2014年6月5日訊 /生物谷BIOON/ --勃林格殷格翰（Boehringer Ingelheim）近日公布了抗癌藥物Giotrif（atatinib）2項III期研究（LUX-Lung 3和LUX-Lung 6）的新分析數據。這些數據證實，對於攜帶最常見突變類型——表皮生長因子受體（EGFR）突變（外顯子19缺失，del19）的非小細胞肺癌（NSCLC）患者群體，與採用化療相比，採取Giotrif作為一線治療，能夠使患者總生存期延長1年以上。
Del19是EGFR突變中最常見的類型，約佔所有EGFR突變的50%。EGFR突變的發病率，在亞洲肺腺癌患者群體中約佔40%，在白人肺腺癌患者群體中約佔10-15%。在LUX-Lung 3研究中，對於攜帶del19突變的NSCLC患者群體，與化療相比，Giotrif使總生存期延長了12.2個月；在LUX-Lung 6研究中，Giotrif使總生存期延長了13.0個月。
這些數據支持了將Giotrif用於del19 NSCLC患者的一線治療。Giotrif也是首個在這一患者群體中表現出總生存期（OS）利益的個性化治療藥物。此前，Giotrif已獲歐盟和FDA批准，該藥的獲批是基於疾病無進展生存期（PFS）數據。
關於Giotrif（atatinib）：
Atatinib適用於獨特類型EGFR突變陽性（del19和L858R）非小細胞肺癌（NSCLC）的治療，該藥已獲歐盟、日本、中國臺灣、加拿大批准，商品名為Giotrif，在美國的商品名為Gilotrif。
目前，勃林格殷格翰正在III期研究中調查atatinib用於鱗癌頭頸部癌及其他類型癌症的治療。
Afatinib是勃林格殷格翰首個腫瘤學藥物，是首個不可逆ErbB家族阻斷劑，該藥積極的臨床證據，加上全新的作用模式，使其成為一種傑出的治療選擇，有望為肺癌患者提供其急需的臨床需求。
英文原文：New data show Giotrif® (afatinib) provided more than one year additional survival for lung cancer patients with the most common type of EGFR mutation (del19) compared to chemotherapy
• Non-small cell lung cancer (NSCLC) patients with the del19 EGFR mutation lived a median of more than one year longer if they started treatment with afatinib rather than standard chemotherapy1
• Afatinib is the first treatment to demonstrate an overall survival benefit for patients with specific types of EGFR mutation-positive NSCLC1
Ingelheim, Germany, Monday, June 2 – Boehringer Ingelheim today announced results of the pre-specified individual, as well as the exploratory combined, analyses of two Phase III trials (LUX-Lung 3 and LUX-Lung 6). These data, to be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), demonstrated for the first time that patients with NSCLC with the most common epidermal growth factor receptor (EGFR) mutation (exon 19 deletions; del19) lived more than one year longer if treated with first-line afatinib compared to chemotherapy.1
Del19 is the most common type of EGFR mutation. It accounts for 50% of all EGFR mutations. The prevalence of EGFR mutations is approximately 40% among Asian patients and 10-15% among Caucasian patients with lung adenocarcinoma.2,3,4 For patients with the del19 mutation afatinib prolonged survival by 12.2 months versus chemotherapy in the LUX-Lung 3 trial, and 13.0 months versus chemotherapy in the LUX-Lung 6 trial. 1
Principal investigator Professor James Chih-Hsin Yang, M.D., Ph.D., National Taiwan University Hospital in Taiwan commented: "NSCLC patients with the del19 EGFR mutation lived a median of more than one year longer if they started treatment with afatinib rather than standard chemotherapy. Afatinib is the first treatment to demonstrate an overall survival benefit for these patients.
LUX-Lung 3 and LUX-Lung 6 represent a potential change in the use of personalised medicine for treating patients with NSCLC. I think that these data support afatinib as the treatment of choice for patients with the del19 mutation."
Afatinib: approved and investigational indications
Afatinib (GIOTRIF® / GILOTRIF®) is indicated for the treatment of distinct types of EGFR mutation-positive NSCLC. Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the U.S. under the brand name GILOTRIF®. It is under regulatory review in other countries. Phase III trials in squamous head and neck cancer (HNSCC) and trials in other tumour types are ongoing.