AACR 2020:EGFR/HER2新药Mobocertinib用于NSCLC EGFR 20ins突变ORR达43%

2020-04-29 希望树老马 希望树

Mobocertinib(TAK-788,曾用代号AP32788)是武田制药研发的一款小分子EGFR/HER2抑制剂,日前美国FDA已授予突破性疗法认定(BTD)药物资格。2020年4月28日,AAC

Mobocertinib(TAK-788,曾用代号AP32788)是武田制药研发的一款小分子EGFR/HER2抑制剂,日前美国FDA已授予突破性疗法认定(BTD)药物资格。2020年4月28日,AACR年会报道了1/2期临床试验(NCT02716116)结果。

Mobocertinib基于奥希替尼的骨架核心改进,大大提高了对EGFR 20外显子插入突变的活性,需注意的是,幻灯片第12页中的分子式是错的,应该是图1所示。

Mobocertinib的2期标准剂量(同时也是最大耐受剂量)为160mg每天一次,口服,是否空腹影响很小。 28例可供评估的EGFR 20外显子插入突变经治NSCLC患者,客观有效率43%,中位无进展生存期7.3月。

Mobocertinib 160mg每天一次剂量组的多数不良反应为1-2级,常见不良反应有腹泻(85%,3级以上18%),恶心(43%,3级以上6%),皮疹(36%,3级以上1%),呕吐(29%,3级以上3%),食欲下降(25%,3级以上1%),口腔炎(18%,3级以上4%),脂肪酶升高(10%,3级以上6%)和淀粉酶升高(8%,3级以上4%)。因不良反应,50%的患者暂停过药物,25%的患者药物减量,14%的患者永久停药。

Mobocertinib对比培美曲塞联合铂类一线治疗EGFR 20外显子插入突变复发性或晚期NSCLC患者的三期临床试验(NCT04129502)已经开展(美国4个临床点,西班牙1个)。

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    2020-12-18 tamgche
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    2020-05-01 10518094zz
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    2020-05-01 liuyiping
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    2020-05-01 Luyuxie_14
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    2020-05-01 psybestwish
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    2020-04-29 肿肿

    NSCLC下一步突破在于新靶点了,靶向治疗和免疫治疗基本见顶了,再有新的就需要新机制了

    0

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