Pulse Brain · Growing Health Evidence Index
Tier 2 — RCT / large cohortPeer-reviewed

Exploratory subgroup analyses of EV-302: a phase III global study to evaluate enfortumab vedotin in combination with pembrolizumab versus chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma

Michiel S. van der Heijden, Thomas Powles, Shilpa Gupta, Y. Loriot, Matt D. Galsky, Begoña P. Valderrama, S.S. Sridhar, Evan Y. Yu, Gopa Iyer, Eiji Kikuchi, D Castellano, Jean Hoffman‐Censits, Alexandra Drakaki, Nataliya Mar, J.P. Maroto Rey, Christof Vulsteke, Waddah Arafat, I. Duran, Nancy A. Dawson, Umang Swami, Seema Rao Gorla, Blanca Homet Moreno, Xuesong Yu, Yingdong Lu, Jens Bedke

ESMO Open · 2025

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Summary

This paper reports exploratory subgroup analyses from the EV-302 phase III trial, which compared enfortumab vedotin plus pembrolizumab (EV+P) with platinum-based chemotherapy in 886 previously untreated patients with locally advanced or metastatic urothelial cancer. EV+P demonstrated consistent OS, PFS, and response rate benefits across all prespecified subgroups, including those with liver metastases, visceral metastases, and lymph node-only disease, mirroring the favourable intent-to-treat population outcomes reported previously.

UK applicability

These findings are relevant to UK oncology practice and NHS treatment guidelines for urothelial cancer, as they support EV+P as a potential standard-of-care first-line option across diverse patient populations. Adoption would require consideration of cost-effectiveness, manufacturing capacity, and integration with existing NHS cancer pathways.

Key measures

Progression-free survival (PFS), overall survival (OS), confirmed objective response rate, stratified by cisplatin eligibility status, presence/absence of liver metastases, and metastatic disease sites

Outcomes reported

The study evaluated progression-free survival (PFS), overall survival (OS), and confirmed objective response rates in patients with previously untreated locally advanced or metastatic urothelial carcinoma across prespecified subgroups defined by cisplatin eligibility, liver metastasis presence, and metastatic disease sites.

Theme
General food systems / other
Subject
Other / interdisciplinary
Study type
Research
Study design
Phase III RCT with prespecified subgroup analyses
Source type
Peer-reviewed study
Status
Published
Geography
Global
System type
Human clinical
DOI
10.1016/j.esmoop.2025.105544
Catalogue ID
SNmoh0dsav-liaq4m

Topic tags

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