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2019 1
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2024 2

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Filters applied: Meta-Analysis, Randomized Controlled Trial. Clear all
Page 1
Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma.
Powles T, Rosenberg JE, Sonpavde GP, Loriot Y, Durán I, Lee JL, Matsubara N, Vulsteke C, Castellano D, Wu C, Campbell M, Matsangou M, Petrylak DP. Powles T, et al. N Engl J Med. 2021 Mar 25;384(12):1125-1135. doi: 10.1056/NEJMoa2035807. Epub 2021 Feb 12. N Engl J Med. 2021. PMID: 33577729 Free PMC article. Clinical Trial.
RESULTS: A total of 608 patients underwent randomization; 301 were assigned to receive enfortumab vedotin and 307 to receive chemotherapy. As of July 15, 2020, a total of 301 deaths had occurred (134 in the enfortumab vedotin group and 167 in the chemo …
RESULTS: A total of 608 patients underwent randomization; 301 were assigned to receive enfortumab vedotin and 307 to receive c …
Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer.
Powles T, Valderrama BP, Gupta S, Bedke J, Kikuchi E, Hoffman-Censits J, Iyer G, Vulsteke C, Park SH, Shin SJ, Castellano D, Fornarini G, Li JR, Gümüş M, Mar N, Loriot Y, Fléchon A, Duran I, Drakaki A, Narayanan S, Yu X, Gorla S, Homet Moreno B, van der Heijden MS; EV-302 Trial Investigators. Powles T, et al. N Engl J Med. 2024 Mar 7;390(10):875-888. doi: 10.1056/NEJMoa2312117. N Engl J Med. 2024. PMID: 38446675 Clinical Trial.
RESULTS: A total of 886 patients underwent randomization: 442 to the enfortumab vedotin-pembrolizumab group and 444 to the chemotherapy group. ...The median number of cycles was 12 (range, 1 to 46) in the enfortumab vedotin-pembrolizumab group and 6 (r …
RESULTS: A total of 886 patients underwent randomization: 442 to the enfortumab vedotin-pembrolizumab group and 444 to the che …
Management of Dermatologic Events Associated With the Nectin-4-directed Antibody-Drug Conjugate Enfortumab Vedotin.
Lacouture ME, Patel AB, Rosenberg JE, O'Donnell PH. Lacouture ME, et al. Oncologist. 2022 Mar 11;27(3):e223-e232. doi: 10.1093/oncolo/oyac001. Oncologist. 2022. PMID: 35274723 Free PMC article. Clinical Trial.
Enfortumab vedotin is the only drug to have demonstrated survival benefit versus chemotherapy in a randomized controlled trial in patients with la/mUC previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. The development of dermatologic events
Enfortumab vedotin is the only drug to have demonstrated survival benefit versus chemotherapy in a randomized controlled trial
Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer.
O'Donnell PH, Milowsky MI, Petrylak DP, Hoimes CJ, Flaig TW, Mar N, Moon HH, Friedlander TW, McKay RR, Bilen MA, Srinivas S, Burgess EF, Ramamurthy C, George S, Geynisman DM, Bracarda S, Borchiellini D, Geoffrois L, Maroto Rey JP, Ferrario C, Carret AS, Yu Y, Guseva M, Homet Moreno B, Rosenberg JE. O'Donnell PH, et al. J Clin Oncol. 2023 Sep 1;41(25):4107-4117. doi: 10.1200/JCO.22.02887. Epub 2023 Jun 27. J Clin Oncol. 2023. PMID: 37369081 Free PMC article. Clinical Trial.
PURPOSE: Patients with locally advanced or metastatic urothelial cancer (la/mUC) who are ineligible for cisplatin-based therapy have limited first-line (1L) treatment options and significant need for improved therapies. Enfortumab vedotin (EV) and pembrolizumab (Pem …
PURPOSE: Patients with locally advanced or metastatic urothelial cancer (la/mUC) who are ineligible for cisplatin-based therapy have limited …
EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma.
Rosenberg JE, Powles T, Sonpavde GP, Loriot Y, Duran I, Lee JL, Matsubara N, Vulsteke C, Castellano D, Mamtani R, Wu C, Matsangou M, Campbell M, Petrylak DP. Rosenberg JE, et al. Ann Oncol. 2023 Nov;34(11):1047-1054. doi: 10.1016/j.annonc.2023.08.016. Epub 2023 Sep 9. Ann Oncol. 2023. PMID: 37678672 Clinical Trial.
