A5101720925- Cancer Immunotherapy and Biomarkers
- Lymphoma Diagnosis and Treatment
- Immune Cell Function and Interaction
- Chronic Lymphocytic Leukemia Research
- Immunotherapy and Immune Responses
- Monoclonal and Polyclonal Antibodies Research
- CAR-T cell therapy research
- Biosimilars and Bioanalytical Methods
BeiGene (China)
2025
Tislelizumab, an anti-programmed cell death protein 1 monoclonal antibody, has demonstrated improved survival benefits over standard of care for multiple cancer indications. We present the clinical rationale and data supporting tislelizumab dose recommendation in patients with advanced tumors. The phase I, first-in-human, dose-finding BGB-A317-001 study (data cutoff [DCO]: August 2017) examined following dosing regimens: 0.5-10 mg/kg every 2 weeks (q2w), 2-5 q2w or q3w, 200 mg q3w. Similar...
ABSTRACT Tislelizumab 200 mg once every 3 weeks (Q3W) is approved for the treatment of multiple cancers. We used a model‐based approach to propose three alternative dosing regimens, 150 Q2W, 300 Q4W, and 400 Q6W, with aims providing flexible regimens compatible background chemotherapy and/or reducing infusion visits. A previously developed population pharmacokinetic model was simulate exposure regimens. Regulatory guidance on define pharmacokinetics‐based criteria. Alternative doses were...
394 Background: Tislelizumab (TIS; BGB-A317) is approved for the treatment of multiple solid tumors, administered at 200 mg every 3 weeks (Q3W), and has demonstrated a flat exposure–response relationship across wide range doses. We evaluated alternative dosing regimens TIS 150 2 (Q2W), 300 4 (Q4W), 400 6 (Q6W) using model-based approach with aim alleviating patient burden by providing longer intervals and/or flexibility compatible background chemotherapy to meet needs patients healthcare...