Cemiplimab
Programmed death receptor-1 (PD-1) is a protein expressed on the surface of T cells and acts as a negative regulator of T-cell activation and proliferation. In other words, PD-1 activation “turns the immune system off,” essentially acting as a brake. This type of inhibitory capability is necessary to prevent lethal inflammation, severe immune reactions, and autoimmunity. However, cancer cells exploit this system. Due to PD-1’s role as a preventer of an uncontrolled or extremely dangerous immune response, PD-1 and similar regulators are called immune checkpoints.
Programmed death ligand-1 (PD-L1) is a protein expressed on the surface of normal cells that helps regulate immune responses by interacting with the PD-1 receptor on T cells. This helps prevent autoimmune reactions. To exploit the PD-1/PD-L1 system and avoid immune detection, some tumor cells will express PDL1 on their cell surface just like normal cells, allowing them to interact with PD-1 on T cells and “turn off” the immune system. With PD-L1, cancer cells prevent identification and elimination by T cells.
Cemiplimab (Libtayo®) is a PD-1 monoclonal antibody checkpoint inhibitor. Cemiplimab selectively binds to PD-1, blocking the PD-1/PD-L1 interaction and thereby “exposing” cancer cells and “turning on” the immune system.
Cemiplimab has several indications. It is indicated for the treatment of patients with metastatic basal cell carcinoma (mBCC) or locally advanced BCC (laBCC) that have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. Use of cemiplimab for BCC does not require testing of PD-L1 expression.
Cemiplimab is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
Cemiplimab is also indicated for non-small cell lung cancer (NSCLC) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with NSCLC with no EGFR, ALK or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic. It is approved as a single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic.
Provider Resources
