Pan-Asian subgroup analysis of EV-302/KEYNOTE-A39: a phase 3 study to evaluate enfortumab vedotin and pembrolizumab in patients with untreated advanced urothelial carcinoma
Issued Date
2026-01-01
Resource Type
ISSN
13419625
eISSN
14377772
Scopus ID
2-s2.0-105028164861
Pubmed ID
41563650
Journal Title
International Journal of Clinical Oncology
Rights Holder(s)
SCOPUS
Bibliographic Citation
International Journal of Clinical Oncology (2026)
Suggested Citation
Kikuchi E., Van der Heijden M.S., Valderrama B.P., Gupta S., Bedke J., Shin S.J., Li J.R., Guo J., Danchaivijitr P., Kanesvaran R., Park S.H., Su W.P., Kandori S., Bae W.K., Wong A., Gorla S., Bavle A., Yu X., Lu Y.T., Powles T. Pan-Asian subgroup analysis of EV-302/KEYNOTE-A39: a phase 3 study to evaluate enfortumab vedotin and pembrolizumab in patients with untreated advanced urothelial carcinoma. International Journal of Clinical Oncology (2026). doi:10.1007/s10147-025-02950-8 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/114349
Title
Pan-Asian subgroup analysis of EV-302/KEYNOTE-A39: a phase 3 study to evaluate enfortumab vedotin and pembrolizumab in patients with untreated advanced urothelial carcinoma
Author's Affiliation
University of Tsukuba
Pfizer Inc.
Merck & Co., Inc.
Barts and The London School of Medicine and Dentistry
Samsung Medical Center, Sungkyunkwan university
The Netherlands Cancer Institute
Hospital Universitario Virgen del Rocío
Siriraj Hospital
National Cheng Kung University College of Medicine
Veterans General Hospital-Taichung Taiwan
St. Marianna University School of Medicine
Severance Hospital
Chonnam National University Medical School
Beijing Cancer Hospital
Astellas Pharma Inc., Japan
Taussig Cancer Center
National Cancer Centre, Singapore
Klinikum Stuttgart
National University Cancer Institute
Pfizer Inc.
Merck & Co., Inc.
Barts and The London School of Medicine and Dentistry
Samsung Medical Center, Sungkyunkwan university
The Netherlands Cancer Institute
Hospital Universitario Virgen del Rocío
Siriraj Hospital
National Cheng Kung University College of Medicine
Veterans General Hospital-Taichung Taiwan
St. Marianna University School of Medicine
Severance Hospital
Chonnam National University Medical School
Beijing Cancer Hospital
Astellas Pharma Inc., Japan
Taussig Cancer Center
National Cancer Centre, Singapore
Klinikum Stuttgart
National University Cancer Institute
Corresponding Author(s)
Other Contributor(s)
Abstract
Background: In the phase 3 EV-302 study, enfortumab vedotin–pembrolizumab (EV + P) significantly prolonged overall survival (OS) and progression-free survival (PFS) versus chemotherapy in patients with untreated locally advanced/metastatic urothelial carcinoma (la/mUC). We present a post hoc analysis in a pan-Asian population. Methods: Patients from China, Japan, Singapore, South Korea, Taiwan, and Thailand received 3-week cycles of EV (1.25 mg/kg; intravenously; Days 1 and 8) plus P (200 mg; intravenously; Day 1) or chemotherapy (gemcitabine [Days 1 and 8] plus cisplatin/carboplatin [Day 1]). Primary endpoints were PFS and OS. Secondary endpoints included objective response rate (ORR) and safety. Results: Overall, 176 patients were included (EV + P, n = 94; chemotherapy, n = 82). Median follow-up was 28.9 months for EV + P recipients and 26.6 months for chemotherapy recipients. EV + P prolonged PFS and OS versus chemotherapy, reducing the risk of disease progression or death by 63% (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.24–0.57) and death by 67% (HR, 0.33; [95% CI, 0.20–0.54]), respectively. Confirmed ORR was 72.2% versus 35.0%. Grade ≥ 3 treatment-related adverse events occurred in 66.0% of EV + P recipients and 68.4% of chemotherapy recipients. Most commonly maculopapular rash (11.7%) and hyperglycemia (10.6%) for EV + P and neutropenia (25.0%), anemia (19.7%), and neutrophil count decreased (18.4%) for chemotherapy. Conclusion: EV + P demonstrated a clinically meaningful survival benefit in Asian patients with untreated la/mUC, with no new safety signals observed, consistent with the global EV-302 study. Results support guideline recommendations for EV + P as preferred first-line therapy in la/mUC. Clinical trial registration: NCT04223856 (registered January 8, 2020).