The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.


Geo Regions


Sasanlimab is an investigational compound. Its safety and efficacy have not been established.

Overview + Rationale

  • Programmed death-1 (PD-1) is a protein that belongs to the CD-28 family and is expressed on T cells, dendritic cells, natural killer cells, macrophages, and B cells 
  • PD-1 functions as an immune checkpoint that negatively regulates T-cell activation and effector function when activated by its ligands, and may play an important role in tumor evasion from host immunity 
  • Sasanlimab is a humanized immunoglobulin G4 monoclonal antibody that binds PD-1 to block its interaction with PD-L1 and PD-L2 
  • Sasanlimab is administered either by subcutaneous injection (SC)

Mechanism of Action

  • PD-1 is an immune checkpoint receptor, which mainly expresses on activated T, B, dendritic (DCs), natural killer (NK), and Treg cells 
  • On the surface of activated T cells, PD-1 expression is upregulated after the recognition of peripheral antigens by T cells; subsequently, the elevated binding of PD-1 to PD-L1 becomes a key step for downstream inhibitory signaling 
  • PD-1 is also associated with increased Treg-cell proliferation and enhanced immunosuppressive function

Stage of Development

small icon representing GU Cancer
Non-Muscle Invasive Bladder Cancer
Phase 3*
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Non-Small Cell Lung Cancer (NSCLC)
Phase 1b/2 Monotherapy*

Phase 1b/2 Combination*