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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.

Sasanlimab

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Sasanlimab

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

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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 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

GU

Non-Muscle Invasive Bladder Cancer

Phase 3 Combination*
Other

Advanced Malignancies/Solid Tumors

Phase 1 Combination*

Phase 1 Combination
Lung

Non-Small Cell Lung Cancer (NSCLC)

Phase 1b/2 Combination*
This information is current as of August 5th 2025.

* Closed to Enrollment

REFERENCES:  Khan H et al. Evolving concepts: immunity in oncology from targets to treatments. J Oncol. 2015;2015:847383. National Cancer Institute. NCI Drug Dictionary: anti-PD-1 checkpoint inhibitor PF-06801591. Accessed February 22, 2020. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pd-1-checkpoint-inhibitor-pf-06801591. Johnson ML et al. Assessment of subcutaneous vs intravenous administration of anti-PD-1 antibody PF-06801591 in patients with advanced solid tumors: a phase 1 dose-escalation trial. JAMA Oncol. 2019;5:999-1007; Zhang N et al. Programmed cell death-1/programmed cell death ligand-1 checkpoint inhibitors: differences in mechanism of action. Immunotherapy. 2019;11(5):429-441. Image is republished  and adapted with permission from Elsevier Science from Ohaegluman KC et al. Human cancer immunotherapy with antibodies to the PD-1 and PD-L1 pathway. Trends Mol Med. 2015;21:24-33. Permission conveyed through Copyright Clearance Center, Inc.; ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT04165317; https://clinicaltrials.gov/study/NCT04181788; https://clinicaltrials.gov/study/NCT06580938; https://clinicaltrials.gov/study/NCT06546553; https://clinicaltrials.gov/study/NCT06870487; https://clinicaltrials.gov/study/NCT06974734. Accessed July 7, 2025 .