Type of information: Results
Company: Roche (Switzerland)
Product: Tecentriq® (atezolizumab) (MPDL3280A)
Action mechanism: immunotherapy product/monoclonal antibody/immune checkpoint inhibitor. Anti-PDL1 antibody MPDL3280A is an investigational monoclonal antibody designed to make cancer cells more vulnerable to the body’s immune system by interfering with a protein called PD-L1. PD-L1 is found on the surface of cells in tumours and is believed to act as a “stop sign,” preventing the immune system from destroying cancer cells. By inhibiting PD-L1, MPDL3280A may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells. MPDL3280A is being studied in clinical trials to understand whether blocking PD-L1 will help the immune system respond to cancer.
Disease: metastatic urothelial carcinoma
Therapeutic area: Cancer - Oncology
Country: Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Republic of Korea, The Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Turkey, UK, USA
Trial details: The global phase III, multi-centre, open label, randomized controlled study designed to evaluate the safety and the efficacy of atezolizumab compared to chemotherapy* (vinflunine, paclitaxel or docetaxel) in patients with locally advanced or mUC whose disease progressed during or following platinum-containing regimen. ? The primary endpoint of this study is OS. ? Secondary endpoints include safety, overall response rate, progression free survival, and duration of response. 931 patients were randomized into groups with a one to one ratio to receive either one of the chemotherapies vinflunine (320 mg/m2) / paclitaxel (175 mg/m2) / docetaxel (75 mg/m2) or atezolizumab (1,200 mg) by intravenous injection once every three weeks. Treatment with atezolizumab was continued as long as the principal investigator determined that the patient was receiving a clinical benefit or until an unacceptable adverse event was confirmed.(NCT02302807)