Tislelizumab

Tislelizumab, sold under the brand name Tevimbra among others, is a humanized monoclonal antibody directed against PD-1.[5] It prevents PD-1 from binding to the ligands PD-L1 and PD-L2 (hence it is a checkpoint inhibitor). It is designed to bind less to Fc gamma receptors.[6] It is being developed by BeiGene (after a period with Celgene Corp).[7]

Tislelizumab
Fab fragment of tislelizumab (green) binding the extracellular domain of PD-1 (pale pink). From PDB entry 7BXA
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetPD-1
Clinical data
Trade namesTevimbra
Other names
Routes of
administration		Intravenous
Drug classAntineoplastic agent
ATC code
Legal status
Legal status
  • EU: Rx-only[3][4]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG

Medical uses

China

Tislelizumab was approved by China's National Medical Products Administration :

  • in December 2019, to treat people with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies[8]
  • and in April 2020, to treat people 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.[9]

History

Phase I trials began in the US and Australia in June 2015.[10] Some early results were announced in July 2016.[11][5]

A phase II clinical trial for urothelial cancer started in China in 2017.[6]

It is in a phase III trial for NSCLC.[12]

A multicenter phase III trial for advanced hepatocellular carcinoma started in January 2018.[7]

Pharmacokinetics

Phase I clinical trial results give an elimination half-life of 11 to 17 days.[5]

References
  1. Lopes JM (27 July 2018). "BeiGene's Therapy Candidate Appears to Eliminate Tumors in Half of Hodgkin's Patients in Phase 2 Trial". Lymphoma News Today. Philadelphia, Pennsylvania, United States: BioNews Services.
  2. Erickson S (3 July 2018). "3 Reasons BeiGene Needs to Be on Your Radar". The Motley Fool. Retrieved 2 November 2019.
  3. "Tevimbra Product information". Union Register of medicinal products. 19 September 2023. Retrieved 1 October 2023.
  4. "Tevimbra EPAR". European Medicines Agency. 4 October 2023. Retrieved 5 October 2023.
  5. "Meeting Library - Meeting Library". meetinglibrary.asco.org.
  6. "BeiGene (BGNE) Commences Pivotal Trial of PD-1 Antibody BGB-A317 in China in Patients with Urothelial Cancer".
  7. LTD B (2 January 2018). "BeiGene Initiates Global Phase 3 Trial of Anti-PD-1 Antibody Tislelizumab in Patients with Hepatocellular Carcinoma". GlobeNewswire News Room.
  8. "BeiGene scores first China OK with PD-1 — to be manufactured by Boehringer Ingelheim". Endpoints News. 2 January 2020. Retrieved 1 July 2020.
  9. "Ploughing through a crowded PD-(L)1 market, BeiGene loads up on promising lung cancer data". Endpoints News. 14 April 2020. Retrieved 1 July 2020.
  10. Clinical trial number NCT02407990 for "Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Subjects With Advanced Tumors" at ClinicalTrials.gov
  11. "Immunotherapy Trial's Early Results Show Activity in Solid Tumors". 26 July 2016.
  12. Clinical trial number NCT03358875 for "Comparison of Efficacy and Safety of Anti-PD-1 Antibody BGB-A317 Versus Docetaxel as Treatment in the Second- or Third-line Setting in Patients With NSCLC" at ClinicalTrials.gov
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