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Atezolizumab
Source: Bladder Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 2, 2025 · Captured 2026-09-09.
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Atezolizumab is a humanized monoclonal antibody that binds to PD-L1 and prevents it from binding to its receptors, PD-1 or B7-1. Atezolizumab was voluntarily withdrawn in 2022 as a first-line treatment option for locally advanced or metastatic urothelial cancer. The withdrawal was based on the results of the randomized IMvigor130 trial (NCT02807636) which showed no significant difference in OS. No survival improvement was seen in two analyses: atezolizumab plus platinum-based chemotherapy (group A) versus placebo plus platinum-based chemotherapy (group C),[60][Level of evidence A1] and atezolizumab monotherapy (group B) versus group C.[61][Level of evidence A1]
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The trials below examined the use of atezolizumab as a first-line therapy in cisplatin-eligible patients.
Evidence (atezolizumab):
A multicenter single-arm trial (NCT0108652) included 315 cisplatin-ineligible patients or patients who were previously treated with platinum-based chemotherapy and who had inoperable locally advanced or metastatic urothelial carcinoma. Patients received atezolizumab (1,200 mg IV every 21 days).[56][Level of evidence C2]
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A multicenter single-arm trial (NCT0108652) included 315 cisplatin-ineligible patients or patients who were previously treated with platinum-based chemotherapy and who had inoperable locally advanced or metastatic urothelial carcinoma. Patients received atezolizumab (1,200 mg IV every 21 days).[56][Level of evidence C2]
The overall response rate was 15%.
A multicenter single-arm trial (NCT0108652) included 315 cisplatin-ineligible patients or patients who were previously treated with platinum-based chemotherapy and who had inoperable locally advanced or metastatic urothelial carcinoma. Patients received atezolizumab (1,200 mg IV every 21 days).[56][Level of evidence C2]
With a median follow-up of 11.7 months, 38 of 45 responders (84%) had an ongoing response.
A multicenter single-arm trial (NCT0108652) included 315 cisplatin-ineligible patients or patients who were previously treated with platinum-based chemotherapy and who had inoperable locally advanced or metastatic urothelial carcinoma. Patients received atezolizumab (1,200 mg IV every 21 days).[56][Level of evidence C2]
The response rate was 27% in patients with PD-L1 expression of at least 5%, 10% in those with PD-L1 expression of 1% to 5%, and 8% in those with PD-L1 expression of less than 1%.
A multicenter single-arm trial (NCT0108652) included 315 cisplatin-ineligible patients or patients who were previously treated with platinum-based chemotherapy and who had inoperable locally advanced or metastatic urothelial carcinoma. Patients received atezolizumab (1,200 mg IV every 21 days).[56][Level of evidence C2]
Grade 3 to 4 adverse events were reported in 16% of patients, and high-grade, immune-related adverse events were reported in 5% of patients.
Similarly, a study (NCT02108652) of 123 previously untreated patients with cisplatin-ineligible, locally advanced metastatic urothelial carcinoma who were treated with atezolizumab reported that at a median follow-up of 17.2 months, the objective response rate was 23%, and 9% had complete responses.[57][Level of evidence C2]
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Similarly, a study (NCT02108652) of 123 previously untreated patients with cisplatin-ineligible, locally advanced metastatic urothelial carcinoma who were treated with atezolizumab reported that at a median follow-up of 17.2 months, the objective response rate was 23%, and 9% had complete responses.[57][Level of evidence C2]
Of the 27 responses, 19 were ongoing at the time of data analysis. Median OS was 15.9 months.
Similarly, a study (NCT02108652) of 123 previously untreated patients with cisplatin-ineligible, locally advanced metastatic urothelial carcinoma who were treated with atezolizumab reported that at a median follow-up of 17.2 months, the objective response rate was 23%, and 9% had complete responses.[57][Level of evidence C2]
High-grade adverse events were reported in 16% of patients, 8% of patients discontinued treatment because of the adverse events, and there was one treatment-related death.
Studies cited in this source section
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Preserved source evidence · Not medical advice