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 Journal Article


Authors: Matsubara, N.; Yonese, J.; Kojima, T.; Azuma, H.; Matsumoto, H.; Powles, T.; Rosenberg, J. E.; Petrylak, D. P.; Matsangou, M.; Wu, C.; Campbell, M.; Yamashiro, M.
Article 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
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. © 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
Keywords: controlled study; clinical trial; antineoplastic agent; randomized controlled trial; antineoplastic combined chemotherapy protocols; pathology; bladder tumor; urinary bladder neoplasms; monoclonal antibody; urothelial carcinoma; phase 3 clinical trial; carcinoma, transitional cell; transitional cell carcinoma; japanese; metastatic; antibodies, monoclonal, humanized; antibody-drug conjugate; humans; human; enfortumab vedotin; east asian people
Journal Title: Cancer Medicine
Volume: 12
Issue: 3
ISSN: 2045-7634
Publisher: Wiley Blackwell  
Date Published: 2023-02-01
Start Page: 2761
End Page: 2771
Language: English
DOI: 10.1002/cam4.5165
PUBMED: 36052536
PROVIDER: scopus
PMCID: PMC9939146
DOI/URL:
Notes: Article -- Source: Scopus
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  1. Jonathan Eric Rosenberg
    513 Rosenberg