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
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. This subgroup analysis was conducted to further analyze...
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| Published in: | Cancer medicine (Malden, MA) Vol. 12; no. 3; pp. 2761 - 2771 |
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| Main Authors: | , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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United States
John Wiley & Sons, Inc
01.02.2023
John Wiley and Sons Inc Wiley |
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| ISSN: | 2045-7634, 2045-7634 |
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| Abstract | 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. This subgroup analysis was conducted to further analyze the efficacy and safety in a Japanese population.
Methods
In the open‐label, phase 3 EV‐301 trial, patients with la/mUC were randomized 1:1 to EV 1.25 mg/kg on Days 1, 8, and 15 for 28‐day cycles or investigator‐preselected standard chemotherapy (SC; docetaxel or paclitaxel for patients in Japan) on Day 1 of each 21‐day cycle. Primary endpoint was OS and secondary efficacy endpoints included progression‐free survival (PFS) and overall response rate (ORR). Safety/tolerability was also evaluated.
Results
As of the July 15, 2020 cut‐off date for the interim analysis, the Japanese subgroup included 86 patients (EV: n = 36; SC: n = 50). Median OS was 15.18 months for EV and 10.55 months for SC (HR: 0.437 [95% CI: 0.209, 0.914]). Median PFS was 6.47 months for EV and 5.39 months for SC (HR: 0.464 [95% CI: 0.258, 0.835]). Confirmed ORR was 34.4% for EV and 21.3% for SC. A higher proportion of patients receiving SC versus EV had treatment‐related adverse events (TRAEs; 97.9% vs. 91.7%, respectively), including grade ≥ 3 TRAEs (75.0% vs. 63.9%).
Conclusions
This subgroup analysis confirmed that EV, with consistent efficacy and safety/tolerability in the EV‐301 Japanese subgroup and overall study population, represents an important treatment option for previously treated patients with la/mUC.
In the global, open‐label, phase 3 EV‐301 trial, enfortumab vedotin (EV) demonstrated clinically significant overall survival (OS) benefit compared with standard chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma. This subgroup analysis of EV‐301 Japanese patients confirmed that EV demonstrated an OS benefit and no new safety signals identified in the Japanese subpopulation, consistent with the efficacy and safety/tolerability in the EV‐301 overall study population. |
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| AbstractList | 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. This subgroup analysis was conducted to further analyze the efficacy and safety in a Japanese population.
Methods
In the open‐label, phase 3 EV‐301 trial, patients with la/mUC were randomized 1:1 to EV 1.25 mg/kg on Days 1, 8, and 15 for 28‐day cycles or investigator‐preselected standard chemotherapy (SC; docetaxel or paclitaxel for patients in Japan) on Day 1 of each 21‐day cycle. Primary endpoint was OS and secondary efficacy endpoints included progression‐free survival (PFS) and overall response rate (ORR). Safety/tolerability was also evaluated.
Results
As of the July 15, 2020 cut‐off date for the interim analysis, the Japanese subgroup included 86 patients (EV: n = 36; SC: n = 50). Median OS was 15.18 months for EV and 10.55 months for SC (HR: 0.437 [95% CI: 0.209, 0.914]). Median PFS was 6.47 months for EV and 5.39 months for SC (HR: 0.464 [95% CI: 0.258, 0.835]). Confirmed ORR was 34.4% for EV and 21.3% for SC. A higher proportion of patients receiving SC versus EV had treatment‐related adverse events (TRAEs; 97.9% vs. 91.7%, respectively), including grade ≥ 3 TRAEs (75.0% vs. 63.9%).
Conclusions
This subgroup analysis confirmed that EV, with consistent efficacy and safety/tolerability in the EV‐301 Japanese subgroup and overall study population, represents an important treatment option for previously treated patients with la/mUC.
