(Esophageal Squamous Cell Carcinoma) Is Tislelizumab Effective?

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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