Tschui J, Vassella E, Bandi N, et al. Morphological and molecular characteristics of HER2 amplified urothelial bladder cancer. Virchows Arch. 2015;466(6):703–710.
  • Takegawa N, Nonagase Y, Yonesaka K, et al. DS-8201a, a new HER2-targeting antibody-drug conjugate incorporating a novel DNA topoisomerase I inhibitor, overcomes HER2-positive gastric cancer T-DM1 resistance. Int J Cancer. 2017;141(8):1682–1689.
  • Iwata H, Tamura K, Doi T, et al. Trastuzumab deruxtecan (DS-8201a) in subjects with HER2-expressing solid tumors: long-term results of a large phase 1 study with multiple expansion cohorts. J Clin Oncol. 2018;36(15_suppl):2501.
  • Fong D, Seeber A, Terracciano L, et al. Expression of EpCAM(MF) and EpCAM(MT) variants in human carcinomas. J Clin Pathol. 2014;67(5):408–414.
  • Kowalski M, Entwistle J, Cizeau J, et al. A phase I study of an intravesically administered immunotoxin targeting EpCAM for the treatment of nonmuscle-invasive bladder cancer in BCGrefractory and BCG-intolerant patients. Drug Des Devel Ther. 2010;4:313–320.
  • Kowalski M, Guindon J, Brazas L, et al. A phase II study of oportuzumab monatox: an immunotoxin therapy for patients with noninvasive urothelial carcinoma in situ previously treated with bacillus Calmette-Guerin. J Urol. 2012;188(5):1712–1718.

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