What is the role of atezolizumab (Tecentriq) in the treatment of metastatic bladder cancer?

Updated: Feb 23, 2021
  • Author: Kara N Babaian, MD, FACS; Chief Editor: Bradley Fields Schwartz, DO, FACS  more...
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Answer

Atezolizumab (Tecentriq) is the first PD-L1 inhibitor approved for the treatment of urothelial carcinoma. In May 2016, the US Food and Drug Administration (FDA) granted accelerated approval of atezolizumab for locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or following platinum-containing chemotherapy, or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. [134] In April 2017, atezolizumab’s indication was expanded to include use as initial treatment of locally advanced or metastatic urothelial carcinoma in patients who are not eligible for cisplatin chemotherapy.

Approval of atezolizumab was based on the phase II IMvigor 210 trial (n=310), an open-label, multicenter, single-arm study with two cohorts. In the previously treated patients (cohort 2), the objective response rate (ORR) was 26% for the subgroup with the highest positivity for PD-L1, 18% for the subgroup with lower positivity, and 15% for all patients. Median overall survival was 7.9 months for all patients, 11.4 months for the highest-positivity subgroup, and 6.7 months for the lowest-positivity subgroup. Twelve-month overall survival was 36% for all patients, 48% for the high group, and 30% for the low group. [134]

In the treatment-naive patients (cohort 1), the ORR was 23.5%. Complete responses were seen in 6.7%, and partial responses were seen in 16.8%. [135]

The FDA has also approved a complementary diagnostic, the Ventana PD-L1 (SP142) assay, which can detect PD-L1 protein expression levels on tumor-infiltrating immune cells and help physicians determine which patients may derive the most benefit from treatment with atezolizumab.

In IMvigor 211, a confirmatory phase III study that compared atezolizumab with chemotherapy in patients whose bladder cancer had progressed on at least one prior platinum-containing regimen, overall survival was numerically, but not significantly, longer in the atezolizumab group than in the chemotherapy group (median 15.9 vs 8.3 months, respectively). However, the safety profile of atezolizumab was superior to that of chemotherapy, with lower rates of grade 3-4 treatment-related adverse events (20% vs 43%), and of adverse events leading to treatment discontinuation (7% vs 18%). [136]


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