Clinical Trials

Date: 2017-05-10

Type of information: Results

phase: 3

Announcement: 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)

Latest news:

  • • On May 10, 2017, Chugai Pharmaceutical announced that atezolizumab did not meet its primary endpoint of statistically meaningful improvement in overall survival (OS) compared to chemotherapy in the phase III IMvigor211 study in patients with locally advanced or metastatic urothelial carcinoma (mUC) whose disease progressed during or following a platinum-containing chemotherapy. The safety profile of atezolizumab in this study was consistent with those observed in previous studies, with no new or unexpected adverse events. The results observed in people treated with atezolizumab in IMvigor 211 were generally consistent with those observed in a similar group of people in the Phase II IMvigor 210 study. However, the chemotherapy arm results were better than study design assumptions. The data of the study will be presented in the future.

Is general: Yes