BeiGene has dosed the first patient in a Phase lll clinical trial of tislelizumab in combination with chemotherapy as a first-line treatment for patients with Stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC) in China.
The pivotal, open-label, multi-centre trial intends to enrol around 320 chemotherapy naïve patients who have Stage IIIB or IV non-squamous NSCLC in China.
It is expected to compare progression-free survival (PFS) as evaluated by the Independent Review Committee (IRC) per response evaluation criteria in solid tumours v1.1 (RECIST v1.1).
The trial’s key secondary endpoints are overall survival, overall response rate, progressive-free survival (PFS) by investigator, and safety and tolerability.
Shanghai Jiao Tong University Shanghai Chest Hospital Shanghai Lung Cancer Center director Shun Lu is the principal investigator of the trial.
BeiGene China Development senior vice-president and head Lai Wang said: “As shown by the most recent data from other checkpoint inhibitors, combining immunotherapy and chemotherapy can improve anti-tumour activity and significantly improve outcomes for patients.
“Our Phase lll study will assess whether the addition of tislelizumab to standard-of-care chemotherapy will improve outcomes in Chinese patients with advanced lung cancer, a disease known for its poor prognoses even with chemotherapy treatment.”
Tislelizumab is currently being investigated as a humanised monoclonal antibody that belongs to a class of immuno-oncology agents called immune checkpoint inhibitors.
The solution is developed to bind to PD-1, a cell surface receptor that helps in downregulating the immune system by preventing the activation of T-cells.
Tislelizumab is currently being investigated in various global Phase lll trials in solid tumours, including second-line non-small cell lung cancer, first-line hepatocellular carcinoma, and second-line esophageal squamous cell carcinoma.
In addition, two global Phase ll trials in previously treated advanced hepatocellular carcinoma and relapsed/refractory mature T-cell and natural killer-cell lymphomas, as well as two pivotal Phase ll trials in China in relapsed/refractory classical Hodgkin’s lymphoma and second-line urothelial cancer have also been carried out to investigate tislelizumab.