The US FDA has approved tislelizumab as a standalone treatment for adult patients with unresectable or metastatic esophageal squamous cell carcinoma following prior chemotherapy that didn't involve a PD-(L)1 inhibitor. Tislelizumab is a specially engineered humanized immunoglobulin G4 (IgG4) monoclonal antibody targeting programmed cell death protein 1 (PD-1) with precise affinity and specificity. Its design aims to reduce interaction with Fc-gamma (Fcγ) receptors on macrophages, thereby assisting immune cells in recognizing and fighting tumors.
Clinical trial The approval of tislelizumab is based on findings from the RATIONALE 302 trial, where the drug demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy in the intention-to-treat population. In this group, the median overall survival with tislelizumab was 8.6…
