Tislelizumab Explained

Type:mab
Mab Type:mab
Source:zu
Target:PD-1
Tradename:Tevimbra
Dailymedid:Tislelizumab
Pregnancy Au:D
Pregnancy Au Comment:[1]
Routes Of Administration:Intravenous
Class:Antineoplastic agent
Atc Prefix:L01
Atc Suffix:FF09
Legal Au:S4
Legal Au Comment:[2]
Legal Us:Rx-only
Legal Us Comment:[3]
Legal Eu:Rx-only
Legal Eu Comment:[4] [5]
Legal Status:Rx-only
Cas Number:1858168-59-8
Drugbank:DB14922
Chemspiderid:none
Unii:0KVO411B3N
Kegg:D11487
Synonyms:BGB-A317, tislelizumab-jsgr

Tislelizumab, sold under the brand name Tevimbra among others, 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,[6] in the European Union in September 2023, and in the United States in March 2024.[7]

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.[8]

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 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.

Adverse effects

Adverse effects include anemia, leukopenia, thrombocytopenia, nausea, increased aspartate transaminase (AST), neutropenia, fatigue, decreased appetite, vomiting, musculoskeletal pain, constipation, hypoproteinemia and rash.[9] Fatal events such as respiratory infection or failure, and hepatic injury have been reported.[10]

Adverse events are more common when combined with chemotherapy.[11]

Pharmacokinetics

Phase I clinical trial from 2016 has results suggesting an elimination half-life of 11 to 17 days.[12] A 2021 structural and functional analysis suggests a t of 238 ± 32 minutes, 30- to 80-times higher than pembrolizumab and nivolumab.[13]

History

Phase I trials began in the US and Australia in June 2015. Some early results were announced in July 2016.[14] [12]

A phase II clinical trial for urothelial cancer started in China in 2017.[15]

Tislelizumab "demonstrated efficacy and tolerability" in a multicenter phase III trial for advanced hepatocellular carcinoma started in January 2018.[16] [17]

Society and culture

Names

Tislelizumab is the international nonproprietary name.[18]

External links

Notes and References

  1. Web site: Tevimbra (tislelizumab) . Therapeutic Goods Administration (TGA) . 28 June 2024 . 7 July 2024.
  2. Web site: Tevimbra (Beigene Aus Pty Ltd) . Therapeutic Goods Administration (TGA) . 1 July 2024 . 7 July 2024.
  3. Web site: Tevimbra- tislelizumab injection, solution, concentrate . DailyMed . 16 March 2024 . 2 April 2024 . 2 April 2024 . https://web.archive.org/web/20240402061527/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08ef1e3e-496f-4b0b-94ee-fbba3cc1985a . live .
  4. Web site: Tevimbra EPAR . European Medicines Agency . 4 October 2023 . 5 October 2023 . 28 November 2023 . https://web.archive.org/web/20231128111358/https://www.ema.europa.eu/en/medicines/human/EPAR/tevimbra . live .
  5. Web site: Tevimbra Product information . Union Register of medicinal products . 19 September 2023 . 1 October 2023.
  6. Web site: 2 January 2020. BeiGene scores first China OK with PD-1 — to be manufactured by Boehringer Ingelheim. 1 July 2020. Endpoints News. 2 July 2020. https://web.archive.org/web/20200702034139/https://endpts.com/beigene-scores-first-china-ok-with-pd-1-to-be-manufactured-by-boehringer-ingelheim/. live.
  7. Web site: Novel Drug Approvals for 2024 . U.S. Food and Drug Administration (FDA) . 29 April 2024 . 30 April 2024 . 30 April 2024 . https://web.archive.org/web/20240430031024/https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024 . live .
  8. Web site: 14 April 2020. Ploughing through a crowded PD-(L)1 market, BeiGene loads up on promising lung cancer data. 1 July 2020. Endpoints News. 1 July 2020. https://web.archive.org/web/20200701232358/https://endpts.com/ploughing-through-a-crowded-pd-l1-market-beigene-loads-up-on-promising-lung-cancer-data/. live.
  9. Zhou Q, Qin Z, Yan P, Wang Q, Qu J, Chen Y . 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 . 2023 . 37869004 . 10587548 . 10.3389/fimmu.2023.1226993 . free .
  10. Zhang L, Geng Z, Hao B, Geng Q . Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody . Cancer Control . 29 . 10732748221111296 . January 2022 . 35926155 . 9358212 . 10.1177/10732748221111296 .
  11. Guo Y, Jia J, Hao Z, Yang J . 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 . 2023 . 37408759 . 10318343 . 10.3389/fphar.2023.1172969 . free .
  12. Desai J, Markman B, Sandhu SK, Gan HK, Friedlander M, Tran B, Meniawy T, Boolell V, Colyer D, Norris C, Ameratunga M, Yang J, Li K, Wang L, Luo L, Qin Z, Millward M . 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 . 20 May 2016 . 10.1200/JCO.2016.34.15_suppl.3066 . 3066.
  13. Hong Y, Feng Y, Sun H, Zhang B, Wu H, Zhu Q, Li Y, Zhang T, Zhang Y, Cui X, Li Z, Song X, Li K, Liu M, Liu Y . 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 . March 2021 . 33527708 . 7931243 . 10.1002/2211-5463.13102 .
  14. Web site: Martins I . Immuno-Oncology News . BioNews Inc. . Immunotherapy Trial's Early Results Show Activity in Solid Tumors . 26 July 2016 . 24 January 2017 . 2 February 2017 . https://web.archive.org/web/20170202014148/https://immuno-oncologynews.com/2016/07/26/beigene-presents-initial-clinical-data-showing-anti-cancer-activity-in-range-of-solid-tumors/ . live .
  15. Web site: BeiGene (BGNE) Commences Pivotal Trial of PD-1 Antibody BGB-A317 in China in Patients with Urothelial Cancer. 20 April 2019. 3 July 2020. https://web.archive.org/web/20200703001233/https://www.streetinsider.com/Corporate+News/BeiGene+(BGNE)+Commences+Pivotal+Trial+of+PD-1+Antibody+BGB-A317+in+China+in+Patients+with+Urothelial+Cancer/13068864.html. live.
  16. BeiGene Initiates Global Phase 3 Trial of Anti-PD-1 Antibody Tislelizumab in Patients with Hepatocellular Carcinoma. BeiGene. 2 January 2018. GlobeNewswire. 20 April 2019. 20 April 2019. https://web.archive.org/web/20190420020222/http://www.globenewswire.com/news-release/2018/01/02/1276905/0/en/BeiGene-Initiates-Global-Phase-3-Trial-of-Anti-PD-1-Antibody-Tislelizumab-in-Patients-with-Hepatocellular-Carcinoma.html. live.
  17. Novartis announces tislelizumab demonstrated efficacy and tolerability in first-line advanced liver cancer in Phase III trial . Novartis . 2 April 2024 . 27 February 2024 . https://web.archive.org/web/20240227040234/https://www.novartis.com/news/media-releases/novartis-announces-tislelizumab-demonstrated-efficacy-and-tolerability-first-line-advanced-liver-cancer-phase-iii-trial . live .
  18. ((World Health Organization)) . 2018 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79 . WHO Drug Information . 32 . 1 . 10665/330941 . free . World Health Organization .

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