Roche's star immunotherapy posts positive results in bladder cancer

Roche ($RHHBY), building the case for its latest immuno-oncology treatment in a wide range of tumor types, posted positive data from a study on advanced bladder cancer that it believes will support FDA approval. In a Phase II trial on 310 heavily pretreated patients with urothelial carcinoma, Roche's atezolizumab charted a 15% overall response rate and a complete response rate of 5%. In patients with heavy expression of the protein PD-L1, which atezolizumab blocks, the overall response rate was 26%, and 11% of subjects saw their cancer disappear entirely. Roche is heralding the results as a victory in bladder cancer and plans to submit them to the FDA as soon as possible. The agency has granted atezolizumab its breakthrough therapy designation in urothelial carcinoma, which could lead to shortened approval process. Roche, like its rivals in immuno-oncology, is working through a fleet of clinical trials that mix and match so-called checkpoint inhibitors with other oncology agents, testing their products on a wide array of cancers in hopes of eventually winning broad FDA approvals. More