智通财经APP讯，复宏汉霖(02696)公布，近日，一项比较公司自主开发的汉斯状® (斯鲁利单抗注射液)或安慰剂联合化疗(奥沙利铂+替吉奥)新辅助/辅助治疗胃癌的3期临床研究在计划的期中分析中，经独立数据监查委员会(Independent Data Monitoring Committee，“IDMC”)评估达到了无事件生存期(EFS)的主要研究终点，可支持提前申报上市。
本研究为一项在早期胃癌患者中开展的随机、双盲、多中心的3期临床研究，旨在比较汉斯状®联合化疗对比安慰剂联合化疗新辅助/辅助治疗早期胃癌患者的临床有效性及安全性。基于IDMC进行的预设期中分析结果显示，汉斯状®联合化疗对比安慰剂联合化疗显示出明显的无事件生存期(EFS)改善，达到预设的优效性标准，病理完全缓解(pCR)率为对照组的3倍以上，患者复发风险显著降低，同时安全性良好，未发现新的安全性信号。
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