Abstract：
UNASSIGNED: This plain language summary provides an overview of two of the main clinical studies that led to tepotinib\'s approval, the phase I first-in-human study and the phase II VISION study.
UNASSIGNED: Tepotinib is a targeted anti-cancer treatment taken orally (by mouth). It is available in many countries for people with advanced or metastatic non-small cell lung cancer (NSCLC), where the tumor contains a genetic mutation (alteration) called \'MET exon 14 skipping\'. Tumor cells rely on this mutation to grow and survive, so targeted blocking of the effect of this mutation is an important treatment approach. MET exon 14 skipping occurs in approximately 3-4% of people with NSCLC. These people are usually of older age. This subtype of NSCLC is associated with poor outcomes. Before treatments that specifically target this MET mutation were developed, only general treatments such as chemotherapy were available for this type of cancer. Because chemotherapy attacks all rapidly dividing cells in a person\'s body and is administered intravenously (through a vein), it can often cause unwanted side effects. Cancer cells grow and divide rapidly because of defects, often involving proteins called \'tyrosine kinases\'. Specific tyrosine kinase inhibitors (TKIs) were therefore developed to slow or stop cancer growth by targeting these proteins. Tepotinib is a MET TKI. This means that it blocks the activity of the MET pathway that is overactive in MET exon 14 skipping NSCLC. Doing this, may slow down cancer growth.
UNASSIGNED: In the studies summarized here, people with MET exon 14 skipping NSCLC who took tepotinib had their tumor growth stopped or their tumor shrunk for a period of time, and they mostly experienced side effects that they could tolerate. Clinical Trial Registration: NCT01014936 (tepotinib first-in-human), NCT02864992 (VISION), NCT03940703 (INSIGHT 2) (ClinicalTrials.gov).
UNASSIGNED: Tepotinib is a targeted anti-cancer treatment taken orally (by mouth). It is available in many countries for people with advanced or metastatic non-small cell lung cancer (NSCLC), where the tumor contains a genetic mutation (alteration) called \'MET exon 14 skipping\'. Tumor cells rely on this mutation to grow and survive, so targeted blocking of the effect of this mutation is an important treatment approach. MET exon 14 skipping occurs in approximately 3-4% of people with NSCLC. These people are usually of older age. This subtype of NSCLC is associated with poor outcomes. Before treatments that specifically target this MET mutation were developed, only general treatments such as chemotherapy were available for this type of cancer. Because chemotherapy attacks all rapidly dividing cells in a person\'s body and is administered intravenously (through a vein), it can often cause unwanted side effects. Cancer cells grow and divide rapidly because of defects, often involving proteins called \'tyrosine kinases\'. Specific tyrosine kinase inhibitors (TKIs) were therefore developed to slow or stop cancer growth by targeting these proteins. Tepotinib is a MET TKI. This means that it blocks the activity of the MET pathway that is overactive in MET exon 14 skipping NSCLC. Doing this, may slow down cancer growth.
UNASSIGNED: In the studies summarized here, people with MET exon 14 skipping NSCLC who took tepotinib had their tumor growth stopped or their tumor shrunk for a period of time, and they mostly experienced side effects that they could tolerate. Clinical Trial Registration: NCT01014936 (tepotinib first-in-human), NCT02864992 (VISION), NCT03940703 (INSIGHT 2) (ClinicalTrials.gov).
摘要：
■这个简单的语言摘要概述了导致特泊替尼获得批准的两项主要临床研究，I期首次人体研究和II期视觉研究。
■Tepotinib是一种口服（口服）的靶向抗癌治疗。它在许多国家/地区适用于晚期或转移性非小细胞肺癌（NSCLC）患者。其中肿瘤包含一种称为“MET外显子14跳跃”的基因突变（改变）。肿瘤细胞依靠这种突变来生长和存活，所以靶向阻断这种突变的作用是一种重要的治疗方法。MET外显子14跳跃发生在约3-4%的NSCLC患者中。这些人通常年龄较大。NSCLC的这种亚型与不良预后相关。在开发专门针对这种MET突变的治疗方法之前，只有化疗等一般治疗方法可用于此类癌症.因为化疗会攻击人体内所有快速分裂的细胞，并通过静脉给药，它通常会引起不必要的副作用。由于缺陷，癌细胞迅速生长和分裂，通常涉及称为“酪氨酸激酶”的蛋白质。因此,开发了特异性酪氨酸激酶抑制剂(TKIs)以通过靶向这些蛋白质来减缓或阻止癌症生长。Tepotinib是METTKI。这意味着它阻断了在MET外显子14跳跃NSCLC中过度活跃的MET途径的活性。这样做，可能会减缓癌症的生长。
■在这里总结的研究中，接受Tepotinib的MET第14外显子跳过NSCLC的患者肿瘤生长停止或肿瘤缩小了一段时间，他们大多经历了他们可以忍受的副作用。临床试验注册：NCT01014936（替泊替尼首次在人类中），NCT02864992(视觉),NCT03940703(INSIGHT2)(ClinicalTrials.gov)。
■Tepotinib是一种口服（口服）的靶向抗癌治疗。它在许多国家/地区适用于晚期或转移性非小细胞肺癌（NSCLC）患者。其中肿瘤包含一种称为“MET外显子14跳跃”的基因突变（改变）。肿瘤细胞依靠这种突变来生长和存活，所以靶向阻断这种突变的作用是一种重要的治疗方法。MET外显子14跳跃发生在约3-4%的NSCLC患者中。这些人通常年龄较大。NSCLC的这种亚型与不良预后相关。在开发专门针对这种MET突变的治疗方法之前，只有化疗等一般治疗方法可用于此类癌症.因为化疗会攻击人体内所有快速分裂的细胞，并通过静脉给药，它通常会引起不必要的副作用。由于缺陷，癌细胞迅速生长和分裂，通常涉及称为“酪氨酸激酶”的蛋白质。因此,开发了特异性酪氨酸激酶抑制剂(TKIs)以通过靶向这些蛋白质来减缓或阻止癌症生长。Tepotinib是METTKI。这意味着它阻断了在MET外显子14跳跃NSCLC中过度活跃的MET途径的活性。这样做，可能会减缓癌症的生长。
■在这里总结的研究中，接受Tepotinib的MET第14外显子跳过NSCLC的患者肿瘤生长停止或肿瘤缩小了一段时间，他们大多经历了他们可以忍受的副作用。临床试验注册：NCT01014936（替泊替尼首次在人类中），NCT02864992(视觉),NCT03940703(INSIGHT2)(ClinicalTrials.gov)。
