Nivolumab (Anti-PD-1 Immunotherapy)

Nivolumab (brand name Opdivo) is a fully human IgG4 kappa monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Cancer cells express PD-L1 and PD-L2 ligands that engage the PD-1 receptor on T cells and suppress T-cell activation; this is one of the principal pathways of tumor immune escape. Nivolumab binds PD-1 with high affinity, releases this inhibition, and restores effector T-cell activity against the tumor.

Clinical indications are broad: advanced melanoma (alone or with ipilimumab), non-small cell lung cancer (first line in PD-L1 ≥1% or in chemotherapy combinations), renal cell carcinoma (first line with ipilimumab), classical Hodgkin lymphoma (after autologous transplant relapse), head and neck squamous cell carcinoma, urothelial carcinoma, hepatocellular carcinoma, microsatellite-instability-high (MSI-H/dMMR) colorectal cancer, esophageal squamous cell carcinoma, and gastric adenocarcinoma. It is also used in the adjuvant setting for resectable melanoma, NSCLC, and esophageal cancer.

Standard dosing regimens are 240 mg IV every 2 weeks or 480 mg IV every 4 weeks. In combinations with ipilimumab, four induction doses are followed by monotherapy. The hallmark of immunotherapy is the potential for durable, long-lasting responses, although the response rate varies by tumor type from 15% to 60%. Predictive biomarkers include PD-L1 expression (TPS, CPS), tumor mutational burden (TMB), and MSI-H status.