Tislelizumab was approved for medical use in China in December 2019,[8][9] in the European Union in September 2023,[5] in the United States in March 2024,[10][11] and in Australia in May 2024.[1]
Medical uses
In China, tislelizumab is indicated to treat people with classical Hodgkin lymphoma who have received at least two prior therapies;[9] 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.[12]
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.[5] In November 2024, the European Commission expanded the indication of tislelizumab for use alongside platinum- and fluoropyrimidine-based chemotherapy to treat people with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma; and, in combination with platinum-based chemotherapy, for those with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma.[5][13]
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;[4] and, in combination with platinum and fluoropyrimidine-based chemotherapy, it is indicated for the first-line treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1.[4]
Adverse events are more common when combined with chemotherapy.[16]
Pharmacokinetics
Phase I clinical trial from 2016 has results suggesting an elimination half-life of 11 to 17 days.[17] A 2021 structural and functional analysis suggests a t1/2 of 238 ± 32 minutes, 30- to 80-times higher than pembrolizumab and nivolumab.[18]
History
Phase I trials began in the United States and Australia in June 2015.[19] Some early results were announced in July 2016.[20][17]
Tislelizumab "demonstrated efficacy and tolerability" in a multicenter phase III trial for advanced hepatocellular carcinoma started in January 2018.[7][22]
In November 2024, the European Medicines Agency expanded the indication of tislelizumab as part of a first-line combination treatment for adults with advanced gastric or esophageal cancer.[5]
^ abDesai J, Markman B, Sandhu SK, Gan HK, Friedlander M, Tran B, et al. (20 May 2016). "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): 3066. doi:10.1200/JCO.2016.34.15_suppl.3066.
^Clinical trial number NCT02407990 for "Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Subjects With Advanced Tumors" at ClinicalTrials.gov
^World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.
Clinical trial number NCT03430843 for "A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma" at ClinicalTrials.gov
