Pulse Brain · Growing Health Evidence Index
Tier 3 — Observational / field trialPeer-reviewed

Atezolizumab monotherapy for metastatic urothelial carcinoma: final analysis from the phase II IMvigor210 trial

J. E. Rosenberg, M.D. Galsky, Thomas Powles, Daniel P. Petrylak, Joaquim Bellmunt, Y. Loriot, A. Necchi, Jean Hoffman‐Censits, José Luis Perez‐Gracia, Michiel S. van der Heijden, Robert Dreicer, Ignacio Durán, D Castellano, Alexandra Drakaki, Margitta Retz, Srikala S. Sridhar, P. Grivas, Evan Y. Yu, Peter H. O’Donnell, H.A. Burris, S. Mariathasan, Yi Shi, Erik T. Goluboff, Dean F. Bajorin

ESMO Open · 2024

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Summary

This final analysis of the IMvigor210 trial demonstrates that atezolizumab monotherapy (anti-PD-L1) achieved clinically meaningful but modest efficacy in metastatic urothelial carcinoma, with response rates of 23.5% in treatment-naïve patients ineligible for cisplatin and 16.5–19.7% in previously treated patients, and durable responses in a subset of patients with higher PD-L1 expression. Median overall survival was 16.3 months in the untreated cohort and 7.9 months in the previously treated cohort, with manageable safety profile (21.8% and 18.7% grade 3/4 adverse events respectively) and no new safety signals during extended follow-up.

UK applicability

This trial enrolled international patients with metastatic urothelial carcinoma and is directly relevant to UK oncology practice. The findings support consideration of atezolizumab as a treatment option for eligible patients with metastatic UC, particularly those ineligible for cisplatin-based chemotherapy, though modest response rates suggest patient selection and biomarker-driven approaches remain important.

Key measures

Objective response rate (ORR) per RECIST 1.1 and modified RECIST; median overall survival (OS); grade 3/4 treatment-related adverse events; efficacy stratified by PD-L1 tumour-infiltrating immune cell (IC) status

Outcomes reported

The study reported objective response rates (ORR), overall survival (OS), and treatment-related adverse events in patients with metastatic urothelial carcinoma receiving atezolizumab monotherapy across two cohorts (treatment-naïve ineligible for cisplatin and previously platinum-treated patients).

Theme
General food systems / other
Subject
Other / interdisciplinary
Study type
Research
Study design
Phase II single-arm trial with long-term follow-up
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/j.esmoop.2024.103972
Catalogue ID
SNmoh0dt3x-0xa3m0

Topic tags

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