Tislelizumab

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Tislelizumab
Tislelizumab PB-1 7BXA.png
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
Other names
ATC code
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG

Tislelizumab[3][4] (BGB-A317) 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 being investigated as a treatment for advanced solid tumors.[5]

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 :

  • on December 27, 2019 to treat patients with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies[8]
  • and on April 10, 2020 to treat 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.[9]

Clinical trials

Phase I trials began in the US and Australia in June 2015 and were expected to complete in mid-2017.[10] Some early results were announced in July 2016.[11][5]

A pivotal phase 2 clinical trial for urothelial cancer started in China in 2017.[6]

It is in a phase 3 trial for NSCLC.[12]

A multicenter phase 3 trial for advanced hepatocellular carcinoma started in Jan 2018.[7]

Pharmacokinetics

Early 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 (July 3, 2018). "3 Reasons BeiGene Needs to Be on Your Radar". The Motley Fool. Retrieved 2 Nov 2019.
  3. ^ "tislelizumab (BGB-A317)". BioCentury – BCIQ.
  4. ^ "Investor Overview". BeiGene LTD.
  5. ^ a b c d "Meeting Library - Meeting Library". meetinglibrary.asco.org.
  6. ^ a b "BeiGene (BGNE) Commences Pivotal Trial of PD-1 Antibody BGB-A317 in China in Patients with Urothelial Cancer".
  7. ^ a b LTD, BeiGene (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. 2020-01-02. Retrieved 2020-07-01.
  9. ^ "Ploughing through a crowded PD-(L)1 market, BeiGene loads up on promising lung cancer data". Endpoints News. 2020-04-14. Retrieved 2020-07-01.
  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