Fab fragment of tislelizumab (green) binding the extracellular domain of PD-1 (pale pink). From PDB entry 7BXA
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| Monoclonal antibody | |
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| Type | Whole antibody |
| Source | Humanized |
| Target | PD-1 |
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Tislelizumab (BGB-A317) is a humanized monoclonal antibody directed against PD-1. 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.
It is designed to bind less to Fc gamma receptors.
It is being developed by BeiGene (after a period with Celgene Corp).
Medical uses
China
Tislelizumab was approved by China's 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
- 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.
Clinical trials
Phase I trials began in the US and Australia in June 2015 and were expected to complete in mid-2017. Some early results were announced in July 2016.
A pivotal phase 2 clinical trial for urothelial cancer started in China in 2017.
It is in a phase 3 trial for NSCLC.
A multicenter phase 3 trial for advanced hepatocellular carcinoma started in Jan 2018.
Pharmacokinetics
Early phase I clinical trial results give an elimination half-life of 11 to 17 days.