Endpoints were overall survival (primary), progression-free survival (PFS), objective response, and safety. RESULTS: In total, 608 patients were included (enfortumab vedotin, n = 301; chemotherapy, n = 307). With a median follow-up of 23.75 months, 444 deaths had oc …
Endpoints were overall survival (primary), progression-free survival (PFS), objective response, and safety. RESULTS: In total, 608 patients …
Japanese subgroup analysis of EV-301: An open-label, randomized phase 3 study to evaluate enfortumab vedotin versus chemotherapy in subjects with previously treated locally advanced or metastatic urothelial carcinoma.
Matsubara N, Yonese J, Kojima T, Azuma H, Matsumoto H, Powles T, Rosenberg JE, Petrylak DP, Matsangou M, Wu C, Campbell M, Yamashiro M. Matsubara N, et al. Cancer Med. 2023 Feb;12(3):2761-2771. doi: 10.1002/cam4.5165. Epub 2022 Sep 2. Cancer Med. 2023. PMID: 36052536 Free PMC article. Clinical Trial.
BACKGROUND: Enfortumab vedotin (EV) is an antibody-drug conjugate showing significant overall survival (OS) benefit versus chemotherapy for patients with previously treated locally advanced or metastatic urothelial carcinoma (la/mUC) in EV-301. ...
BACKGROUND: Enfortumab vedotin (EV) is an antibody-drug conjugate showing significant overall survival (OS) benefit versus che …
A phase I study of enfortumab vedotin in Japanese patients with locally advanced or metastatic urothelial carcinoma.
Takahashi S, Uemura M, Kimura T, Kawasaki Y, Takamoto A, Yamaguchi A, Melhem-Bertrandt A, Gartner EM, Inoue T, Akazawa R, Kadokura T, Tanikawa T. Takahashi S, et al. Invest New Drugs. 2020 Aug;38(4):1056-1066. doi: 10.1007/s10637-019-00844-x. Epub 2019 Aug 14. Invest New Drugs. 2020. PMID: 31444589 Free PMC article. Clinical Trial.
Pharmacokinetic data suggest a dose-dependent increase in enfortumab vedotin maximum concentration and area under the concentration-time curve at Day 7. Enfortumab vedotin was well tolerated across both doses. Dysgeusia and alopecia (n = 9 each) were t …
Pharmacokinetic data suggest a dose-dependent increase in enfortumab vedotin maximum concentration and area under the concentr …
Efficacy and safety of enfortumab vedotin in the treatment of advanced urothelial carcinoma: a systematic review and meta-analysis.
Wang L, Shi G, Zhao G, He W, Cen Z, Xu F. Wang L, et al. Anticancer Drugs. 2023 Apr 1;34(4):473-478. doi: 10.1097/CAD.0000000000001449. Epub 2022 Nov 18. Anticancer Drugs. 2023. PMID: 36730481
This study aimed to investigate whether Enfortumab vedotin (EV) is suitable for patients with locally advanced or metastatic urothelial carcinoma and to perform a meta-analysis of its efficacy and safety. ...
This study aimed to investigate whether Enfortumab vedotin (EV) is suitable for patients with locally advanced or metastatic u …
Patient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab.
Milowsky MI, O'Donnell PH, Hoimes CJ, Petrylak DP, Flaig TW, Moon HH, Friedlander TW, Mar N, McKay RR, Srinivas S, Gravis G, Ramamurthy C, Bupathi M, Bracarda S, Wright P, Hepp Z, Carret AS, Yu Y, Dillon R, Kataria R, Beaumont JL, Purnajo I, Rosenberg JE. Milowsky MI, et al. J Clin Oncol. 2024 Apr 20;42(12):1403-1414. doi: 10.1200/JCO.23.01547. Epub 2024 Jan 12. J Clin Oncol. 2024. PMID: 38215355 Clinical Trial.
PURPOSE: Locally advanced/metastatic urothelial cancer (la/mUC) affects patients' quality of life (QOL) and functioning. We describe the impact of first-line (1L) enfortumab vedotin (EV) alone or with pembrolizumab (P) on QOL/functioning/symptoms in patients with la …
PURPOSE: Locally advanced/metastatic urothelial cancer (la/mUC) affects patients' quality of life (QOL) and functioning. We describe the imp …