The FDA approved nivolumab on May 20, 2021, for the adjuvant treatment of completely resected (negative margins) esophageal or gastroesophageal junction cancer (EC/GEJC) in patients who had residual pathologic disease following chemoradiotherapy. The approval was based on data from the double-blind CheckMate 577 trial, which randomly allocated patients to receive nivolumab or placebo. Disease-free survival (DFS) was the primary endpoint. At the time of the final DFS analysis and the prespecified interim overall survival (OS) analysis, the estimated median DFS was 22.4 months [95% confidence interval (CI), 16.6–34.0] in the nivolumab arm versus 11.0 months (95% CI, 8.3–14.3) in the placebo arm, with an HR of 0.69 (95% CI, 0.56–0.85; two-sided P value = 0.0003). An unblinded review of OS did not indicate a detrimental effect on survival. Adverse reactions occurring in ≥20% of patients receiving nivolumab were fatigue/asthenia, diarrhea, nausea, rash, musculoskeletal pain, and cough. Approval of nivolumab is likely to change the treatment paradigm for the adjuvant treatment of patients with completely resected (negative margins) EC/GEJC who have residual pathologic disease following chemoradiotherapy based on the study results and favorable risk:benefit of nivolumab administration.

中文翻译：

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FDA 批准摘要：纳武单抗用于成人完全切除食管/胃食管交界处癌和残留病理性疾病的辅助治疗

FDA 于 2021 年 5 月 20 日批准纳武单抗用于辅助治疗完全切除（阴性切缘）食管癌或胃食管交界癌（EC/GEJC）的放化疗后有残留病理性疾病的患者。该批准基于双盲 CheckMate 577 试验的数据，该试验随机分配患者接受纳武单抗或安慰剂治疗。无病生存期（DFS）是主要终点。在进行最终 DFS 分析和预先指定的中期总生存 (OS) 分析时，纳武单抗组的估计中位 DFS 为 22.4 个月 [95% 置信区间 (CI)，16.6–34.0]，而纳武单抗组为 11.0 个月（95% CI） ，8.3–14.3）在安慰剂组中，HR 为 0.69（95% CI，0.56–0.85；两侧 P 值 = 0.0003）。对 OS 的非盲审查并未表明对生存有不利影响。≥20%接受纳武利尤单抗治疗的患者发生的不良反应为疲劳/虚弱、腹泻、恶心、皮疹、肌肉骨骼疼痛和咳嗽。基于研究结果和纳武利尤单抗给药的有利风险：获益，纳武利尤单抗的批准可能会改变完全切除（阴性切缘）EC/GEJC且放化疗后有残留病理性疾病的患者辅助治疗的治疗模式。