BLA for Advanced Bladder CA Tx Granted Priority Review
Genentech announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for atezolizumab (anti-PDL1; MPDL3280A). Atezolizumab treats patients with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.
The BLA submission is based on data from IMvigor 210, an open-label, multicenter, single-arm Phase 2 study that evaluated the safety and efficacy of atezolizumab in patients with locally advanced or mUC, regardless of PD-L1 expression. The primary endpoint was objective response rate (ORR) as assessed by an independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Analysis at 11.7 months of median follow-up demonstrated that atezolizumab shrank tumors (ORR) in 15% (95% CI: 11, 19) of patients whose disease progressed after platinum-based chemotherapy (n=310). In addition, atezolizumab shrank tumors in 26% (95% CI: 18, 36) of patients whose disease had medium and high levels of PD-L1 expression (n=100).
Genentech is also conducting an ongoing, confirmatory Phase 3 study, IMvigor 211, which comparesatezolizumab to chemotherapy in patients whose bladder cancer has progressed on at least one prior platinum-containing regimen. The FDA has set a target date of September 12, 2016 to make a decision on the BLA.
Atezolizumab is an investigational monoclonal antibody designed to bind to programmed death ligand-1 (PD-L1) and block its interactions to PD-1 and B7.1 receptors.
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