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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