![]() Grade 3 or higher treatment-related adverse events occurred in 201 (53%) and 81 (48%) patients in the serplulimab plus chemotherapy group and the placebo plus chemotherapy group, respectively. At the prespecified interim analysis of overall survival (OS), serplulimab plus chemotherapy also significantly prolonged OS compared with placebo plus chemotherapy (median OS of 15.3 months and 11.8 months, respectively hazard ratio, 0.68 95% confidence interval, 0.53–0.87 P = 0.0020). At the prespecified final analysis of progression-free survival (PFS) assessed by the blinded independent radiological review committee, serplulimab plus chemotherapy significantly improved PFS compared with placebo plus chemotherapy (median PFS of 5.8 months and 5.3 months, respectively hazard ratio, 0.60 95% confidence interval, 0.48–0.75 P < 0.0001). In this multicenter, double-blind phase 3 trial, a total of 551 patients with previously untreated, locally advanced or metastatic ESCC and PD-L1 combined positive score of ≥1 were randomized (2:1) to receive serplulimab (an anti-PD-1 antibody 3 mg/kg) or placebo (on day 1), plus cisplatin (50 mg/m 2) (on day 1) and continuous infusion of 5-fluorouracil (1,200 mg/m 2) (on days 1 and 2), once every 2 weeks. First-line systemic therapeutic options for advanced esophageal squamous cell carcinoma (ESCC) are limited. ![]()
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