Enfortumab vedotin plus pembrolizumab in untreated locally advanced or metastatic urothelial carcinoma: 2.5-year median follow-up of the phase III EV-302/KEYNOTE-A39 trial Journal Article
| Authors: | Powles, T. B.; Van der Heijden, M. S.; Loriot, Y.; Bedke, J.; Valderrama, B. P.; Iyer, G.; Kikuchi, E.; Hoffman-Censits, J.; Vulsteke, C.; Drakaki, A.; Rausch, S.; Arafat, W.; Park, S. H.; Swami, U.; Li, J. R.; Duran, I.; Gorla, S.; Homet Moreno, B.; Yu, X.; Lu, Y. T.; Gupta, S. |
| Article Title: | Enfortumab vedotin plus pembrolizumab in untreated locally advanced or metastatic urothelial carcinoma: 2.5-year median follow-up of the phase III EV-302/KEYNOTE-A39 trial |
| Abstract: | Background: At the primary analysis of the EV-302 trial, enfortumab vedotin plus pembrolizumab (EV+P) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared with chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). Patients and methods: We present an updated analysis of efficacy and safety in the overall population, with a median follow-up of 2.5 years, providing an additional year of follow-up since the primary analysis. Results: The median PFS by blinded independent central review was 12.5 months [95% confidence interval (CI) 10.4-16.6 months] for the EV+P arm and 6.3 months (95% CI 6.2-6.5 months) for the chemotherapy arm [hazard ratio (HR) 0.48, 95% CI 0.41-0.57]. The median OS was 33.8 months (95% CI 26.1-39.3 months) for the EV+P arm and 15.9 months (95% CI 13.6-18.3 months) for the chemotherapy arm (HR 0.51, 95% CI 0.43-0.61). Safety data with an additional year of follow-up were consistent with those of the primary analysis. Conclusion: The continued survival benefit with EV+P compared with chemotherapy in this updated analysis reinforces EV+P as the standard of care for the first-line treatment of patients with la/mUC. © 2025 The Authors |
| Keywords: | overall survival; progression-free survival; antibody-drug conjugate; pembrolizumab; enfortumab vedotin; ev-302 |
| Journal Title: | Annals of Oncology |
| ISSN: | 0923-7534 |
| Publisher: | Oxford University Press |
| Publication status: | Online ahead of print |
| Date Published: | 2025-01-01 |
| Online Publication Date: | 2025-01-01 |
| Language: | English |
| DOI: | 10.1016/j.annonc.2025.05.536 |
| PUBMED: | 40460988 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
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