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KRAS突变靶向药物AMG510即将进入中国开展临床试验

2020-03-31 MedSci MedSci原创

KRAS突变AMG510
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在过去的10至15年中，癌症基因组测序的发展已鉴定出许多致癌基因，比如EGFR,ALK,NTRK,MET,BRAF....然而，作为人类癌症中最常出现突变的致癌基因-KRAS基因，从最初发现至今的30

在过去的10至15年中，癌症基因组测序的发展已鉴定出许多致癌基因，比如EGFR,ALK,NTRK,MET,BRAF....然而，作为人类癌症中最常出现突变的致癌基因-KRAS基因，从最初发现至今的30多年里，还没有一款直接针对KRAS突变的靶向药物。一度KRAS认为这个靶点不可以成药！
而在2019年，针对KRAS这一靶点的抑制剂AMG510终于攻破了这一堡垒，让”不可成药“的魔咒将成为历史。这款有望攻克KRAS的抗癌新星已经来到中国，即将正式开展临床试验。3月9日，CDE（国家药监局药品审评中心）官网公布，安进公司研发的KRAS G12C抑制剂AMG 510准备在中国申请临床试验。
KRAS克星现世！疾病控制率达100%！
经过30年的不懈努力，2019年，一款针对KRAS G12C这一特定的亚突变靶点的药物疗法迅速火遍了肿瘤界和病友圈，登上了Nuture等顶级期刊，并在ASCO,AACR肿瘤学盛会上发表，取得了突破性的成就，可使小鼠肿瘤消失，并使肺癌患者的肿瘤缩小，虽然这些药物还未确定是否能增加癌症患者的寿命，但目前已公布的数据足以让医学界振奋。
  • 经过三十年的研究，AMG 510是第一个达到临床阶段的KRAS G12C抑制剂！
  • 首次人体结果显示KRAS突变实体瘤的初步安全性，耐受性数据和抗肿瘤活性！
FDA已经授予了AMG 510孤儿药物指定用于KRASG12C阳性非小细胞肺癌和结肠直肠癌，在肺癌中20%的KRAS存在G12C突变，AMG510打开了历史性的缺口，让我们看到了希望。
首次人体试验，Ⅰ期临床研究（NCT03600883），29例KRAS G12C突变实体瘤可供评估，其中10例非小细胞肺癌，19例肠癌等实体瘤。
 
重点是，在10例NSCLC患者中，ORR创下史上新高，达到50%，而疾病控制率更是满分100%！对于无药可用的KRAS突变NSCLC患者，AMG510将来来逆转奇迹！5例部分缓解的患者仍在继续服药中（7.3-27.4周），最长的已经超过27周。
AMG510耐受性非常好，主要不良反应为食欲下降、腹泻、乏力、头痛、咳嗽、潮热和恶心，没有发现剂量限制毒性和与药物有关的4级以上不良反应。

 

一位为55岁男性NSCLC患者，既往尝试了几乎所有的治疗方案，（包括化疗、厄洛替尼、PD1、dasatinib、M3541）均以失败告终，后用AMG510（360mg），肿瘤缩小了67%，并且在用药18周时达到完全缓解，病灶已经消退到无法测量。

研究人员报告说，除阻断KRAS（G12C）蛋白外，AMG510还刺激称为T细胞的免疫细胞攻击肿瘤。
此前的小鼠试验中，研究人员发现AMG510的效力是原始药物的十倍！
当与PD-1抑制剂（可消除T细胞的制动作用）组合使用时，10只小鼠中的9只肿瘤都消失了。更重要的是，联合治疗似乎避免了癌症复发。在通过这种组合治愈的小鼠中，其免疫系统阻止了新植入的KRAS G12C突变癌细胞的生长。还防止了带有不同KRAS突变（称为G12D）的新植入癌细胞的生长。 
 
我们期待这款药物尽快取得进一步的临床数据，同时希望国内的临床试验的开展能给更多患者带来全新的希望。癌症难以攻克的堡垒-Kras基因
KRAS突变是最致命的癌症生长和发展的初始驱动遗传因子之一。表现出这种突变的患者通常预后较差，并且对护理标准治疗的抵抗力很差。据统计，KRAS基因突变出现在近：
90%的胰腺癌中，
30-40%的结肠癌中，
15-20%的肺癌中（大多为非小细胞肺癌）。
尽管几十年前研究人员就已经将KRAS确定为癌症的重要治疗靶点，但长期以来人们一直认为它是一种“不可摧毁的”蛋白质。这是因为这种蛋白质缺乏明显的靶点可以让小分子药物可以结合并损害其功能。
KRAS突变会产生连续生长信号，在信号传导途径的链反应中从一种蛋白质传递到下一种蛋白质。
超过六种信号通路来自KRAS，如果一个受损，其他的可以修复或规避它。
这可能是为什么阻断一种KRAS信号通路的药物可以减缓癌细胞的生长，但通常不能杀死它们。
近期，研究发现，KRAS G12C是一种特定的亚突变，是非小细胞肺癌腺癌中最常见的个体KRAS突变，占14％，大肠腺癌占5％，胰腺癌占2％。

KRAS G12C突变频率

AMG510就是专门这种突变亚型的。最初是在2013年被研发，是首个进入临床试验的KRAS抑制剂。AMG 510具有很高的选择性，仅与6,000多种蛋白质中的KRAS G12C结合，并且迄今为止在临床研究中没有发现剂量限制性毒性。

直击KRAS，众多好药在路上！

关于AMG510，目前国际上有两项临床试验正在招募，一项是针对KRAS p.G12C突变的晚期实体瘤，另一项是AMG 510结合免疫检查点抑制剂（PD-1）治疗晚期实体瘤，所以做过检测的患者快去看看你的报告里有没有KRAS p.G12C突变，在过去，医生或许只能遗憾的告诉你，这个突变目前没有任何药物可用，但是现在，已经有众多好药即将让它乖乖投降。

MRTX849
另一家公司Mirati在AACR期刊《癌症发现》上的一篇论文中也报告了令人鼓舞的人类成果。其KRAS（G12C）抑制剂MRTX849使六名肺癌患者中的三名以及四名结肠癌患者中的一名肿瘤缩小。
羟氯喹联合曲美替尼
除了Mirati公司的MRTX849和安进公司的AMG 510外，一种称为羟氯喹的自噬抑制剂和一种阻断MAPK途径中蛋白质的药物trametinib（曲美替尼 Mekinist）一起治疗可以减缓在移植了KRAS- 突变的人胰腺肿瘤的小鼠中肿瘤生长并延长存活时间。这项研究结果目前开展两项临床试验：一项已经招募参与者，另一项预计将在不久的将来推出。详情可致电全球肿瘤医生网医学部咨询（400-666-7998））
史上最难攻破的基因突变KRAS即将有靶向药问世，从此，无论是肺癌还是其他癌症如结直肠癌、胰腺癌等又将多了一个有治疗希望的检测靶点！我们拭目以待，期待新药早日上市，造福大众！

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    2020-09-25 tastas

    #AMG510#

    0

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    2020-04-01 ms5906905816781247

    #KRAS突变#

    0

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    2020-04-01 yinhl1978

    #KRAS#

    0

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    2020-04-01 zhouqu_8

    #AMG#

    0

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    2020-04-01 bioon7

    #RAS突变#

    0

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