What question did this study set out to answer?

Evaluate the efficacy, clinical safety, and biomarker predictors of atezolizumab in patients with locally advanced or metastatic urothelial carcinoma progressing after platinum-based chemotherapy.

September 21, 2026The LancetOpen Access

Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial

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Authors

JRJonathan E. RosenbergMemorial Sloan Kettering Cancer Center JHJean Hoffman‐CensitsSidney Kimmel Comprehensive Cancer Center TPTom PowlesQueen Mary University of London

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Overview

Phase 2 trial demonstrates durable tumor responses with atezolizumab in platinum-refractory metastatic urothelial carcinoma, suggesting a viable immunotherapy option.

Key Points

Evaluate the efficacy, clinical safety, and biomarker predictors of atezolizumab in patients with locally advanced or metastatic urothelial carcinoma progressing after platinum-based chemotherapy.
Conducted a multicenter, single-arm phase 2 trial enrolling 310 patients treated with atezolizumab at 1200 mg intravenously every 3 weeks.
Assessed PD-L1 expression on tumor-infiltrating immune cells (IC) prospectively by immunohistochemistry, testing co-primary endpoints of objective response rate by RECIST v1.1 and immune-modified RECIST against a 10% historical control.
Performed exploratory biomarker analyses evaluating associations between clinical outcomes and TCGA molecular subtypes, CD8+ T cell infiltration, and tumor mutation load.
Independent review confirmed objective response rates of 26% (95% CI 18 to 36) in the IC2/3 group, 18% (95% CI 13 to 24) in the IC1/2/3 group, and 15% (95% CI 11 to 19) across all patients.
At a median follow-up of 11.7 months, 84% of responders had ongoing responses (median duration not reached), with median overall survival of 11.4 months (95% CI 9.0 to not estimable) in IC2/3 and 7.9 months (95% CI 6.6 to 9.3) overall.
Grade 3–4 treatment-related adverse events occurred in 16% of patients and grade 3–4 immune-mediated events occurred in 5%, while TCGA subtypes and mutation load independently predicted response.

Cite This Study

Rosenberg et al. (2016) studied this question.

synapsesocial.com/papers/6ab0f5e8a27b87cbace462c5 https://doi.org/10.1016/s0140-6736(16)00561-4

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September 21, 2026The LancetOpen Access

Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial

View Full Paper

Ask AI

Bookmark

Authors

JRJonathan E. RosenbergMemorial Sloan Kettering Cancer Center JHJean Hoffman‐CensitsSidney Kimmel Comprehensive Cancer Center TPTom PowlesQueen Mary University of London

Discussion

Member takes

Overview

Phase 2 trial demonstrates durable tumor responses with atezolizumab in platinum-refractory metastatic urothelial carcinoma, suggesting a viable immunotherapy option.

Key Points

Evaluate the efficacy, clinical safety, and biomarker predictors of atezolizumab in patients with locally advanced or metastatic urothelial carcinoma progressing after platinum-based chemotherapy.
Conducted a multicenter, single-arm phase 2 trial enrolling 310 patients treated with atezolizumab at 1200 mg intravenously every 3 weeks.
Assessed PD-L1 expression on tumor-infiltrating immune cells (IC) prospectively by immunohistochemistry, testing co-primary endpoints of objective response rate by RECIST v1.1 and immune-modified RECIST against a 10% historical control.
Performed exploratory biomarker analyses evaluating associations between clinical outcomes and TCGA molecular subtypes, CD8+ T cell infiltration, and tumor mutation load.
Independent review confirmed objective response rates of 26% (95% CI 18 to 36) in the IC2/3 group, 18% (95% CI 13 to 24) in the IC1/2/3 group, and 15% (95% CI 11 to 19) across all patients.
At a median follow-up of 11.7 months, 84% of responders had ongoing responses (median duration not reached), with median overall survival of 11.4 months (95% CI 9.0 to not estimable) in IC2/3 and 7.9 months (95% CI 6.6 to 9.3) overall.
Grade 3–4 treatment-related adverse events occurred in 16% of patients and grade 3–4 immune-mediated events occurred in 5%, while TCGA subtypes and mutation load independently predicted response.

Cite This Study

Rosenberg et al. (2016) studied this question.

synapsesocial.com/papers/6ab0f5e8a27b87cbace462c5 https://doi.org/10.1016/s0140-6736(16)00561-4

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