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Tislelizumab

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Pharmaceutical compound
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 namesBGB-A317, tislelizumab-jsgr
AHFS/Drugs.comMonograph
MedlinePlusa624026
License data
Pregnancy
category
  • AU: D
Routes of
administration		Intravenous
Drug classAntineoplastic agent
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG

Tislelizumab, sold under the brand name Tevimbra among others, is an anti-cancer medication used for the treatment of various forms of cancer. It is a humanized monoclonal antibody directed against programmed death receptor-1. It is being developed by BeiGene.

Tislelizumab was approved for medical use in China in December 2019, in the European Union in September 2023, in the United States in March 2024, and in Australia in May 2024.

Medical uses

In China, tislelizumab is indicated to treat people with classical Hodgkin lymphoma who have received at least two prior therapies; and to treat people with locally advanced or metastatic urothelial carcinoma with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within twelve months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In the EU, tislelizumab is indicated for the treatment of adults with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy. In November 2024, the European Commission expanded the indication of tislelizumab for use alongside platinum- and fluoropyrimidine-based chemotherapy to treat people with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma; and, in combination with platinum-based chemotherapy, for those with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma.

In the US, tislelizumab is indicated for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor; and, in combination with platinum and fluoropyrimidine-based chemotherapy, it is indicated for the first-line treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1.

Adverse effects

Adverse effects include anemia, leukopenia, thrombocytopenia, nausea, increased aspartate transaminase (AST), neutropenia, fatigue, decreased appetite, vomiting, musculoskeletal pain, constipation, hypoproteinemia and rash. Fatal events such as respiratory infection or failure, and hepatic injury have been reported.

Adverse events are more common when combined with chemotherapy.

Pharmacokinetics

Phase I clinical trial from 2016 has results suggesting an elimination half-life of 11 to 17 days. A 2021 structural and functional analysis suggests a t1/2 of 238 ± 32 minutes, 30- to 80-times higher than pembrolizumab and nivolumab.

History

Phase I trials began in the United States and Australia in June 2015. Some early results were announced in July 2016.

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

Tislelizumab "demonstrated efficacy and tolerability" in a multicenter phase III trial for advanced hepatocellular carcinoma started in January 2018.

In November 2024, the European Medicines Agency expanded the indication of tislelizumab as part of a first-line combination treatment for adults with advanced gastric or esophageal cancer.

Society and culture

Names

Tislelizumab is the international nonproprietary name.

References

  1. ^ "Tevimbra (tislelizumab)". Therapeutic Goods Administration (TGA). 28 June 2024. Retrieved 7 July 2024.
  2. "Tevimbra (Beigene Aus Pty Ltd)". Therapeutic Goods Administration (TGA). 1 July 2024. Retrieved 7 July 2024.
  3. "Tevimbra tislelizumab 100 mg/10 mL concentrated injection vial (391176)". Therapeutic Goods Administration (TGA). 31 May 2024. Retrieved 27 December 2024.
  4. ^ "Tevimbra- tislelizumab injection, solution, concentrate". DailyMed. 16 March 2024. Archived from the original on 2 April 2024. Retrieved 2 April 2024.
  5. ^ "Tevimbra EPAR". European Medicines Agency (EMA). 4 October 2023. Archived from the original on 28 November 2023. Retrieved 5 October 2023.
  6. "Tevimbra Product information". Union Register of medicinal products. 19 September 2023. Retrieved 1 October 2023.
  7. ^ "BeiGene Initiates Global Phase 3 Trial of Anti-PD-1 Antibody Tislelizumab in Patients with Hepatocellular Carcinoma". BeiGene (Press release). 2 January 2018. Archived from the original on 20 April 2019. Retrieved 20 April 2019 – via GlobeNewswire.
  8. Lee A, Keam SJ (April 2020). "Tislelizumab: First Approval". Drugs. 80 (6): 617–624. doi:10.1007/s40265-020-01286-z. PMID 32185681.
  9. ^ "BeiGene scores first China OK with PD-1 — to be manufactured by Boehringer Ingelheim". Endpoints News. 2 January 2020. Archived from the original on 2 July 2020. Retrieved 1 July 2020.
  10. "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 29 April 2024. Archived from the original on 30 April 2024. Retrieved 30 April 2024.
  11. "Ploughing through a crowded PD-(L)1 market, BeiGene loads up on promising lung cancer data". Endpoints News. 14 April 2020. Archived from the original on 1 July 2020. Retrieved 1 July 2020.
  12. "Tislelizumab/Chemo Approved by European Commission For ESCC/GEJ". Cancer Network. 27 November 2024. Retrieved 28 November 2024.
  13. Zhou Q, Qin Z, Yan P, Wang Q, Qu J, Chen Y (2023). "Immune-related adverse events with severe pain and ureteral expansion as the main manifestations: a case report of tislelizumab-induced ureteritis/cystitis and review of the literature". Frontiers in Immunology. 14: 1226993. doi:10.3389/fimmu.2023.1226993. PMC 10587548. PMID 37869004.
  14. Zhang L, Geng Z, Hao B, Geng Q (January 2022). "Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody". Cancer Control. 29: 10732748221111296. doi:10.1177/10732748221111296. PMC 9358212. PMID 35926155.
  15. Guo Y, Jia J, Hao Z, Yang J (2023). "Tislelizumab plus chemotherapy versus pembrolizumab plus chemotherapy for the first-line treatment of advanced non-small cell lung cancer: systematic review and indirect comparison of randomized trials". Frontiers in Pharmacology. 14: 1172969. doi:10.3389/fphar.2023.1172969. PMC 10318343. PMID 37408759.
  16. ^ Desai J, Markman B, Sandhu SK, Gan HK, Friedlander M, Tran B, et al. (20 May 2016). "A phase I dose-escalation study of BGB-A317, an anti-programmed death-1 (PD-1) mAb in patients with advanced solid tumors". Journal of Clinical Oncology. 34 (15_suppl): 3066. doi:10.1200/JCO.2016.34.15_suppl.3066.
  17. Hong Y, Feng Y, Sun H, Zhang B, Wu H, Zhu Q, et al. (March 2021). "Tislelizumab uniquely binds to the CC' loop of PD-1 with slow-dissociated rate and complete PD-L1 blockage". FEBS Open Bio. 11 (3): 782–792. doi:10.1002/2211-5463.13102. PMC 7931243. PMID 33527708.
  18. Clinical trial number NCT02407990 for "Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Subjects With Advanced Tumors" at ClinicalTrials.gov
  19. Martins I (26 July 2016). "Immunotherapy Trial's Early Results Show Activity in Solid Tumors". Immuno-Oncology News. BioNews Inc. Archived from the original on 2 February 2017. Retrieved 24 January 2017.
  20. "BeiGene (BGNE) Commences Pivotal Trial of PD-1 Antibody BGB-A317 in China in Patients with Urothelial Cancer". Archived from the original on 3 July 2020. Retrieved 20 April 2019.
  21. "Novartis announces tislelizumab demonstrated efficacy and tolerability in first-line advanced liver cancer in Phase III trial". Novartis (Press release). Archived from the original on 27 February 2024. Retrieved 2 April 2024.
  22. World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.

Further reading

External links

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