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Roche's atezolizumab is poised to become a major bladder cancer therapy in the race for US Food & Drug Administration (FDA) approval, following its promising performance in recent Phase II trials, says an analyst with research and consulting firm GlobalData.
In a potential bladder cancer breakthrough, Roche announced that atezolizumab, an anti-Programmed Death-Ligand 1 (PD-L1) therapy, met its primary endpoint of objective response rate in the Phase II IMvigor 210 study. During the trial, patients with higher PD-L1 expression levels showed better responses to the drug.
According to Dr Cai Xuan, GlobalData's analyst covering oncology and hematology, this observation, along with similar results for other Programmed Cell Death Protein 1 (PD-1) inhibitors in development for various cancers, opens up a market for companion biomarker tests that can be used to identify patients who would likely benefit from PD-1/PD-L1-targeted therapies.
Dr Xuan says: "Atezolizumab's Phase II results were preceded by an encouraging Phase Ia trial, during which the drug caused tumors to shrink in 50% of patients previously treated for PD-L1-positive, metastatic urothelial bladder cancer.
"In this trial, 20% of patients made a full recovery, while 57% with the highest PD-L1 expression levels were still alive one year after treatment. The most frequently observed adverse events were fatigue, asthenia, and nausea, affecting 16%, 13% and 11% of patients, respectively."