A multicentre, randomized, double-blind, phase III trial reported positive results for sugemalimab (a PDL1 antibody) plus chemotherapy for the treatment of advanced oesophageal squamous cell carcinoma (ESCC).

A total of 540 adults (aged 18–75 years) with unresectable, locally advanced, recurrent or metastatic ESCC who had not received prior systemic treatment were randomly assigned 2:1 to receive either 1,200 mg sugemalimab or placebo, plus chemotherapy (cisplatin plus 5-fluorouracil) every 3 weeks for up to six cycles. The study met dual primary endpoints at the prespecified interim analysis. Compared with placebo, sugemalimab plus chemotherapy significantly prolonged progression-free survival (median 6.2 versus 5.4 months, HR 0.67 (95% CI 0.54–0.82); P = 0.0002) and overall survival (median 15.3 versus 11.5 months, HR 0.70 (95% CI 0.44–0.90); P = 0.0076) in treatment-naive patients with advanced ESCC. The incidence of grade 3 or higher treatment-related adverse events was similar across the two groups.

一项多中心、随机、双盲 III 期试验报告了舒格利单抗（一种 PDL1 抗体）联合化疗治疗晚期食管鳞状细胞癌 (ESCC) 的积极结果。

总共 540 名患有不可切除、局部晚期、复发或转移性 ESCC 且未接受过全身治疗的成人（年龄 18-75 岁）以 2:1 的比例随机分配，接受 1,200 mg 舒格利单抗或安慰剂，加化疗（顺铂加 5 -氟尿嘧啶）每 3 周一次，最多六个周期。该研究在预先指定的中期分析中达到了双重主要终点。与安慰剂相比，舒格利单抗联合化疗显着延长了无进展生存期（中位 6.2 个月与 5.4 个月，HR 0.67 (95% CI 0.54–0.82)；P  = 0.0002）和总生存期（中位 15.3 个月与 11.5 个月，HR 0.70 (95% CI)）。 CI 0.44–0.90）；P =  0.0076）在未经治疗的晚期食管鳞癌患者中。两组中 3 级或以上治疗相关不良事件的发生率相似。