主要研究结果:
• 纳武利尤单抗联合化疗组359例,安慰剂联合化疗组358例
• 化疗方案为医师选择SOX或CAPOX
• 数据截止时(2021/5/10),纳武利尤单抗组与安慰剂组分别有17例与6例患者继续研究治疗
• 纳武利尤单抗组的PFS(中心评估)长于化疗组(10.94 vs. 8.48个月,HR=0.67; 95%CI:0.55-0.82)
• 纳武利尤单抗组与安慰剂组的OS无差异,中位分别为17.45与17.15个月(HR=0.89; 95%CI:0.75-1.05)
• OS的界标分析:纳武利尤单抗组更好
• 纳武利尤单抗组的CR患者中约80%在3年时仍然存活
• 纳武利尤单抗组未观察到新的安全性信号或重大的晚期TRAE
参考文献:
Boku N, Omori T, Shitara K, Sakuramoto S, Yamaguchi K, Kato K, Kadowaki S, Tsuji K, Ryu MH, Oh DY, Oh SC, Rha SY, Lee KW, Chung IJ, Sym SJ, Chen LT, Chen JS, Bai LY, Nakada T, Hagihara S, Makino R, Nishiyama E, Kang YK. Nivolumab plus chemotherapy in patients with HER2-negative, previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: 3-year follow-up of the ATTRACTION-4 randomized, double-blind, placebo-controlled, phase 3 trial. Gastric Cancer. 2024 Aug 20. doi: 10.1007/s10120-024-01535-0. Epub ahead of print. PMID: 39162872.