Atezolizumab, which received accelerated approval from the US Food and Drug Administration (FDA) to treat second-line locally advanced or metastatic urothelial cancer, failed to meet its primary endpoint of overall survival compared to chemotherapy, according to results of the phase 3 IMvigor211 ( Identifier: NCT02302807) study.1,2

It’s unclear whether the FDA will revoke its May 2016 approval of atezolizumab, which was based on tumor response rate and duration of response in the phase 2 open-label IMvigor210 ( Identifiers: NCT02951767, NCT02108652) study.

When approved, the agent was the first and only anti-PD-L1 cancer immunotherapy approved by the FDA, and the first approved for advanced urothelial carcinoma in more than 30 years.

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The pivotal phase 3 IMvigor211 study was designed to support the drug’s global approval and “serve as the confirmatory study to convert the accelerated approval to full approval in the US,” Roche reported in a press release.

The study randomly assigned 931 patients who had disease progression during or following platinum-based chemotherapy, or whose disease had worsened within 12 months of receiving platinum-based neoadjuvant or adjuvant chemotherapy to treatment with atezolizumab or chemotherapy (vinflunine, paclitaxel, or docetaxel).

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Full data from IMvigor211 will be presented later this year. The phase 3 results confirmed that the safety profile of atezolizumab was consistent with that previously observed.

The FDA recently granted accelerated approval to atezolizumab as first-line therapy for patients with locally advanced or metastatic urothelial cancer ineligible for cisplatin. IMvigor130, the phase 3 pivotal study, is ongoing.


  1. Atezolizumab for urothelial carcinoma [news release]. Silver Spring, MD: US Food and Drug Administration; May 18, 2016. approveddrugs/ucm501878.htm. Accessed May 11, 2017.
  2. Roche provides update on phase III study of TENCENTRIQ (atezolizumab) in people with previously treated advanced bladder cancer [news release]. Roche; May 10, 2017. Accessed May 11, 2017.