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

Autor: Nobuaki Matsubara, Junji Yonese, Takahiro Kojima, Haruhito Azuma, Hiroaki Matsumoto, Thomas Powles, Jonathan E. Rosenberg, Daniel P. Petrylak, Maria Matsangou, Chunzhang Wu, Mary Campbell, Mayumi Yamashiro
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Cancer Medicine, Vol 12, Iss 3, Pp 2761-2771 (2023)
Druh dokumentu: article
ISSN: 2045-7634
DOI: 10.1002/cam4.5165
Popis: 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.
Databáze: Directory of Open Access Journals
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