Tislelizumab

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, in the European Union in September 2023, and in the United States in March 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 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. 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 t$1/2$ of 238 ± 32 minutes, 30- to 80-times higher than pembrolizumab and nivolumab.

History
Phase I trials began in the US 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.

Names
Tislelizumab is the international nonproprietary name.