新功能、新界面、新体验,扫描即可下载生物谷APP!
首页 » 礼来 » 礼来单抗药ramucirumab III期肺癌研究达主要终点

礼来单抗药ramucirumab III期肺癌研究达主要终点

来源:生物谷 2014-02-20 22:00

2014年2月20日讯 /生物谷BIOON/ --礼来(Eli Lilly)2月19日宣布,实验性单抗药ramucirumab全球性III期REVEL研究达到了改善总生存期的主要终点。该项研究在非小细胞肺癌(NSCLC)患者中开展,将ramucirumab联合化疗用于患者的治疗。研究数据表明,与安慰剂+紫杉醇(docetaxel)对照组相比,ramucirumab+紫杉醇治疗组总生存期(OS)表现出统计学意义的显著改善,同时疾病无进展生存期(PFS)也表现出了统计学意义的显著改善。

REVEL是一项全球性、随机、双盲研究,在既往经铂为基础的化疗方案治疗失败后病情恶化的局部晚期或转移性非小细胞肺癌(NSCLC)患者中开展,将ramucirumab+紫杉醇疗法与安慰剂+紫杉醇治疗进行了对比。

礼来计划在即将到来的科学会议上公布REVEL研究的数据,并在2014年提交ramucirumab的首个监管申请。此前,FDA已于2013年10月授予ramucirumab优先审查资格。

关于Ramucirumab

Ramucirumab是一种全人源化IgG1单克隆抗体,是一种受体拮抗剂,靶向结合于血管内皮生长因子(VEGF)受体2的胞外域,从而阻断血管内皮生长因子配体(VEGF-A,-C,-D)的相互作用,并抑制受体激活。

Ramucirumab由礼来于2008年耗资65亿美元收购ImClone公司后获得,目前正在开展相关临床试验,评估该药作为单药疗法及与其他抗癌药物的联合疗法,用于治疗乳腺癌、胃癌、非小细胞肺癌、大肠癌、肝癌、膀胱癌、尿道癌、输尿管癌、肾盂癌、前列腺癌、卵巢癌、多形性成胶质细胞瘤。目前乳腺癌、大肠癌、胃癌、肝癌、肺癌已处于III期临床开发。(生物谷Bioon.com)

英文原文:Lilly Announces Ramucirumab Phase III Lung Cancer Trial Meets Primary Endpoint of Overall Survival

-- Ramucirumab Improved Survival in Second-Line Study of Patients with Non-Small Cell Lung Cancer --

INDIANAPOLIS, Feb. 19, 2014 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the REVEL trial, a global Phase III study of ramucirumab in combination with chemotherapy in patients with second-line non-small cell lung cancer (NSCLC), showed a statistically significant improvement in the primary endpoint of overall survival in the ramucirumab-plus-docetaxel arm compared to the control arm of placebo plus docetaxel. REVEL also showed a statistically significant improvement in progression-free survival in the ramucirumab arm compared to the control arm.

The global, randomized, double-blind REVEL trial compared ramucirumab and docetaxel to placebo and docetaxel in NSCLC patients whose disease has progressed after failure of prior platinum-based chemotherapy for locally advanced or metastatic disease. The study included nonsquamous and squamous NSCLC patients. The most common ( > 5% incidence) Grade > 3 adverse events occurring at a higher rate on the ramucirumab-plus-docetaxel arm compared to the control arm were decreased white blood cell count (neutropenia/leukopenia), febrile neutropenia, fatigue/asthenia and hypertension.

"We are pleased with these Phase III data of ramucirumab in non-small cell lung cancer, which accounts for most cases of lung cancer - the leading cause of cancer-related mortality worldwide. Despite currently available therapies, there continues to be a need for new second-line treatment options for patients with lung cancer," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "REVEL is the first positive Phase III study of a biologic in combination with chemotherapy to demonstrate improved overall survival compared to chemotherapy alone in second-line non-small cell lung cancer."

Lilly plans to present data from the REVEL trial at an upcoming scientific meeting and intends to submit the first application of these data to regulatory authorities in 2014.

Dr. Gaynor added, "These data reinforce our confidence in the overall ramucirumab development program, in which we have several Phase III and earlier-phase studies in multiple tumor types, both as a single agent and in combination with other therapies. Moreover, these data underscore Lilly's continued leadership in thoracic oncology."

Notes to Editor

About the REVEL trial

REVEL is a global, double-blind, placebo-controlled Phase III study of ramucirumab and docetaxel compared to placebo and docetaxel in NSCLC patients whose disease has progressed after failure of prior platinum-based chemotherapy for locally advanced or metastatic disease. Initiated in 2010, the global study enrolled more than 1,200 patients across 26 countries. The primary endpoint of the REVEL trial is overall survival and secondary endpoints include: progression-free survival; objective response rate; quality of life; and safety. The study included nonsquamous and squamous NSCLC patients.

About Lung Cancer

Lung cancer is the leading cause of cancer death in the U.S. and most other countries, killing nearly 1.6 million people worldwide each year.[i] In the U.S., lung cancer is responsible for nearly 30 percent of all cancer deaths, more than those from breast, colon and prostate cancers combined.[ii] Stage IV NSCLC is a very difficult-to-treat cancer and the prognosis for patients with NSCLC is poor when locally advanced or metastatic.[iii] NSCLC is much more common than other types of lung cancer, and accounts for 85 percent of all lung cancer cases. Patients with squamous cell carcinoma represent about 30 percent of all patients affected by NSCLC, while non-squamous patients represent about 70 percent.[iv]

About Ramucirumab

Ramucirumab (IMC-1121B) is designed to directly inhibit angiogenesis, a process by which blood vessels supply blood to tumors. Ramucirumab is a human, receptor-targeted antibody that specifically blocks the vascular endothelial growth factor (VEGF) receptor 2 and inhibits downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.

Ramucirumab, which Lilly gained through its 2008 acquisition of ImClone Systems, is being investigated in clinical trials as a single agent and in combination with other anticancer therapies for the treatment of multiple tumor types. The REVEL lung cancer trial is the third positive Phase III study of ramucirumab; all three of those studies demonstrated improved overall survival and progression-free survival. The first, which studied ramucirumab in gastric cancer as a single agent, is the basis for regulatory submissions in the U.S. and EU; the second, which studied ramucirumab in gastric cancer in combination with paclitaxel, is a planned regulatory submission in 2014. Top-line results for Phase III trials of ramucirumab in hepatocellular (liver) and colorectal cancer are expected in 2014.

温馨提示:87%用户都在生物谷APP上阅读,扫描立刻下载! 天天精彩!


相关标签

最新会议 培训班 期刊库