As with all therapeutic proteins, there is a potential for immunogenicity. In order to benefit from your most valuable biological drug we recommend to measure trough levels along with anti-drug antibodies together from samples taken just before the administration of following dose by SHIKARI® ELISA kits.
Nivolumab is a humanized IgG4 monoclonal anti-PD-1 antibody. Its molecular weight is 146 kDa. Mechanism of Action: Programmed death 1 (PD-1) receptor is a type I membrane protein of 268 amino acids. PD-1 is expressed on the surface of activated T cells, B cells, and macrophages. The binding of PD-1 and its ligands (PD-L1 and PD-L2) on a tumor cell contributes to inhibition of active T-cell immune surveillance of tumors. By inhibiting the PD-1 receptor from binding to its ligands, nivolumab reactivates tumor-specific cytotoxic T lymphocytes in the tumor microenvironment and reactivates anti-tumor immunity. Clinical Dose Selection: The selection of nivolumab dose and schedule of 3 mg/kg Q2W was based on the observed clinical safety and efficacy from 306 patients in trial MDX1106-03 across different dose levels and tumor types.
As with all therapeutic proteins, there is a potential for immunogenicity. Of 532 patients who were treated with OPDIVO 3 mg/kg every 2 weeks and evaluable for the presence of anti-nivolumab antibodies, 67 patients (12.6%) tested positive for treatmentemergent anti-nivolumab antibodies by an electrochemiluminescent (ECL) assay. Neutralizing antibodies against nivolumab were detected in five patients (0.9%). There was no evidence of altered pharmacokinetic profile or toxicity profile with anti-nivolumab binding antibody development. Of 105 patients who were treated with OPDIVO in combination with ipilimumab and evaluable for the presence of anti-nivolumab antibodies, 23 patients (21.9%) tested positive for treatment-emergent anti-nivolumab antibodies by an ECL assay. Neutralizing antibodies against nivolumab were detected in one patient (1%). There was no evidence of altered toxicity profile with anti-nivolumab antibody development. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.
Further reading; Drug information, trough levels and immunogenicity.