Date: 2016-10-09
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the European Society for Medical Oncology (ESMO) 2016 Congress
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.
- In February 2015, MPDL3280A received Breakthrough Therapy from the FDA 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 ALK-positive disease). Roche’s Biologics Licence Application (BLA) for NSCLC was granted Priority Review with an action date of 19 October 2016.
Disease: non-squamous non-small cell lung cancer (NSCLC)
Therapeutic
area: Cancer - Oncology
Country: Argentina, Austria, Brazil, Canada, Chile, Finland, France, Germany, Greece, Guatemala, Hungary, Italy, Japan, Republic of Korea, The Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russian Federation, Serbia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, UK, USA, Belgium, Mexico
Trial
details:
- OAK is a global, multicentre, open-label, randomised, controlled Phase III study that evaluated the efficacy and safety of Tecentriq® compared with docetaxel in 1,225 people with locally advanced or metastatic NSCLC whose disease had progressed following previous treatment with platinum-containing chemotherapy, with the primary analysis consisting of the first 850 randomised patients. Approximately one-quarter of patients had squamous disease (26 percent). Patients were randomised (1:1) to receive either Tecentriq® administered intravenously at 1200 mg every 3 weeks or docetaxel administered intravenously at 75 mg/m2 every 3 weeks until unacceptable toxicity or disease progression. The co-primary endpoints were overall survival (OS) in all randomised patients (ITT population) and in a PD-L1-selected subgroup in the primary analysis population. (NCT02008227)
Latest
news:
- • On October 9, 2016, Roche announced data from the positive, pivotal Phase III OAK study of Tecentriq® (atezolizumab) at the European Society of Medical Oncology (ESMO) 2016 Annual Meeting in Copenhagen, Denmark. The study showed Tecentriq® helped people live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [mOS]: 13.8 vs 9.6months; HR=0.73, 95% CI: 0.62-0.87), regardless of their levels of programmed death-ligand 1 (PD-L1) expression. The OAK study evaluated people with NSCLC whose disease had progressed on or after treatment with one or more platinum-based chemotherapy (second-line and third-line. The study enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types. Adverse events (AEs) were consistent with those observed in previous Tecentriq® studies. Full results from the OAK study have been presented by Fabrice Barlesi, Assistance Publique Hôpitaux de Marseille, Marseille, France (abstract #LBA44).
Is
general: Yes
