Tislelizumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | PD-1 |
| Clinical data | |
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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 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
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
- ^ 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.
- ^ Erickson, Simon (July 3, 2018). "3 Reasons BeiGene Needs to Be on Your Radar". The Motley Fool. Retrieved 2 Nov 2019.
- ^ "tislelizumab (BGB-A317)". BioCentury – BCIQ.
- ^ "Investor Overview". BeiGene LTD.
- ^ a b c d "Meeting Library - Meeting Library". meetinglibrary.asco.org.
- ^ a b "BeiGene (BGNE) Commences Pivotal Trial of PD-1 Antibody BGB-A317 in China in Patients with Urothelial Cancer".
- ^ 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.
- ^ "BeiGene scores first China OK with PD-1 — to be manufactured by Boehringer Ingelheim". Endpoints News. 2020-01-02. Retrieved 2020-07-01.
- ^ "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.
- ^ "Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Subjects With Advanced Tumors - Full Text View - ClinicalTrials.gov". clinicaltrials.gov.
- ^ "Immunotherapy Trial's Early Results Show Activity in Solid Tumors". 26 July 2016.
- ^ "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 - Full Text View - ClinicalTrials.gov". clinicaltrials.gov.