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Drug Profile

Enfortumab vedotin-ejfv for the treatment of advanced urothelial carcinoma

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Pages 449-455 | Received 02 Mar 2022, Accepted 20 Apr 2022, Published online: 26 Apr 2022

References

  • Cancer Stat Facts: Bladder Cancer. Surveillance, epidemiology, and end results program. Bethesda, MD: National Cancer Institute 2022 .
  • Bladder cancer in: society AC. editor. 2021.
  • Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68:394–424.
  • Bassi P, Ferrante GD, Piazza N, et al. Prognostic factors of outcome after radical cystectomy for bladder cancer: a retrospective study of a homogeneous patient cohort. J Urol. 1999;161:1494–1497.
  • Grossman HB, Natale RB, Tangen CM, et al. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med. 2003;349:859–866.
  • Mari A, Campi R, Tellini R, et al. Patterns and predictors of recurrence after open radical cystectomy for bladder cancer: a comprehensive review of the literature. World J Urol. 2018;36:157–170.
  • Powles T, Park SH, Voog E, et al. Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma. N Engl J Med. 2020;383:1218–1230.
  • Knowles MA, Hurst CD. Molecular biology of bladder cancer: new insights into pathogenesis and clinical diversity. Nat Rev Cancer. 2015;15:25–41.
  • Loriot Y, Necchi A, Park SH, et al. Erdafitinib in locally advanced or metastatic urothelial carcinoma. N Engl J Med. 2019;381:338–348.
  • 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;76:3003–3013.
  • Klute K, Nackos E, Tasaki S, et al. Microtubule inhibitor-based antibody-drug conjugates for cancer therapy. Onco Targets Ther. 2014;7:2227.
  • Masters JC, Nickens DJ, Xuan D, et al. Clinical toxicity of antibody drug conjugates: a meta-analysis of payloads. Invest New Drugs. 2018;36:121–135.
  • PADCEV (enfortumab vedotin-ejfv) [package insert]. Northbrook IL: Astellas Pharma US Inc; 2021 July.
  • Rosenberg J, Sridhar SS, Zhang J, 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;38:1041–1049.
  • 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. 37(29): 2592–2600. 2019.
  • Yu EY, Petrylak DP, O’Donnell PH, et al. Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2021;22:872–882.
  • Powles T, Rosenberg JE, Sonpavde GP, et al. Enfortumab Vedotin in previously treated advanced urothelial carcinoma. N Engl J Med. 2021;384:1125–1135.
  • Mamtani R, Rosenberg JE, Powles T, et al. Quality of life, functioning, and symptoms in patients with previously treated locally advanced or metastatic urothelial carcinoma from EV-301: a randomized phase 3 trial of enfortumab vedotin versus chemotherapy. J clin oncol. 2021;39:4539.
  • Koshkin VS, Henderson N, James M, et al. Efficacy of enfortumab vedotin in advanced urothelial cancer: analysis from the Urothelial Cancer Network to Investigate Therapeutic Experiences (UNITE) study. Cancer. 2022:128(6):1194–1205.
  • Chu CE, Sjöström M, Egusa EA, et al. Heterogeneity in NECTIN4 expression across molecular subtypes of urothelial cancer mediates sensitivity to Enfortumab Vedotin. Clin Cancer Res. 2021;15:5123–5130.
  • FDA grants accelerated approval to enfortumab vedotin-ejfv for metastatic urothelial cancer. 2019.
  • FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer. 2021.
  • Nguyen MN, Reyes M, Jones SC. Postmarketing cases of Enfortumab Vedotin–associated skin reactions reported as stevens-johnson syndrome or toxic epidermal necrolysis. JAMA Dermatol. 2021;157:1237.
  • Hoimes C, Rosenberg J, Srinivas S, et al. 901O - EV-103: initial results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. Ann Oncol. 2019;30:v356.
  • Rosenberg JE, Flaig TW, Friedlander TW, et al. Study EV-103: durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. J clin oncol. 2020;38:5044.
  • Friedlander TW, Milowsky MI, Bilen MA, et al. Study EV-103: update on durability results and long term outcome of enfortumab vedotin + pembrolizumab in first line locally advanced or metastatic urothelial carcinoma (la/mUC). J clin oncol. 2021;39:4528.
  • Liu BA, Olson D, Snead K, et al. Enfortumab vedotin, an anti-Nectin-4 ADC demonstrates bystander cell killing and immunogenic cell death anti-tumor activity mechanisms of action in urothelial cancers. Cancer Res. 2020;80(16_Supplement):5581.
  • Adib E, Jain RK, Skelton WP, et al. Impact of FGFR2/3 activating genomic alterations on response to enfortumab vedotin in metastatic urothelial carcinoma (mUC). J clin oncol. 2021;39:472.
  • Chou J, Trepka K, Sjostrom M, et al. TROP2 expression across molecular subtypes of urothelial carcinoma and Enfortumab Vedotin-resistant cells. Eur Urol Oncol. 2022. https://doi.org/10.1016/j.euo.2021.11.005.
  • Petrylak DP, Flaig TW, Mar N, et al. Study EV-103 Cohort H: antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients (pts) with muscle invasive bladder cancer (MIBC) who are cisplatin-ineligible. J clin oncol. 2022;40:435.

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