Sugemalimab is an experimental monoclonal antibody intended for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in combination with chemotherapy.^[1] It is an antineoplastic monoclonal antibody that potentiates T-cell responses, including anti-tumor responses, through blockade of PD-1 binding to PD-L1 ligands.^[1]

It is a fully human monoclonal antibody directed against the immunosuppressive ligand, programmed cell death-1 ligand 1 (PD-L1; cluster of differentiation 274; CD274), with potential immune checkpoint inhibitory and antineoplastic activities.^[2] Upon administration, sugemalimab specifically targets and binds to PD-L1, blocking its binding to and activation of its receptor, programmed cell death 1 (PD-1).^[2] This reverses T-cell inactivation caused by PD-1/PD-L1 signaling and enhances the cytotoxic T-lymphocyte (CTL)-mediated anti-tumor immune response against PD-L1-expressing tumor cells.^[2] PD-L1 is overexpressed by many human cancer cell types.^[2] PD-L1 binding to PD-1 on T-cells suppresses the immune system and results in immune evasion.^[2] PD-1, a transmembrane protein belonging to the immunoglobulin superfamily expressed on activated T-cells, is a negative regulator of the immune system that limits the expansion and survival of CD8-positive T-cells.^[2] Anti-PD-L1 monoclonal antibody CS1001 mirrors natural immunoglobulin G4 (IgG4), potentially reducing immunogenicity and other toxicities.^[2]

Society and culture

Legal status

In May 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Cejemly, intended for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in combination with chemotherapy.^[1][3] The applicant for this medicinal product is SFL Pharmaceuticals Deutschland GmbH.^[1]

Names

Sugemalimab is the international nonproprietary name.^[4]