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Mattsnod/sandbox
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetPD-1
Clinical data
Other names
ATC code
  • none
Identifiers
CAS Number
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.[7]

Medical Uses

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Tislelizumab was approved by the China 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

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Clinical trials of tislelizumab include:

  • Phase 1 trial in patients with advanced solid tumors (NCT02407990)[10]
  • Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with non-small cell lung cancer (NSCLC) (NCT03358875)[11]
  • Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC) (NCT03412773)[12]
  • Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897)[13]
  • Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC) (NCT03430843)[14]
  • Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747)[15]
  • Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205)[16]
  • Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889)[17]
  • Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657)[18]
  • Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442)[19]
  • Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986)[20]
  • Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590)[21]
  • Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977)[22]
  • Phase 2 trial in patients with locally advanced or metastatic urothelial bladder cancer (NCT04004221)[23]
  • Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716)[24]

Pharmacokinetics

[edit]

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

References

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  1. ^ Lopes, Jose Marques (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, Simon (July 3, 2018). "3 Reasons BeiGene Needs to Be on Your Radar". The Motley Fool. Retrieved 2 Nov 2019.{{cite web}}: CS1 maint: url-status (link)
  3. ^ "tislelizumab (BGB-A317)". BioCentury – BCIQ.
  4. ^ "Investor Overview". BeiGene LTD.
  5. ^ a b c "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. ^ "Celgene hands PD-1 tislelizumab med back to BeiGene, forfeiting $150M". Fierce Biotech. 2019-06-17. Retrieved 2020-07-01.{{cite web}}: CS1 maint: url-status (link)
  8. ^ "BeiGene scores first China OK with PD-1 — to be manufactured by Boehringer Ingelheim". Endpoints News. 2020-01-02. Retrieved 2020-07-01.{{cite web}}: CS1 maint: url-status (link)
  9. ^ "Ploughing through a crowded PD-(L)1 market, BeiGene loads up on promising lung cancer data". Endpoints News. 20200414. Retrieved 2020-07-01. {{cite web}}: Check date values in: |date= (help)CS1 maint: url-status (link)
  10. ^ "Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-03.
  11. ^ "Comparison of Efficacy and Safety of Anti-PD-1 Antibody BGB-A317 Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With NSCLC - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-01.
  12. ^ "Phase 3 Study of Tislelizumab Versus Sorafenib in Participants With Unresectable HCC - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-01.
  13. ^ "Study of BGB-A317 in Participants With Previously Treated Unresectable HCC - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-01.
  14. ^ "A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-01.
  15. ^ "A Study Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer. - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-01.
  16. ^ "A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous NSCLC - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-01.
  17. ^ "Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-01.
  18. ^ "Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-01.
  19. ^ "A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-01.
  20. ^ "Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-01.
  21. ^ "Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Patient With ESCC - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-01.
  22. ^ "Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-01.
  23. ^ "Study of BGB-A317 in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-06.
  24. ^ "Study of Platinum Plus Etoposide With or Without BGB-A317 in Participants With Untreated Extensive-Stage Small Cell Lung Cancer - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2020-07-01.

Category:Monoclonal antibodies Category:Experimental drugs

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