Nivolumab (Opdivo¬ģ) - Therapeutic Drug Monitoring (TDM)

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. Via blocking interaction between the PD-1 receptor and its ligands, nivolumab potentiates T-cell responses, including anti-tumor 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

Testing nivolumab concentration:

The assay is performed using Enzyme Linked Immunosorbent Assay (ELISA). The limit of quantification (LOQ) for nivolumab in serum is 0.12 ¬Ķg/mL.

Testing nivolumab anti-drug antibodies (ADA):

The assay is performed using radioimmunoassay (RIA). The limit of quantification (LOQ) for ADA is 10 AU/mL.

Clinical Relevance

No response or loss of response of treatment with nivolumab.

During treatment, some patients may develop antibodies to nivolumab; anti-drug antibodies (ADA). With level testing of biologics, efficacy of therapy can be improved, as treatment decisions may need to be adapted depending on the test results in conjunction with clinical responses to treatment.

Data and interpretation of nivolumab ADA and its serum levels are still very limited.

Personalized Medicine

Monitoring biologic levels in individual patients allows optimization of treatment efficacy by adjusting therapy depending on the specific response of the patient. When drug levels are decreased in a non-responder, this may reflect formation of inactivating antibodies directed to the biologic treatment. Immunogenicity testing identifies presence or absence of inactivating antibodies, which guides the next treatment decision ‚Äď switch to other biological treatment, lowering of dose or intensify dosing. Reducing drug dosage in well-responding patients with relatively high drug levels cuts down cost. A personalized approach can improve therapy efficacy and quality of life.

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Order of test: Print and complete the request form and send it together with the sample.

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