Tislelizumab (Baizean)

Mechanism of action

From the NCI Drug Dictionary: A monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, tislelizumab binds to PD-1 and inhibits the binding of PD-1 to the PD-1 ligands programmed cell death-1 ligand 1 (PD-L1), and PD-1 ligand 2 (PD-L2). This prevents the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells.

Diseases for which it is used

• Esophageal squamous cell carcinoma
• Hepatocellular carcinoma
• Classical Hodgkin lymphoma
• Nasopharyngeal carcinoma
• Non-small cell lung cancer
  • Non-small cell lung cancer, nonsquamous
  • Non-small cell lung cancer, squamous
• Urothelial carcinoma
• MSI-H or dMMR solid tumors (tissue-agnostic)

History of changes in NMPA indication

• 2019-12-26: Initial approval
• Uncertain date: Full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy.
• Uncertain date: Full approval for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy.
• Uncertain date: Full approval for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy.
• Uncertain date: Conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies
• Uncertain date: Conditional approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
• Uncertain date: Conditional approval for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy
• Uncertain date: Conditional approval for the treatment of patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors.

History of changes in EMA indication

• 2023-09-19: Initial marketing authorization as Tevimbra. Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.

Also known as

• Code name: BGB-A317
• Generic name: tilelizumab
• Brand names: Baizean, Tevimbra