罗氏（Roche）3月3日宣布，一个独立数据监测委员会经审查后认为，因缺乏临床意义的疗效，已建议停止有关实验性单抗药MetMab（onartuzumab）的III期METLung研究。
METLung是一项III期、随机、双盲研究，在既往已接受治疗（2线或3线）的MET阳性、晚期非小细胞肺癌（NSCLC）患者中开展，调查了onartuzumab+Tarceva（特罗凯）组合疗法相对于Tarceva单药疗法的疗效和安全性，该项研究中还用到了一种伴侣诊断免疫组化（IHC）试剂盒，该试剂盒由罗氏旗下Ventana医疗系统公司开发。
罗氏称，对该项研究的结果表示失望。研究中，2组整体不良事件发生率大体相似。相关数据将提交至即将举行的医学会议。
目前，罗氏正在评估METLung研究的结果对onartuzumab整个临床项目的影响。
关于
根据世界卫生组织（WHO），据估计，2012年全球有近160万人死于肺癌，而非小细胞肺癌（NSCLC）占到了所有肺癌的85%。
关于
MET是位于细胞表面的一种蛋白，作为一种受体，能够结合肝细胞生长因子（HGF）。当HGF结合MET，能够导致MET蛋白二聚化（即形成二聚体），随即触发信号级联反应，导致细胞生长、分裂、扩散到身体的其他部位。MET信号通路的激活，已被提议为肿瘤生长和转移的一种机制。
关于
onartuzumab是一种实验性单价（monovalent）单克隆抗体，特异靶向MET受体，目前正调查用于多种癌症的治疗。
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that an independent data monitoring committee has recommended that the phase III METLung study be stopped due to a lack of clinically meaningful efficacy.
The study evaluated if onartuzumab (MetMab) in combination with Tarceva (erlotinib) helped patients with previously treated, advanced non-small cell lung cancer (NSCLC) whose tumours were identified as MET-positive live longer compared to Tarceva alone. Overall adverse event rates were generally similar between the two groups. Data will be submitted for presentation at a forthcoming medical meeting.
"These results are disappointing because new options are needed for patients with lung cancer, the most common and deadly cancer worldwide,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "We remain committed to helping patients with lung cancer and are studying several investigational medicines in this disease.”
Roche is evaluating the implications of the METLung study results across the ongoing onartuzumab clinical programme.
About the METLung Study (NCT01456325)
METLung is a Phase III, randomised, double-blind study evaluating the efficacy and safety profile of onartuzumab in combination with Tarceva in patients with previously treated (second- or third-line) advanced NSCLC identified to be MET-positive. The METLung study included a companion diagnostic immunohistochemistry (IHC) test that was co-developed with Ventana Medical Systems, Inc., a member of the Roche Group.
Four hundred and ninety-nine patients were randomized to receive 150 mg of Tarceva taken daily plus either:
Intravenous 15 mg/kg of onartuzumab every three weeks
Intravenous placebo every three weeks
The primary endpoint is overall survival. Secondary endpoints include progression-free survival, objective response rate and safety profile.
The results announced today are from a pre-specified interim analysis.
About Lung Cancer
According to the World Health Organization, it is estimated that nearly 1.6 million people worldwide died of lung cancer in 2012; NSCLC accounts for 85 percent of all lung cancers.
About the MET Pathway
MET is a protein found on the surface of cells and acts as a receptor that binds to another protein called Hepatocyte Growth Factor (HGF), also known as "Scatter Factor". When HGF binds to MET, it causes MET proteins to form pairs (dimerise), which triggers a signalling cascade that tells cells to grow, divide, and spread to other parts of the body. Activation of the MET pathway has been proposed as a mechanism of tumour growth and spread (metastasis).
About Onartuzumab
Onartuzumab, an investigational monovalent (one-armed) monoclonal antibody designed to specifically target the MET receptor, is being studied in various cancers.
About Tarceva
Tarceva is a once-daily, oral non-chemotherapy treatment for the treatment of advanced or metastatic NSCLC. It has been shown to potently inhibit epidermal growth factor receptor (EGFR), a protein involved in the growth and development of cancers. Tarceva is a registered trademark of OSI Pharmaceuticals, LLC, a member of the Astellas global group of companies.
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