Multinational phase 3 study of second-line tislelizumab versus IC chemotherapy for advanced/metastatic ESCC

The phase 3 study RATIONALE 302 (512 patients from 132 centers in 10 countries) included patients with advanced or metastatic esophageal squamous cell carcinoma after progression on first-line systemic therapy. The patients were randomized to tislelizumab (anti-PD-1) or investigator’s choice of chemotherapy. The median overall survival was 8.6 months with tislelizumab versus 6.3 months with chemotherapy (HR 0.70; p=0.0001) in the ITT population and 10.3 months with tislelizumab versus 6.8 months with chemotherapy in de PD-L1 + population (HR 0.54; p=0.0006). Overall respons rate, duration of response, and adverse events rate were better with tislelizumab compared to chemotherapy.