In the global, open‐label, phase 3 EV‐301 trial, enfortumab vedotin (EV) demonstrated clinically significant overall survival (OS) benefit compared with standard chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma. This subgroup analysis of EV‐301 Japanese patients confirmed that EV demonstrated an OS benefit and no new safety signals identified in the Japanese subpopulation, consistent with the efficacy and safety/tolerability in the EV‐301 overall study population. 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. This subgroup analysis was conducted to further analyze the efficacy and safety in a Japanese population. In the open-label, phase 3 EV-301 trial, patients with la/mUC were randomized 1:1 to EV 1.25 mg/kg on Days 1, 8, and 15 for 28-day cycles or investigator-preselected standard chemotherapy (SC; docetaxel or paclitaxel for patients in Japan) on Day 1 of each 21-day cycle. Primary endpoint was OS and secondary efficacy endpoints included progression-free survival (PFS) and overall response rate (ORR). Safety/tolerability was also evaluated. As of the July 15, 2020 cut-off date for the interim analysis, the Japanese subgroup included 86 patients (EV: n = 36; SC: n = 50). Median OS was 15.18 months for EV and 10.55 months for SC (HR: 0.437 [95% CI: 0.209, 0.914]). Median PFS was 6.47 months for EV and 5.39 months for SC (HR: 0.464 [95% CI: 0.258, 0.835]). Confirmed ORR was 34.4% for EV and 21.3% for SC. A higher proportion of patients receiving SC versus EV had treatment-related adverse events (TRAEs; 97.9% vs. 91.7%, respectively), including grade ≥ 3 TRAEs (75.0% vs. 63.9%). This subgroup analysis confirmed that EV, with consistent efficacy and safety/tolerability in the EV-301 Japanese subgroup and overall study population, represents an important treatment option for previously treated patients with la/mUC. In the global, open‐label, phase 3 EV‐301 trial, enfortumab vedotin (EV) demonstrated clinically significant overall survival (OS) benefit compared with standard chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma. This subgroup analysis of EV‐301 Japanese patients confirmed that EV demonstrated an OS benefit and no new safety signals identified in the Japanese subpopulation, consistent with the efficacy and safety/tolerability in the EV‐301 overall study population. Abstract 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. This subgroup analysis was conducted to further analyze the efficacy and safety in a Japanese population. Methods In the open‐label, phase 3 EV‐301 trial, patients with la/mUC were randomized 1:1 to EV 1.25 mg/kg on Days 1, 8, and 15 for 28‐day cycles or investigator‐preselected standard chemotherapy (SC; docetaxel or paclitaxel for patients in Japan) on Day 1 of each 21‐day cycle. Primary endpoint was OS and secondary efficacy endpoints included progression‐free survival (PFS) and overall response rate (ORR). Safety/tolerability was also evaluated. Results As of the July 15, 2020 cut‐off date for the interim analysis, the Japanese subgroup included 86 patients (EV: n = 36; SC: n = 50). Median OS was 15.18 months for EV and 10.55 months for SC (HR: 0.437 [95% CI: 0.209, 0.914]). Median PFS was 6.47 months for EV and 5.39 months for SC (HR: 0.464 [95% CI: 0.258, 0.835]). Confirmed ORR was 34.4% for EV and 21.3% for SC. A higher proportion of patients receiving SC versus EV had treatment‐related adverse events (TRAEs; 97.9% vs. 91.7%, respectively), including grade ≥ 3 TRAEs (75.0% vs. 63.9%). Conclusions This subgroup analysis confirmed that EV, with consistent efficacy and safety/tolerability in the EV‐301 Japanese subgroup and overall study population, represents an important treatment option for previously treated patients with la/mUC. 