ASCO 2021:摘要概览与展望21:zenocutuzumab治疗晚期胰腺癌、NRG1融合实体肿瘤的有效性和安全性

2021-06-05 K.K MedSci原创

NRG1基因融合是一种罕见但是强有力的癌症驱动因素,常常出现在胰腺癌、肺癌和其他实体瘤中。

NRG1基因融合是一种罕见但是强有力的癌症驱动因素,常常出现在胰腺癌、胰腺癌其他实体瘤中。大部分的胰腺癌为胰腺导管腺癌,据估计,NRG1在胰腺导管腺癌中的发生率约为0.5%-1.5%。它与HER3结合,导致HER2/HER3异质化和致癌转化。

HER3 属于人表皮生长因子受体 (HER) 家族。作为 HER 家族的独特成员,HER3 缺乏内在的酪氨酸激酶活性,它经常与癌细胞中的其他受体酪氨酸激酶 (RTK) 共表达并形成异二聚体,以激活致癌信号。已经在多种人类癌症中观察到 HER3 的过度表达,并且与实体瘤患者的生存期较差有关。 zenocutuzumab 是一款新型的双特异性抗体药物,可以强力结合HER2和HER3受体,从而阻断HER3和其配体NRG1的相互作用。

入选患者(pts)患有晚期NRG1+胰腺癌、非小细胞肺癌(NSCLC)和其他实体瘤,之前接受过标准治疗,年龄≥18岁,ECOG体能状态≤1,有足够的器官功能,有可预见疾病(RECIST v1.1)。zenocutuzumab剂量:每2周静脉注射750毫克,直到病情有进展或出现不可接受的毒性。临床主要终点:研究者评估客观反应率(ORR)。次要终点:由放射学家的审查ORR、反应持续时间(DOR)和药物安全性。检测手段:每8周进行一次肿瘤成像。

51名患有NRG1+的癌症患者已经接受了zenocutuzumab治疗,其中37人参加了eNRGy研究,14人参加了EAP研究。截至2021年1月12日,27/51例患者正在接受治疗(8/13例胰腺癌,10/25例NSCLC,9/13例其他实体肿瘤)。

在这51名患者中,有10名胰腺癌患者,18名NSCLC患者和5名其他实体瘤患者,都有可预见疾病。10名胰腺癌患者中,中位年龄为49岁,50%为男性,所有患者都有转移性病变且为KRAS野生型。KRAS基因可以是没有发生突变的正常状态(称为野生型,占60%左右)或发生突变的异常状态(突变型,占40%左右)。

经研究者评估胰腺癌患者ORR为40%(4/10),7/10的患者出现了肿瘤消退,疾病控制率为90%。9/9(100%)患者的CA 19-9肿瘤标志物下降大于50%。在NRG1+人群中,33例患者中有25例观察到肿瘤消退,33例患者中有9例观察到ORR 27%,包括之前接受过阿法替尼的患者。zenocutuzumab的耐受性良好,没有患者因毒性而减少剂量。在所有队列中,就不良事件而言,≤5%的患者报告了3级事件,没有心脏毒性和严重的胃肠道或皮肤毒性事件。

在转移性KRAS野生型NRG1+胰腺癌患者中,zenocutuzumab诱导了主要放射性肿瘤消退和生物标志物反应,且引发的毒性最小。zenocutuzumab是NRG1+癌症患者的一种新型靶向治疗策略。临床试验信息:NCT02912949

原文出处:

https://meetinglibrary.asco.org/record/195781/abstract

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    2022-01-03 quxin068
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    2021-08-08 snf701207
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    2021-06-06 ms5000001360749447

    0

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    2021-06-06 weiz
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    2021-06-06 licz0427

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