Roche announced updated results from the pivotal phase II study, IMvigor 210, of the investigational cancer immunotherapy atezolizumab (MPDL3280A) in people with locally advanced or metastatic urothelial carcinoma (mUC). Median overall survival (mOS) in this heavily pre-treated population was 11.4 months [95% CI: 9.0, NE] in people with higher levels of PD-L1 expression, and 7.9 months [95% CI: 6.6, 9.3] in the overall study population. The study also showed that 84% (n=38/45) of people who responded to atezolizumab continued to respond regardless of their PD-L1 status, when the results were assessed with longer median follow-up of 11.7 months.

Roche is planning to submit these data imminently to Global health authorities and the U.S. Food and Drug Administration (FDA) under Breakthrough Therapy designation. This designation is designed to expedite the development and review of medicines that may demonstrate substantial improvement over existing therapies for serious diseases.