(Esophageal Squamous Cell Carcinoma) Is Tislelizumab Effective?
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On April 20, 2022, Lin Shen et al. from Peking University Cancer Hospital published in the medical journal Journal of Clinical Oncology the efficacy and safety results of anti-PD-1 antibody Tislelizumab as second-line treatment for patients with progressive, metastatic esophageal squamous cell carcinoma in the RATIONALE-302 Phase III clinical trial.
The RATIONALE-302 open-label Phase III trial randomized patients with progressive or metastatic esophageal squamous cell carcinoma who had received first-line treatment (N=512) in a 1:1 ratio into the Tislelizumab group (200 mg every three weeks, N=256) and the chemotherapy group (N=256). The primary endpoint was overall survival (OS) in all patients; the secondary endpoint was OS in PD-L1-positive patients.
The final analysis results were as follows. The primary endpoint (all patients) median OS: Tislelizumab group 8.6 months vs. chemotherapy group 6.3 months — a significant improvement. The secondary endpoint (PD-L1-positive patients) median OS: Tislelizumab group 10.3 months vs. chemotherapy group 6.8 months — an improvement.
Other endpoints: ORR — Tislelizumab group 20.3% vs. chemotherapy group 9.8%; median duration of response — Tislelizumab group 7.1 months vs. chemotherapy group 4.0 months; Grade 3 or higher adverse event rate — Tislelizumab group 18.8% vs. chemotherapy group 55.8%.
Based on RATIONALE-302 results, Lin Shen et al. concluded: Anti-PD-1 antibody Tislelizumab as second-line treatment for patients with progressive, metastatic esophageal squamous cell carcinoma improved overall survival compared to chemotherapy. PD-L1-positive patients also reflected significant survival benefits, with no safety concerns.
Source: https://ascopubs.org/doi/full/10.1200/JCO.21.01926
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