EU CHMP recommends Tecentriq (atezolizumab) as monotherapy to treat metastatic urothelial carcinoma (bladder cancer)- Roche

The CHMP has adopted a positive opinion for the use of Tecentriq (atezolizumab) as a monotherapy for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) who have been previously treated with a platinum based chemotherapy or who are considered ineligible for cisplatin chemotherapy. This positive opinion is based on results from the randomised Phase III IMvigor211 study and cohorts 1 and 2 from the single-arm Phase II IMvigor210 study.

Comment: IMvigor211 is a Phase III study of atezolizumab compared to chemotherapy in people with advanced bladder cancer who were previously treated with a platinum-based chemotherapy. Overall response rates (ORR) were similar to those previously reported in the phase II IMvigor210 study and similar between the two study arms. The median duration of response (mDOR), a secondary endpoint, for those receiving atezolizumab was 21.7 months (95% CI: 13.0, 21.7) in the overall study population, compared to 7.4 months (95% CI: 6.1, 10.3) for those receiving chemotherapy. At the time of data cutoff, the majority (63%) of people who responded to treatment with atezolizumab continued to respond, compared to 21% of people treated with chemotherapy.