Inovio Pharmaceuticals, Inc. (INO) said it has entered into a clinical collaboration with Roche Group's (RHHBY) Genentech for advanced bladder cancer.
The phase 1b/2 immuno-oncology trial will evaluate Genentech's atezolizumab (Tecentriq) in combination with Inovio's INO-5401, a T cell activating immunotherapy encoding multiple antigens, and INO-9012, an immune activator encoding IL-12.
The multi-center open-label trial will be managed by Inovio, while Genentech will supply atezolizumab.
The trial, anticipated to start in 2017, is designed to evaluate the safety, immune response and clinical efficacy of the combination therapy in approximately 80 patients with advanced bladder cancer, specifically advanced unresectable or metastatic urothelial carcinoma or UC, the most common type of bladder cancer.
Thus, the study will evaluate potential benefit of a checkpoint inhibitor combined with a DNA-based immunotherapeutic and T-cell activator within a bladder cancer patient population with very limited treatment options and poor outcomes.
The prognosis for patients with advanced unresectable or metastatic UC is poor, with limited treatment options. It is a disease that has seen no major advances for more than 30 years until the approvals of checkpoint inhibitors.
Expected survival is generally less than 12 months. In the U.S., five-year survival of patients with distant metastasis is 5 percent. An estimated 79,000 new cases of urinary bladder cancer are expected in 2017 in the U.S.
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