Nintedanib(BIBF1120)相关信息

LUME-Lung 1：近十年来二线治疗总生存的首次突破

*试验具体内容

       LUME Lung 1 这项III期、安慰剂对照临床研究，旨在探究Nintedanib联合多西他赛治疗一线治疗进展后的局部晚期/转移性非小细胞肺癌的疗效。

       研究纳入IIIB/IV期或复发性非小细胞肺癌患者（根据组织学，ECOG评分，贝伐单抗的使用和脑转移瘤情况分层），随机分配至Nintedanib 200mg，2/日+多西他赛 75 mg/m2，21天1周期（N = 655）或安慰剂+多西他赛（N = 659）。1°研究终点为患者的PFS，2°研究终点为总生存。

       将两组患者特征在两组间进行平衡。治疗组的PFS与安慰剂组相比显著延长（HR 0.79，CI：0.68，0.92，P = 0.0019，中位PFS为3.4比2.7个月），不论组织学分类（其中鳞状细胞癌HR 0.77，P=0.02；腺癌HR 0.77，P=0.02）。在所有腺癌患者中，总生存都显著延长（HR = 0.83，P=0.0359，中位生存为12.6对10.3个月），最大的生存改善出现在T<9mo的腺癌患者群体（HR 0.75，P= 0.0073，中位生存为10.9与7.9个月）。OS在所有患者中有改善的趋势（HR = 0.94，P =0.272，中位数为10.1比9.1个月）。腺癌患者的疾病控制率在Nintedanib联合多西他赛组显着提高（OR 1.93，P <0.0001），其中T<9mo腺癌人群OR 2.90，P <0.0001。最常见的不良反应为腹泻和ALT升高。

       由此看出，Nintedanib联合多西他赛显着改善PFS并延长OS时间。不良反应一般通过减少剂量和对症治疗来处理。

LUME-Lung 1：Nintedanib联合多西他赛二线治疗结果
*关于Nintedanib

       Nintedanib是一种三联血管激酶抑制剂，可同时阻断三种生长因子受体：血管内皮生长因子受体(VEGFR 1-3)、血小板源性生长因子受体 (PDGFRα和β)以及纤维母细胞生长因子受体(FGFR 1-3)。所有这三种受体均在新生血管的形成和维持过程（血管发生）中发挥了关键性的作用。对这些受体的阻断可带来对血管发生的抑制，而血管发生在肿瘤生长和播散中发挥了重要作用。

       目前正在针对Nintedanib应用于某些实体瘤的治疗开展研发工作，包括晚期非小细胞肺癌(NSCLC)、卵巢癌、肝癌 (肝细胞肝癌)、肾癌 (肾细胞癌)和结直肠癌。

请问YL购买途径？多谢！

二师兄 发表于 2014-7-4 17:36
下周

与化疗同时使用，要联用的

1.用于肺纤维化的剂量是150MG*2
2.BIBF1120不入脑

二师兄 发表于 2014-7-8 18:00
与化疗同时使用，要联用的

类似于阿瓦,应该可以和特等联用

Boehringer Ingelheim的特发性肺纤维化药物nintedanib获得FDA突破性疗法认定

Boehringer Ingelheim’s investigational therapy nintedanib* receives the first FDA breakthrough therapy designation in IPF

Ingelheim, Germany, 16 July 2014 – Boehringer Ingelheim today announced that for the first time the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy designation for a treatment in idiopathic pulmonary fibrosis (IPF), a devastating and fatal lung disease. Nintedanib is an investigational therapy currently under FDA and European Medicines Agency (EMA review) for IPF.

“We’re excited nintedanib* has been granted breakthrough therapy designation in the US, which we hope will make the treatment available to IPF patients as quickly as possible. Currently there are no FDA-approved treatments available for IPF. We are committed to working with all regulatory bodies to make nintedanib* available to people living with this serious and life-threatening lung disease.” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.

The Breakthrough Therapy designation process was established by the FDA in 2012. It is intended to facilitate and expedite the development and review of treatments for serious or life-threatening conditions if preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.1

IPF is a debilitating and fatal lung disease that causes permanent scarring of the lungs, difficulty breathing and decreases the amount of oxygen the lungs can supply to the major organs of the body.2 IPF affects as many as 14-43 people per 100,000 worldwide.3

Results from two global Phase III studies (INPULSIS&#8482;-1 and INPULSIS&#8482;-2) evaluating the efficacy and safety of nintedanib* for the treatment of IPF were presented at the American Thoracic Society (ATS) International Conference and published in the New England Journal of Medicine in May 2014.4

Nintedanib* is the first targeted treatment for IPF that has consistently demonstrated to slow disease progression in IPF by significantly reducing the annual decline in lung function by approximately 50%.4

This effect on disease progression was further supported in the pooled data set by a positive signal in reducing the risk of acute exacerbations by 38% (p=0.08) and a significant risk reduction in confirmed or suspected acute exacerbation by 68% (p=0.005).4

http://www.boehringer-ingelheim. ... _july_2014_ipf.html

还是很好的东西，学习了

期待更多的消息，又是一种利器

凡看到不入脑的字眼，都很失望

我家对V靶点的药不是很敏感，主要是E靶点的！