智通财经APP讯，友芝友生物-B(02496)公布，公司自主研发的上皮细胞黏附分子(Ep CAM)和分化簇3(CD3)双靶向的在研双特异性抗体(Bs Ab)药物M701在中国开展的治疗晚期上皮肿瘤引发的恶性腹水的开发与临床试验结果已于国际知名医学期刊《实验血液学与肿瘤学》上发表。此举标志着创新疗法的临床价值获得国际医学界的认可。
II期研究旨在评估M701腹腔内输注疗法对出现中至大量恶性腹水的晚期上皮性肿瘤患者的疗效与安全性。本研究共纳入84名患者，其中43名患者被分配至M701组，接受腹腔穿刺及腹腔内M701输注。M701组的无穿刺生存时间中位数为75天，对照组则为25天，两组存在显著差异(p=0.0065)。亚组分析显示，不同类型的癌症(包括胃癌、结直肠癌及卵巢癌)均能从M701输注中获益。基线相对淋巴细胞计数较高(≥13%)的患者获得较佳疗效。与对照组患者相比，M701组患者的总生存时间获得延长。两组患者的6个月存活率分别为33.3%与12.1%。在M701组别中未观察到任何其他严重不良反应事件。
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