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 Programmed cell death 1 ligand 2 (also known as PD-L2, B7-DC) is a protein that in humans is encoded by the ''PDCD1LG2'' gene. PDCD1LG2 has also been designated as CD273 (cluster of differentiation 273). PDCD1LG2 is an immune checkpoint receptor l ...

(hence it is a

checkpoint inhibitor Checkpoint inhibitor therapy is a form of cancer immunotherapy. The therapy targets immune checkpoints, key regulators of the immune system that when stimulated can dampen the immune response to an immunologic stimulus. Some cancers can protect the ...

). It is being investigated as a treatment for advanced solid

tumors A neoplasm () is a type of abnormal and excessive growth of tissue. The process that occurs to form or produce a neoplasm is called neoplasia. The growth of a neoplasm is uncoordinated with that of the normal surrounding tissue, and persists ...

. It is designed to bind less to Fc gamma receptors. It is being developed by

BeiGene BeiGene is a global biotechnology company that specializes in the development of drugs for cancer treatment. Founded in 2010 by Xiaodong Wang and chief executive officer John V. Oyler, the company has offices in Asia, North America, Australia a ...

(after a period with

Celgene Corp Celgene Corporation is a pharmaceutical company that makes cancer and immunology drugs. Its major product is Revlimid (lenalidomide), which is used in the treatment of multiple myeloma, and also in certain anemias. The company is incorporated in ...

Medical uses

China

Tislelizumab was approved by China's

National Medical Products Administration The National Medical Products Administration (NMPA, , formerly the China Food and Drug Administration, or CFDA) was founded on the basis of the former State Food and Drug Administration (SFDA). In March 2013, the former regulatory body was rebra ...

: * on December 27, 2019 to treat patients with classical

Hodgkin’s lymphoma Hodgkin lymphoma (HL) is a type of lymphoma, in which cancer originates from a specific type of white blood cell called lymphocytes, where multinucleated Reed–Sternberg cells (RS cells) are present in the patient's lymph nodes. The condition w ...

(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 Chemotherapy (often abbreviated to chemo and sometimes CTX or CTx) is a type of cancer treatment that uses one or more anti-cancer drugs (chemotherapeutic agents or alkylating agents) as part of a standardized chemotherapy regimen. Chemotherap ...

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 Transitional cell carcinoma, also called urothelial carcinoma, is a type of cancer that typically occurs in the urinary system. It is the most common type of bladder cancer and cancer of the ureter, urethra, and urachus. It accounts for 95% of ...

started in China in 2017. It is in a phase 3 trial for

NSCLC Non-small-cell lung cancer (NSCLC) is any type of epithelial lung cancer other than small-cell lung carcinoma (SCLC). NSCLC accounts for about 85% of all lung cancers. As a class, NSCLCs are relatively insensitive to chemotherapy, compared to sm ...

. A multicenter phase 3 trial for advanced

hepatocellular carcinoma Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer in adults and is currently the most common cause of death in people with cirrhosis. HCC is the third leading cause of cancer-related deaths worldwide. It occurs in t ...

started in Jan 2018.

Pharmacokinetics

Early phase I clinical trial results give an

elimination half-life Biological half-life (also known as elimination half-life, pharmacologic half-life) is the time taken for concentration of a biological substance (such as a medication) to decrease from its maximum concentration ( Cmax) to half of Cmax in the bl ...

of 11 to 17 days.

References

{{monoclonals for immune system Monoclonal antibodies Experimental drugs Orphan drugs