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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

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

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

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

References

  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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