Enfortumab vedotin monotherapy, enfortumab vedotin plus pembrolizumab, and immune checkpoint inhibitor-based neoadjuvant therapy for muscle-invasive bladder cancer: A systematic review and meta-analysis.

Authors

Shugo Yajima, Soichiro Yoshida, Naoki Imasato, Wei Chen, Hiroshi Fukushima, Hajime Tanaka, Hitoshi Masuda, Yasuhisa Fujii

Published in

Urologic oncology. Jul 11, 2026. Epub Jul 11, 2026.

Abstract

Comparative efficacy among neoadjuvant enfortumab vedotin (EV) monotherapy, EV plus pembrolizumab (EV+P), and immune checkpoint inhibitor (ICI)-based regimens for muscle-invasive bladder cancer (MIBC) is unclear, and we aimed to compare pathological and survival outcomes among these strategies. We searched PubMed, Cochrane, Web of Science, Google Scholar, and ClinicalTrials.gov (January 2015-October 2025) for prospective Phase II or higher trials of ICI- or EV-containing neoadjuvant therapy reporting pathological complete response (pCR), per PRISMA 2020. The primary outcome was pCR (ypT0N0), analyzed by random-effects meta-analysis using generalized linear mixed models. Fifteen trials (n = 1,5451,545) were included. Pooled pCR was 57% (95% confidence interval [CI], 49%-65%) for EV+P (n = 1,545170), 37% (34%-39%; I² = 1,54533%) for ICI-based regimens (13 studies, n = 1,5451,353), and 36% (17%-59%) for EV monotherapy (n = 1,54522); EV+P had a higher pCR rate than ICI-based regimens (P < .0001). In cisplatin-ineligible patients, EV+P pCR (57%) exceeded ICI-based pCR (29%; 22%-37%). Pooled radical cystectomy completion was 89%. In EV-303, EV+P versus surgery alone yielded event-free survival hazard ratio (HR) 0.40 (0.28-0.57) and overall survival HR 0.50 (0.33-0.74); NIAGARA reported HRs of 0.68 and 0.75. HRs were not pooled given different comparators, and single-trial dominance of EV-based data limits inference. In these indirect comparisons, EV+P showed a higher observed pCR rate; combined with EV-303 EFS/OS benefits and comparable surgical completion, EV+P may be a promising perioperative option for cisplatin-ineligible MIBC.

PMID:
42436099
Bibliographic data and abstract were imported from PubMed on 12 Jul 2026.

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