Next-generation ALK inhibitors: is the median the message?,The Lancet Respiratory Medicine

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Next-generation ALK inhibitors: is the median the message?
The Lancet Respiratory Medicine ( IF 38.7 ) Pub Date : 2019-10-15 , DOI: 10.1016/s2213-2600(19)30362-5
D Ross Camidge ₁

Affiliation

Oncogenic rearrangements of the ALK gene occur in approximately 4% of non-small-cell lung cancers (NSCLCs). The first-generation ALK inhibitor crizotinib was approved by the US Food and Drug Administration for treatment of advanced ALK-positive NSCLC in 2011. Since then, three next-generation ALK inhibitors—alectinib, ceritinib, and brigatinib—have been approved for use after crizotinib. Lorlatinib has been approved for use after any of these other next-generation inhibitors; alectinib and ceritinib have been approved as first-line treatment instead of crizotinib; and there is also some preliminary positive data for brigatinib in the first-line setting. Trials are also underway of two other next-generation inhibitors, lorlatinib (CROWN, ) and ensartinib (eXalt3, ), ^, versus crizotinib for first-line treatment of ALK-positive NSCLC. In The Lancet Respiratory Medicine, Yunpeng Yang and colleagues provide phase 2 activity data for yet another ALK inhibitor, ensartinib, in the post-crizotinib setting. In the absence of direct head-to-head comparisons of this crowded field of next-generation drugs, how can these new data for ensartinib and, by extension, the potential usefulness of the drug be assessed?

中文翻译：

下一代ALK抑制剂：信息中位数是什么？

ALK基因的致癌重排发生在大约4％的非小细胞肺癌（NSCLC）中。第一代ALK抑制剂克唑替尼于2011年获得美国食品和药物管理局的批准，可用于治疗晚期ALK阳性的NSCLC。此后，三种下一代ALK抑制剂-阿ectinib，ceritinib和brigatinib已获批准使用。克唑替尼。洛拉替尼已被批准在任何其他下一代抑制剂中使用。alectinib和ceritinib已被批准为替代crizotinib的一线治疗药物；一线治疗中还有brigatinib的一些初步阳性数据。另外两种其他下一代抑制剂洛洛替尼（CROWN，）和恩沙替尼（eXalt3，）也在试验中^，与克唑替尼联合用于ALK阳性NSCLC的一线治疗。在柳叶刀呼吸医学杂志上，Yunpeng Yang及其同事提供了克唑替尼治疗后另一种ALK抑制剂恩沙替尼的2期活性数据。在没有下一代人群这一拥挤的领域的直接正面对比的情况下，如何评估恩沙替尼的这些新数据以及扩展的药物潜在用途？

更新日期：2019-12-20

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