FAZ053 (anti-PD-L1) is an investigational immuno-oncology treatment being developed by Novartis for patients with advanced cancers.

It is a monoclonal antibody directed against a protein called programmed cell death-1 ligand 1 (PD-L1).

How FAZ053 works

As a type of immunotherapy, FAZ053 activates the body’s own immune system to recognize and fight cancer cells.

PD-L1 is a protein produced by healthy cells. It binds to the PD-1 receptor found on the surface of immune cells called T-cells to suppress them. This is known as an immune checkpoint and is a mechanism that ensures immune cells do not mistakenly attack healthy cells

However, many human cancer cells types also can produce PD-L1 and therefore evade being recognized by the immune system.

FAZ053 functions by binding to PD-L1 on tumor cells, preventing it from binding to the PD-1 receptor on T-cells. As such, it functions as an immune checkpoint inhibitor. By inhibiting this interaction, FAZ053 enhances the activation of T-cell-mediated anti-tumor response and renders cancer cells less able to evade that response. This is expected to result in a reduction in tumor growth and size.

FAZ053 in clinical trials

FAZ053 is being evaluated in a Phase1 clinical trial (NCT02936102) to assess its safety, tolerability, pharmacokinetics (movement in the body), pharmacodynamics (effect on the body), and antitumor activity as a single agent and in combination with PDR001, another investigational immunotherapy by Novartis, in adult patients with advanced cancers.

The open-label, multi-center study was designed with a dose escalation part of FAZ053 as a single agent and in combination with PDR001, followed by a dose expansion part of FAZ053 as a single agent and in combination with PDR001.

FAZ053 initially will be dosed every three weeks and a regime dose of every six weeks also may be evaluated at the same time.

Patients may continue the treatment with FAZ053 as a single agent or in combination with PDR001 until they experience unacceptable toxicity events and/or their disease progresses.

The trial is enrolling 315 patients in the U.S., Canada, Japan, Singapore, and Spain. The study is estimated to be completed by October 2019.

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Immuno-Oncology News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

Inês Martins holds a BSc in Cell and Molecular Biology from Universidade Nova de Lisboa and is currently finishing her PhD in Biomedical Sciences at Universidade de Lisboa. Her work has been focused on blood vessels and their role in both hematopoiesis and cancer development.
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Inês Martins holds a BSc in Cell and Molecular Biology from Universidade Nova de Lisboa and is currently finishing her PhD in Biomedical Sciences at Universidade de Lisboa. Her work has been focused on blood vessels and their role in both hematopoiesis and cancer development.