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

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]

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. 1 2 3 "Meeting Library - Meeting Library". meetinglibrary.asco.org.
  6. 1 2 "BeiGene (BGNE) Commences Pivotal Trial of PD-1 Antibody BGB-A317 in China in Patients with Urothelial Cancer".
  7. 1 2 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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