Clinical Trials

Date: 2015-08-26

Type of information: Initiation of the trial

phase: 3

Announcement: initiation of the trial

Company: AstraZeneca (UK)

Product: durvalumab (MEDI4736) and tremelimumab

Action mechanism:

• monoclonal antibody/immune checkpoint inhibitor.
• Durvalumab (MEDI4736) is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. This antibody is directed against B7-H1, have been shown to block the interaction between B7-H1 and its receptors, PD-1 and CD80 (B7-1). This blockade may help to overcome the immunosuppressive effects of B7-H1 on anti-tumor T cells.
• Tremelimumab is a fully human monoclonal antibody which binds to the protein CTLA-4, expressed on the surface of activated T lymphocytes.

Disease: non-small cell lung cancer (NSCLC)

Therapeutic area: Cancer - Oncology

Country: Argentina, Brazil, Bulgaria, Chile, China, Denmark, Finland, Greece, Hong Kong, India, Israel, Japan, Republic of, Korea Malaysia, Mexico, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Sweden, Turkey, Ukraine, United Arab Emirates, UK, USA

Trial details: This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC. (NCT02542293)

Latest news: • On August 26, 2015, a Phase 3 trial sponsored by AstraZeneca was published on the NIH website ClinicalTrials.gov for durvalumab (MEDI4736) and tremelimumab and is currently recruiting participants.

Is general: Yes