Date: 2015-08-17
Type of information: Results
phase: 2
Announcement: results
Company: Roche (Switzerland)
Product: MPDL3280A (atezolizumab)
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: people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expressed PD-L1 (Programmed Death Ligand-1)
Therapeutic area: Cancer - Oncology
Country: Australia, Belgium, Bosnia, Bulgaria, Canada, France, Georgia, Germany, Hong Kong, Italy, Japan, The Netherlands, Singapore, Slovenia, Spain, Switzerland, Turkey, UK, USA
Trial
details: BIRCH is an open-label, multicentre, single-arm Phase II study that evaluated the safety and efficacy of atezolizumab in 667 people with locally advanced or metastatic NSCLC whose disease expressed PD-L1. PDL1 expression was assessed on both tumour cells (TC) and tumour-infiltrating immune cells (IC) with an investigational immunohistochemistry test (IHC) being developed by Roche Diagnostics. Eligibility criteria included people whose tumours were determined to express PD-L1 with an IHC score of TC2/3 or IC2/3.
People in the study received a 1200-milligram intravenous dose of atezolizumab every 3 weeks. The primary endpoint of the study was ORR. Secondary endpoints included duration of response (DoR), overall survival (OS), progression-free survival (PFS) and safety.(NCT02031458)
Latest
news: * On August 17, 2015, Roche announced that in the large pivotal Phase II study, BIRCH, the investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1) met its primary endpoint and shrank tumours (objective response rate; ORR) in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expressed PD-L1 (Programmed Death Ligand-1). The study showed the amount of PD-L1 expressed by a person’s cancer correlated with their response to the medicine. Adverse events were consistent with what has been previously observed for atezolizumab. Earlier this year, the FDA granted atezolizumab a Breakthrough Therapy Designation for the treatment of people whose NSCLC expresses PD-L1 and who progressed during or after standard treatments (e.g. platinum-based chemotherapy and appropriate targeted therapy for EGFR mutation-positive or ALKpositive disease).
