科伦药业(002422.SZ)披露创新药物A166于ASCO官网上公布研究结果摘要
格隆汇5月21日丨科伦药业(002422.SZ)公布，公司董事会获悉，公司控股子公司四川科伦博泰生物医药股份有限公司开发的创新药物A166(一种抗HER2抗体-药物偶联物)将于2021年美国临床肿瘤学会年会([2021年ASCO年会])公布中国患者的I期研究结果(壁报讨论)。
2021年美国临床肿瘤学会(ASCO)年会将于6月4-8日在线举办。ASCO年会是全球肿瘤领域最权威和最受期待的学术盛会之一，每年年会的论文交流分为口头汇报(oral)、壁报讨论(poster discussion)、壁报展示(poster)和摘要发表(publication)4个等级。本次大会，科伦药业A166(HER2-ADC)中国I期临床研究以壁报讨论形式被收录，这是A166第2次在ASCO年会展示研究数据。摘要已于2021年5月19日下午五时正(东部时间)公布，演讲视频和电子材料将于2021年6月4日下午九时正(中部时间)于http://conferences.asco.org/am/公布。研究结果概要如下：
A166治疗HER2表达局部晚期或转移性实体瘤患者的I期临床研究(PhaseIstudy of A166 in patients with HER2-expressing locally advanced or metastatic solid tumors.)
该项研究是一项评估A166治疗HER2表达的局部晚期或转移性实体瘤患者的安全性、耐受性、药代动力学（PK）和初步疗效的I期临床研究，分为剂量递增和剂量扩展两个阶段。剂量递增阶段患者接受0.1、0.3、0.6、1.2、2.4、3.6、4.8、6.0mg/kg每三周一次(Q3W)的A166治疗，根据所获得的安全性、PK和初步疗效数据在第二阶段推荐剂量4.8和6.0mg/kg剂量下进行剂量扩展研究。
截至2020年11月30日共入组57例患者，中位年龄53岁，HER2阳性(IHC 3+，或2+且ISH+)患者51人，HER2低表达(IHC 1+，或2+且ISH-)患者6人，61.4%(35/57)的患者既往接受过至少5线方案的治疗。
安全性：剂量递增阶段未观察到剂量限制性毒性(DLT)。整个研究中，96.5%(55/57)的患者出现与研究药物相关的不良事件(TRAEs)，≥3级TRAEs发生率为31.6%(18/57)。常见的TRAEs包括角膜上皮病变(73.7%)、视物模糊(59.6%)、外周神经病变(26.3%)、干眼症(21.1%)、贫血(19.3%)、低钠血症(19.3%)。常见的≥3级TRAEs包括角膜上皮病变(17.5%)、低磷血症(5.3%)、干眼症(5.3%)。4例患者发生严重不良事件(SAE)，2例与研究药物可能有关，分别是血栓栓塞和乏力。1例患者因疾病进展导致死亡。
疗效：36例可疗效评估的HER2阳性乳腺癌患者的ORR分别为59.1%(13/22)和71.4%(10/14)；4例可疗效评估的HER2低表达乳腺癌患者结果为1例PR，2例SD和1例PD。目前中位PFS尚未达到，当前披露数据的患者仍有59%在继续接受治疗，提示患者仍在受益。4.8mg/kg剂量组中1例患者接受A166治疗已超过19个月。
结论：A166在血液循环中稳定性高，符合预期设计，整体耐受性、安全性良好，无间质性肺炎和明显的骨髓抑制及胃肠道毒性，在经过多线抗HER2治疗后的HER2阳性乳腺癌患者中显示出具有临床意义且较优的抗肿瘤活性，预期可为HER2阳性乳腺癌患者提供一种高效低毒的治疗新选择。
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