Roche's Investigational Immunotherapy Shrank Bladder Cancer Tumors in Pivotal Study
News Jul 14, 2015
Roche announced that in the IMvigor 210 study, the investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1) shrank tumours (objective response rate, ORR, the primary end point of this Phase II study) in people with locally advanced or metastatic urothelial bladder cancer (UBC) who had progressed on initial treatment (second-line or later). High amounts of PD-L1 (Programmed Death Ligand-1) expression by a person’s cancer correlated with increased response to the medicine. Adverse events were consistent with what has been previously observed for atezolizumab.
“We are encouraged by the number of people who responded to atezolizumab and maintained their response during the study because minimal progress has been made in advanced bladder cancer for nearly 30 years,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We plan to present results at an upcoming medical meeting and will discuss next steps with health authorities to bring a new treatment option to patients as soon as possible.”
Last year, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for atezolizumab in people whose metastatic bladder cancer expressed PD-L1. This designation is designed to expedite the development and review of medicines intended to treat serious diseases.
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
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