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. This subgroup analysis was conducted to further analyze the efficacy and safety in a Japanese population.BACKGROUNDEnfortumab 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. This subgroup analysis was conducted to further analyze the efficacy and safety in a Japanese population.In the open-label, phase 3 EV-301 trial, patients with la/mUC were randomized 1:1 to EV 1.25 mg/kg on Days 1, 8, and 15 for 28-day cycles or investigator-preselected standard chemotherapy (SC; docetaxel or paclitaxel for patients in Japan) on Day 1 of each 21-day cycle. Primary endpoint was OS and secondary efficacy endpoints included progression-free survival (PFS) and overall response rate (ORR). Safety/tolerability was also evaluated.METHODSIn the open-label, phase 3 EV-301 trial, patients with la/mUC were randomized 1:1 to EV 1.25 mg/kg on Days 1, 8, and 15 for 28-day cycles or investigator-preselected standard chemotherapy (SC; docetaxel or paclitaxel for patients in Japan) on Day 1 of each 21-day cycle. Primary endpoint was OS and secondary efficacy endpoints included progression-free survival (PFS) and overall response rate (ORR). Safety/tolerability was also evaluated.As of the July 15, 2020 cut-off date for the interim analysis, the Japanese subgroup included 86 patients (EV: n = 36; SC: n = 50). Median OS was 15.18 months for EV and 10.55 months for SC (HR: 0.437 [95% CI: 0.209, 0.914]). Median PFS was 6.47 months for EV and 5.39 months for SC (HR: 0.464 [95% CI: 0.258, 0.835]). Confirmed ORR was 34.4% for EV and 21.3% for SC. A higher proportion of patients receiving SC versus EV had treatment-related adverse events (TRAEs; 97.9% vs. 91.7%, respectively), including grade ≥ 3 TRAEs (75.0% vs. 63.9%).RESULTSAs of the July 15, 2020 cut-off date for the interim analysis, the Japanese subgroup included 86 patients (EV: n = 36; SC: n = 50). Median OS was 15.18 months for EV and 10.55 months for SC (HR: 0.437 [95% CI: 0.209, 0.914]). Median PFS was 6.47 months for EV and 5.39 months for SC (HR: 0.464 [95% CI: 0.258, 0.835]). Confirmed ORR was 34.4% for EV and 21.3% for SC. A higher proportion of patients receiving SC versus EV had treatment-related adverse events (TRAEs; 97.9% vs. 91.7%, respectively), including grade ≥ 3 TRAEs (75.0% vs. 63.9%).This subgroup analysis confirmed that EV, with consistent efficacy and safety/tolerability in the EV-301 Japanese subgroup and overall study population, represents an important treatment option for previously treated patients with la/mUC.CONCLUSIONSThis subgroup analysis confirmed that EV, with consistent efficacy and safety/tolerability in the EV-301 Japanese subgroup and overall study population, represents an important treatment option for previously treated patients with la/mUC. 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. This subgroup analysis was conducted to further analyze the efficacy and safety in a Japanese population. Methods In the open‐label, phase 3 EV‐301 trial, patients with la/mUC were randomized 1:1 to EV 1.25 mg/kg on Days 1, 8, and 15 for 28‐day cycles or investigator‐preselected standard chemotherapy (SC; docetaxel or paclitaxel for patients in Japan) on Day 1 of each 21‐day cycle. Primary endpoint was OS and secondary efficacy endpoints included progression‐free survival (PFS) and overall response rate (ORR). Safety/tolerability was also evaluated. Results As of the July 15, 2020 cut‐off date for the interim analysis, the Japanese subgroup included 86 patients (EV: n = 36; SC: n = 50). Median OS was 15.18 months for EV and 10.55 months for SC (HR: 0.437 [95% CI: 0.209, 0.914]). Median PFS was 6.47 months for EV and 5.39 months for SC (HR: 0.464 [95% CI: 0.258, 0.835]). Confirmed ORR was 34.4% for EV and 21.3% for SC. A higher proportion of patients receiving SC versus EV had treatment‐related adverse events (TRAEs; 97.9% vs. 91.7%, respectively), including grade ≥ 3 TRAEs (75.0% vs. 63.9%). Conclusions This subgroup analysis confirmed that EV, with consistent efficacy and safety/tolerability in the EV‐301 Japanese subgroup and overall study population, represents an important treatment option for previously treated patients with la/mUC. |
| Author | Matsumoto, Hiroaki Azuma, Haruhito Yonese, Junji Wu, Chunzhang Kojima, Takahiro Rosenberg, Jonathan E. Petrylak, Daniel P. Matsangou, Maria Yamashiro, Mayumi Matsubara, Nobuaki Powles, Thomas Campbell, Mary |
