Second-line Atezolizumab Fails To Prolong Survival in Advanced Urothelial Cancer
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 study.
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 (ClinicalTrials.gov 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 (ClinicalTrials.gov 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.
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.
- Atezolizumab for urothelial carcinoma [news release]. Silver Spring, MD: US Food and Drug Administration; May 18, 2016. https://www.fda.gov/drugs/informationondrugs/ approveddrugs/ucm501878.htm. Accessed May 11, 2017.
- Roche provides update on phase III study of TENCENTRIQ (atezolizumab) in people with previously treated advanced bladder cancer [news release]. Roche; May 10, 2017. http://www.roche.com/media/store/releases/med-cor-2017-05-10.htm. Accessed May 11, 2017.