Oncomine Comprehensive Assay V3(OCAV3)作为赛默飞NGS肿瘤解决方案中的明星产品,与美国NCI和ECOG-ACRIN保持长期的合作。NCI-MATCH自2015年启动至今,OCAV3已经在美国完成超过6600例样本的检测,检测成功率超过93%。
且自2017年起,NIH进一步启动了儿童肿瘤相关的MATCH项目——NCI-Children’s Oncology Group Pediatric MATCH Trial (NCI-COG Pediatric MATCH),该项目针对1-21岁的儿童和青少年,患有难治性或复发性实体瘤、非霍奇金淋巴瘤或组织细胞疾病,在美国COG 接受治疗的患者纳入该多中心Ⅱ期临床试验。从石蜡包埋的肿瘤样本中提取DNA 和RNA,使用涵盖针对多种肿瘤靶向药物的161 个基因的Oncomine 肿瘤基因试剂盒进行测序,以检测基因突变、扩增和融合。应用免疫组化(IHC)检测SMARCB1、SMARCA4、PTEN 的表达缺失。基于现有的临床和临床前数据得到的“可靶向的基因突变”(aMOI)被用于确定患者的治疗资格。
临床试验信息可在https://www.clinicaltrials.gov/进行查询
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目前该项目涉及了
10个单臂临床试验项目:
APEC1621A: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of LOXO-101 in patients with tumors harboring actionable NTRK fusions.
APEC1621B: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of JNJ-42756493 (erdafitinib) in patients with tumors harboring FGFR1/2/3/4 alterations.
APEC1621C: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of tazemetostat for patients with tumors harboring alterations in EZH2 or members of the SWI/SNF complex
APEC1621D: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of LY3023414 in solid tumors
APEC1621E: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)– Phase 2 subprotocol of selumetinib in patients with tumors harboring activating MAPK pathway mutations
APEC1621F: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 subprotocol of ensartinib in patients with tumors harboring ALK or ROS1 genomic alterations
APEC1621G: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 subprotocol of vemurafenib in patients with tumors harboring actionable BRAF V600 mutations
APEC1621H: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of olaparib in patients with tumors harboring defects in DNA damage repair genes
APEC1621I: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 subprotocol of palbociclib in patients with tumors harboring activating alterations in cell cycle genes
APEC1621J: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 subprotocol of BVD-523FB (ulixertinib) in patients with tumors harboring activating MAPK pathway mutations
2019年ASCO上也公布了
最新的进展:
2017.07.24-2018.12.31,共有422 例患者从全美93 个儿童肿瘤组织登记入组。实体瘤患者占71%(n = 300),中枢神经系统肿瘤占24%(n = 101),淋巴瘤/组织细胞疾病占5%(n = 21)。390 例患者可获得肿瘤样标本,370 例(95%)送检测序,其中357 例(92%)测序结果可用。在112 例(29%;95% CI 24%~33%)患者中鉴定出可靶向的基因突变(aMOI),包括针对10 种靶向药物之一的突变、融合或基因拷贝数改变,其中95 名患者(24%;95% CI 20%~29%)符合条件被分配至可用的10 种靶向疗法之一的临床研究中,39 名患者(10%;95% CI7%~13%)已经在试验中接受了靶向治疗。共有11%的患者(n = 41)检测到MAPK 信号通路改变,其中最常见的是HRAS、KRAS、NRAS 突变(n = 16),BRAF 突变或融合(n = 14)及NF1 突变(n = 11)。其他与复发相关的基因包括SMARCB1 (n = 14), ALK (n = 8), CDK4 (n = 8), PIK3CA (n = 7), PTEN (n = 7), FGFR1 (n = 5) 和BRCA1/BRCA2 (n = 5)。
更多详细信息请参考以下链接:
http://abstracts.asco.org/239/AbstView_239_268315.html
https://clinicaltrials.gov/ct2/show/NCT03155620
https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCT03155620&r=1
https://www.seattlecca.org/clinical-trials/lymphoma-nct03155620
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