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第一三共终止nimotuzumab III期鳞细胞肺癌研究

2014年4月26日讯 /生物谷BIOON/ --第一三共制药(Daiichi Sankyo)4月25日宣布,终止在日本开展的有关尼妥珠单抗(nimotuzumab,DE-766)治疗鳞状细胞肺癌的III期试验。

该III期试验是一项多中心、随机、双盲、安慰剂对照试验,调查了nimotuzumab作为一线疗法用于不可切除性和局部晚期鳞状细胞肺癌(squamous cell lung cancer)的治疗。研究中,患者随机接受nimotuzumab+同步放化疗或安慰剂+同步放化疗。

该项研究的终止,是基于最近独立数据监测委员会(DMC)提出的建议。该委员会在接受顺铂(cisplatin)+长春瑞滨(vinorelbine)+放疗+nimotuzumab联合治疗组的一些患者中观察到了安全性问题。

关于不可切除性和局部晚期鳞状细胞肺癌

在日本,肺癌是癌症致死的第一大病因。2011年约有7万人死于肺癌。非小细胞肺癌(NSCLC,包括腺癌、鳞癌、大细胞癌)占肺癌的80%以上。同步放化疗(concurrent chemoradiotherapy)是一种新的综合治疗模式,是目前用于III阶段局部晚期NSCLC的标准治疗方案,该阶段的患者不能通过手术根治,但通过放疗是可能的。在这些病例中,30%-40%为鳞细胞癌和表皮生长因子受体(EGFR)过表达。

关于泰欣生(尼妥珠单抗,nimotuzumab)和EGFR:

泰欣生(尼妥珠单抗,nimotuzumab)是全球首个以人表皮生长因子受体(EGFR)为靶点的人源化单克隆抗体,特异靶向于EGFR,该药由古巴CIMAB公司生产。在我国,泰欣生由中国和古巴合资的生物医药高新技术企业——百泰生物药业有限公司生产。nimotuzumab能够阻断表皮生长因子(EGF)对其受体的结合,从而干扰细胞信号传导。

目前,nimotuzumab已获一些国家批准,用于头颈部癌、神经胶质瘤、食道癌,并已用于全球29个已完成和26个正在开展的临床试验中,在这些试验中,迄今为止未发生任何重大安全问题。目前已知,EGFR在多种肿瘤中过表达。EGFR的过表达与转移增加、存活率下降、预后不良相关,暴露于辐射可激活EGFR。

2006年,第一三共制药从古巴CIMAB公司和加拿大CIMYM生物科技公司获得nimotuzumab在日本的开发和商业化权利。(生物谷Bioon.com)

英文原文:Daiichi Sankyo Announces Discontinuation of Phase 3 Clinical Trial in Japan of Nimotuzumab (DE-766) in Lung Cancer

TOKYO, Japan (April 25, 2014) - Daiichi Sankyo Company, Limited announced today the discontinuation of the phase 3 clinical trial conducted in Japan for nimotuzumab (DE-766) in Lung Cancer.
 
The phase 3 clinical trial was a multicenter, randomized, double-blind, placebo-controlled study investigating nimotuzumab for first-line therapy in patients with unresectable and locally advanced squamous cell lung cancer. Patients received either nimotuzumab in combination with concurrent chemoradiotherapy or a placebo in combination with concurrent chemoradiotherapy.
 
The study was discontinued based on the recent recommendation of the Independent Data Monitoring Committee which observed safety issues in certain patients who received a combination of cisplatin, vinorelbine, radiotherapy, and nimotuzumab.
 
About Unresectable and Locally Advanced Squamous Cell Lung Cancer
In Japan, lung cancer is the first leading cause of cancer death with about 70,000 deaths in 2011.i Non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, and large cell carcinoma) occupies more than 80 percent of lung cancer. Concurrent chemoradiotherapy for a radical cure is currently used as the standard treatment for patients with stage III locally advanced non-small cell lung cancer, in which radical surgery is not possible but radiotherapy is.ii Of these cases, between 30 and 40 percent are squamous cell carcinoma and EGFR is known to be overexpressed.iii
 
About Nimotuzumab and EGFR
Nimotuzumab is an intravenously administered recombinant humanized monoclonal antibody directed against human Epidermal Growth Factor Receptor (EGFR) and is produced by CIMAB S.A. (Cuba). nimotuzumab blocks the binding of Epidermal Growth Factor (EGF) to its receptor interfering with the cell signaling pathway. Nimotuzumab has been approved for head and neck cancer, glioma, and esophageal cancer in several countries and used in 29 completed and 26 on-going trials worldwide without any major safety concern so far.  EGFR is known to be overexpressed in a wide variety of human tumors.iv Overexpression of EGFR in tumors correlates with increased metastasis, decreased survival, and a poor prognosis. It is known that EGFR is activated by exposure to radiation.
In 2006, Daiichi Sankyo introduced nimotuzumab from CIMAB S.A. and CIMYM BioSciences Inc. (Canada) and has the rights to develop and commercialize in Japan.

关键词:第一三共制药,非小细胞肺癌,鳞状细胞肺癌,尼妥珠单抗,nimotuzumab,泰欣生

信息来源:生物谷