Nivolumab

Nivolumab (Opdivo®) is a human monoclonal antibody directed at PD-1 receptor, a negative regulator of T-cell activity. Nivolumab potentiates T-cell responses, including anti-tumour responses

Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed death-1 (PD-1) receptor, a negative regulator of T-cell activity. Inhibiting the PD-1 receptor potentiates T cell responses.  

Mechanism of action

Nivolumab blocks interaction of the PD-1 receptor with PD-L1 and PD-L2. The PD-1 receptor is involved in the control of T-cell immune responses. Engagement of PD-1 with the ligands PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment, results in inhibition of T-cell proliferation and cytokine secretion. Via blocking interaction between the PD-1 receptor and its ligands, nivolumab potentiates T-cell responses, including anti-tumour responses.  

Clinical use

In Europe, nivolumab is indicated to treat:

  • adults with advanced melanoma, i.e. spread skin cancer or that cannot be surgically removed, alone or in combination with ipilimumab.
  • adults with non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body, in those who have previously received chemotherapy
  • adults with advanced renal cell carcinoma in those who have previously received chemotherapy
  • classical Hodgkin lymphoma that has not improved or has returned after an autologous stem cell transplant and treatment with brentuximab vedotin
  • squamous cell cancer of the head and neck (SCCHN) in patients whose cancer is progressing despite treatment with platinum-based cancer medicines
  • urothelial cancer, a cancer of the bladder and urinary tract, that has spread locally and cannot be surgically removed or has spread to other parts of the body. It is used when treatment with platinum-based cancer medicines has not worked.

Consult CHMP for details.

What can Sanquin do for you?

We have tests that:

- can measure the levels of free drug in the serum; levels of therapeutic antibodies are assessed using validated ELISAs.

- can measure the immunogenicity of vedoluzimab; human anti-human antibodies are quantified using validated antigen-binding tests (radioimmunoassay or RIA).

As we have hands-on experience in these assays, we can provide you with accurate and reproducible test results. 

Send in samples

Enquire about our validated drug level and ADA assays by emailing us at [email protected].