| AuthorAffiliation | 3 Department of Urology Aichi Cancer Center Nagoya Aichi Japan 1 Department of Medical Oncology National Cancer Center Hospital East Chiba Japan 8 Yale Cancer Center New Haven Connecticut USA 10 Seagen Inc. Bothell Washington USA 2 Department of Urology Cancer Institute Hospital, Japanese Foundation for Cancer Research Tokyo Japan 6 Barts Cancer Institute, CRUK Experimental Cancer Medicine Centre London UK 11 Astellas Pharma, Inc. Tokyo Japan 5 Department of Urology Yamaguchi University, School of Medicine Ube Japan 9 Astellas Pharma, Inc. Northbrook Illinois USA 4 Department of Urology Osaka Medical and Pharmaceutical University Osaka Japan 7 Department of Medicine, Division of Solid Tumor Oncology Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center New York New York USA |
| AuthorAffiliation_xml | – name: 1 Department of Medical Oncology National Cancer Center Hospital East Chiba Japan – name: 4 Department of Urology Osaka Medical and Pharmaceutical University Osaka Japan – name: 3 Department of Urology Aichi Cancer Center Nagoya Aichi Japan – name: 8 Yale Cancer Center New Haven Connecticut USA – name: 7 Department of Medicine, Division of Solid Tumor Oncology Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center New York New York USA – name: 9 Astellas Pharma, Inc. Northbrook Illinois USA – name: 2 Department of Urology Cancer Institute Hospital, Japanese Foundation for Cancer Research Tokyo Japan – name: 6 Barts Cancer Institute, CRUK Experimental Cancer Medicine Centre London UK – name: 10 Seagen Inc. Bothell Washington USA – name: 5 Department of Urology Yamaguchi University, School of Medicine Ube Japan – name: 11 Astellas Pharma, Inc. Tokyo Japan |
| Author_xml | – sequence: 1 givenname: Nobuaki orcidid: 0000-0002-9203-4245 surname: Matsubara fullname: Matsubara, Nobuaki email: nmatsuba@east.ncc.go.jp organization: National Cancer Center Hospital East – sequence: 2 givenname: Junji surname: Yonese fullname: Yonese, Junji organization: Cancer Institute Hospital, Japanese Foundation for Cancer Research – sequence: 3 givenname: Takahiro surname: Kojima fullname: Kojima, Takahiro organization: Aichi Cancer Center – sequence: 4 givenname: Haruhito surname: Azuma fullname: Azuma, Haruhito organization: Osaka Medical and Pharmaceutical University – sequence: 5 givenname: Hiroaki surname: Matsumoto fullname: Matsumoto, Hiroaki organization: Yamaguchi University, School of Medicine – sequence: 6 givenname: Thomas surname: Powles fullname: Powles, Thomas organization: Barts Cancer Institute, CRUK Experimental Cancer Medicine Centre – sequence: 7 givenname: Jonathan E. surname: Rosenberg fullname: Rosenberg, Jonathan E. organization: Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center – sequence: 8 givenname: Daniel P. surname: Petrylak fullname: Petrylak, Daniel P. organization: Yale Cancer Center – sequence: 9 givenname: Maria surname: Matsangou fullname: Matsangou, Maria organization: Astellas Pharma, Inc – sequence: 10 givenname: Chunzhang surname: Wu fullname: Wu, Chunzhang organization: Astellas Pharma, Inc – sequence: 11 givenname: Mary surname: Campbell fullname: Campbell, Mary organization: Seagen Inc – sequence: 12 givenname: Mayumi surname: Yamashiro fullname: Yamashiro, Mayumi organization: Astellas Pharma, Inc |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/36052536$$D View this record in MEDLINE/PubMed |
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| Keywords | antibody-drug conjugate urothelial carcinoma metastatic Japanese enfortumab vedotin |
