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

Enfortumab vedotin plus pembrolizumab versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (EV-302): patient-reported outcomes from an open-label, randomised, controlled, phase 3 study

Shilpa Gupta, Yohann Loriot, Michiel S. van der Heijden, Jens Bedke, Begoña P. Valderrama, Eiji Kikuchi, Aude Fléchon, Daniel P. Petrylak, Maria De Santis, Matthew D. Galsky, Jae‐Lyun Lee, Umang Swami, Srikala S. Sridhar, Ugo De Giorgi, Phoebe Wright, Vanessa Shih, Yi‐Tsung Lu, Xuesong Guan, Ryan Dillon, Aditya Shetty, Blanca Homet Moreno, Jennifer L. Beaumont, Intan Purnajo, Shauna McManus, Thomas Powles

The Lancet Oncology · 2025

Read source ↗ All evidence

Summary

EV-302 was a phase 3 randomised controlled trial comparing enfortumab vedotin plus pembrolizumab (dual immunotherapy) to chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer. This report presents patient-reported outcome data from that trial, examining quality of life and symptom burden across treatment arms. The findings appear to contribute to the evidence base on tolerability and patient experience with novel immunotherapy combinations versus conventional chemotherapy in this setting.

UK applicability

Findings are directly applicable to UK clinical practice, as immunotherapy combinations are increasingly adopted in National Health Service oncology protocols for urothelial cancer. The patient-reported outcomes data may inform shared decision-making and treatment selection in UK cancer centres.

Key measures

Patient-reported outcomes including quality of life, symptom severity, and functional assessment; comparison between combination immunotherapy and standard chemotherapy regimens

Outcomes reported

The study compared patient-reported outcomes (PROs) between enfortumab vedotin plus pembrolizumab and chemotherapy in patients with untreated locally advanced or metastatic urothelial cancer. PRO measures likely included quality of life, symptom burden, and functional status assessed via validated questionnaires.

Theme
Nutrition & health
Subject
Other / interdisciplinary
Study type
Research
Study design
RCT
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/s1470-2045(25)00158-5
Catalogue ID
SNmoh0dsav-7aopr3

Topic tags

Pulse AI · ask about this record

Dig deeper with Pulse AI.

Pulse AI has read the whole catalogue. Ask about this record, its theme, or how the findings apply to UK farming and policy — every answer cites the underlying studies.