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| References_xml | – volume: 48 start-page: 771 issue: 8 year: 2018 end-page: 776 article-title: Outcome and prognostic factors in metastatic urothelial carcinoma patients receiving second‐line chemotherapy: an analysis of real‐world clinical practice data in Japan publication-title: Jpn J Clin Oncol – volume: 14 start-page: 347 issue: 4 year: 2018 end-page: 352 article-title: Preliminary efficacy and tolerability of chemohormonal therapy in metastatic hormone‐naive prostate cancer: the first real‐life experience in Asia publication-title: Asia Pac J Clin Oncol – volume: 35 start-page: 38 e1 issue: 2 year: 2017 end-page: 38 e8 article-title: Outcome of metastatic urothelial carcinoma treated by systemic chemotherapy: prognostic factors based on real‐world clinical practice in Japan publication-title: Urol Oncol – volume: 6 start-page: 4 issue: 1 year: 2018 article-title: Biomarkers of immunotherapy in urothelial and renal cell carcinoma: PD‐L1, tumor mutational burden, and beyond 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double‐blind, placebo‐controlled, phase 3 study publication-title: Jpn J Clin Oncol – volume: 71 start-page: 209 issue: 3 year: 2021 end-page: 249 article-title: Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries publication-title: CA Cancer J Clin – volume: 39 start-page: 425 issue: 6_suppl year: 2021 article-title: Avelumab (Ave) first‐line (1L) maintenance plus best supportive care (BSC) versus BSC alone for advanced urothelial carcinoma (UC): JAVELIN bladder 100 Japanese subgroup analysis publication-title: J Clin Oncol – volume: 383 start-page: 1218 issue: 13 year: 2020 end-page: 1230 article-title: Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma publication-title: N Engl J Med – volume: 384 start-page: 1125 issue: 12 year: 2021 end-page: 1135 article-title: Enfortumab vedotin in previously treated advanced urothelial carcinoma publication-title: N Engl J Med – volume: 18 start-page: 351 issue: 5 year: 2020 end-page: 360 article-title: Programmed death 1 and programmed death ligand 1 inhibitors in advanced and recurrent urothelial carcinoma: meta‐analysis of aingle‐agent studies publication-title: Clin Genitourin Cancer – volume: 12 start-page: 300 issue: 5 year: 2020 end-page: 306 article-title: Treating Japanese patients with pembrolizumab for platinum‐refractory advanced urothelial carcinoma in real‐world clinical practice publication-title: J Clin Med Res – volume: 47 start-page: 284 issue: 3 year: 2017 end-page: 285 article-title: Incidence rate for bladder cancer in Japanese in Japan and in the United States from the cancer incidence in five continents publication-title: Jpn J Clin Oncol – volume: 27 start-page: 362 issue: 5 year: 2020 end-page: 368 article-title: Clinical practice guidelines for bladder cancer 2019 edition by the Japanese Urological Association: revision working position paper publication-title: Int J Urol – volume: 38 start-page: 1056 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Enfortumab vedotin (EV) is an antibody‐drug conjugate showing significant overall survival (OS) benefit versus chemotherapy for patients with... Enfortumab vedotin (EV) is an antibody-drug conjugate showing significant overall survival (OS) benefit versus chemotherapy for patients with previously... Background Enfortumab vedotin (EV) is an antibody‐drug conjugate showing significant overall survival (OS) benefit versus chemotherapy for patients with... In the global, open‐label, phase 3 EV‐301 trial, enfortumab vedotin (EV) demonstrated clinically significant overall survival (OS) benefit compared with... Abstract Background Enfortumab vedotin (EV) is an antibody‐drug conjugate showing significant overall survival (OS) benefit versus chemotherapy for patients... |
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| SubjectTerms | Antibodies, Monoclonal, Humanized - therapeutic use antibody‐drug conjugate Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bladder cancer Cancer therapies Carcinoma, Transitional Cell - pathology Cell cycle Chemotherapy Diabetes Drug dosages East Asian People enfortumab vedotin FDA approval Humans Japanese Metastases Metastasis metastatic Monoclonal antibodies Paclitaxel Patients Population Population studies Safety Scintigraphy Survival Targeted cancer therapy Urinary Bladder Neoplasms - pathology Urothelial carcinoma |
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| Title | 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 |
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