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礼来单抗药ramucirumab III期胃癌研究成功

来源:生物谷 2013-09-27 02:04

2013年9月26日讯 /生物谷BIOON/ --礼来(Eli Lilly)9月26日公布了有关实验性单抗药物ramucirumab(IMC-1121B)的2项国际性III期研究的数据,其中一项在晚期胃癌患者中开展,另一项在转移性乳腺癌患者中开展。

RAINBOW是一项全球性、随机、双盲III期试验,在初始化疗后病情恶化的晚期(局部晚期、不可切除性或转移性)胃癌(gastric cancer)患者中开展,将ramucirumab+紫杉醇(paclitaxel)组合疗法与安慰剂+紫杉醇进行了对比,该项研究达到了改善总生存期(OS)的主要终点,同时也达到了改善无进展生存期(PFS)的次要终点。

礼来计划将RAINBOW的数据提交至即将召开的科学会议,并打算向监管当局提交ramucirumab联合紫杉醇用于治疗晚期胃癌的监管申请。

另一项试验ROSE(TRIO-012)是一项全球性、随机、双盲III期试验,由礼来和国际癌症组织TRIO合作,在局部复发或转移性HER2阴性乳腺癌患者中开展,将ramucirumab+多西紫杉醇(docetaxel)组合疗法与安慰剂+多西紫杉醇进行了对比,该项研究未能达到改善无进展生存期(PFS)的主要终点。礼来将与TRIO共同决定ramucirumab乳腺癌研究下一步的患者招募。

目前,礼来正在开展其他相关III期研究,在大肠癌、肝癌、肺癌中评价ramucirumab,这些研究的数据预计将于2014年获得。

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 Second Positive Ramucirumab Phase III Gastric Cancer Study Meets Primary Endpoint; Phase III Lilly/TRIO Breast Cancer Study Misses Primary Endpoint
-- Additional Phase III Top-Line Results in Other Tumor Types Expected in 2014 --

INDIANAPOLIS, Sept. 26, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced top-line results from two global Phase III studies of ramucirumab (IMC-1121B), one in advanced gastric cancer and another in metastatic breast cancer.

The RAINBOW trial, a global Phase III study of ramucirumab in combination with paclitaxel in patients with advanced gastric cancer, met its primary endpoint of improved overall survival and a secondary endpoint of improved progression-free survival.

The global, randomized, double-blind RAINBOW trial compared ramucirumab and paclitaxel to placebo and paclitaxel in patients with advanced (locally advanced, unresectable or metastatic) gastric cancer that was refractory to or progressive after initial chemotherapy. The most common ( > 5% incidence) Grade > 3 adverse events occurring at a higher rate on the ramucirumab-plus-paclitaxel arm compared to the control arm included neutropenia, leukopenia, hypertension, fatigue/asthenia and abdominal pain.

"We are excited to see a second positive Phase III trial of ramucirumab in gastric cancer demonstrating an improvement in both overall survival and progression-free survival, as stomach cancer is a difficult-to-treat disease that remains a major health problem worldwide and the prognosis for patients diagnosed with advanced gastric cancer is poor," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology.

The first positive study, REGARD, showed single-agent ramucirumab improved overall survival and progression-free survival in patients with advanced gastric cancer who have had disease progression after initial chemotherapy.  There are no agents specifically approved in the U.S. or EU for advanced gastric cancer patients in this setting.

Lilly plans to present data from the RAINBOW trial at an upcoming scientific meeting and intends to submit an application for ramucirumab in combination with paclitaxel to regulatory authorities.

A separate global Phase III study of ramucirumab in women with locally recurrent or metastatic breast cancer, ROSE, did not meet its primary endpoint of progression-free survival.  This trial is being conducted with the international cancer research group TRIO (Translational Research in Oncology).


The randomized, double-blind trial, also known as TRIO-012, compared ramucirumab and docetaxel to placebo and docetaxel as a first-line treatment in patients with unresectable, locally recurrent or metastatic HER2-negative breast cancer.  The primary endpoint of progression-free survival in this study favored ramucirumab but was not statistically significant.  The interim analysis for overall survival showed no benefit for ramucirumab.  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 included fatigue/asthenia, neutropenia, febrile neutropenia, hypertension and stomatitis.

"Cancer is complex and patients with different tumor types may have varied responses due to distinct tumor biologies and individual patient characteristics.  Unfortunately, anti-angiogenic agents have not yet been able to demonstrate an overall survival benefit for patients with metastatic breast cancer," said John Mackey, MD., principal investigator of the ROSE/TRIO-012 study and professor of oncology, University of Alberta.

Lilly and TRIO will work together to determine next steps for patients enrolled in this ramucirumab breast cancer study, and plan to present data from this trial at an upcoming scientific meeting.  Lilly does not plan to submit an application to regulatory authorities for ramucirumab in the first-line treatment of locally recurrent or metastatic HER2-negative breast cancer based on the results from this study.

"We are disappointed that this breast cancer trial did not meet its primary endpoint.  However, now with two positive gastric cancer trials, Lilly remains confident in the overall ramucirumab development program. We are looking forward to additional Phase III results for ramucirumab in colorectal, hepatocellular and lung cancer, expected in 2014," said Dr. Gaynor.

Notes to Editor

About the RAINBOW trial

RAINBOW is a global, randomized, double-blind, placebo-controlled Phase III study of ramucirumab and paclitaxel compared to placebo and paclitaxel in patients with advanced (locally advanced, unresectable or metastatic) gastric cancer (including adenocarcinomas of the gastro-esophageal junction) refractory to or progressive after initial chemotherapy containing platinum and fluoropyrimidine.  Initiated in 2010, the global study randomized a total of 665 patients across 27 countries in North America, South America, Europe, Australia and Asia.  The primary endpoint of the RAINBOW trial is overall survival and secondary endpoints include: progression-free survival; time to progressive disease; objective response; quality of life; and safety.

About the REGARD trial

REGARD is a global, randomized, double-blind Phase III study of ramucirumab and best supportive care compared to placebo and best supportive care as treatment in patients with advanced gastric cancer (including adenocarcinomas of the gastro-esophageal junction) following progression after initial chemotherapy. In total, 355 patients were randomized in 29 countries.

About Gastric Cancer

Gastric cancer is the fourth most common cancer in the world and the second-leading cause of cancer-related death.[i]  There were approximately one million new cases of stomach cancer worldwide in 2008 (640,000 men, 348,000 women), with approximately 736,000 deaths (463,000 men, 273,000 women), making it the third-leading cause of cancer death globally in men and the fifth in women.[ii] Stomach cancer is more prevalent in countries outside the U.S. and EU.[iii]

Gastric cancer is a disease in which cancer cells form in the lining of the stomach. It develops slowly, usually over many years and often goes undetected.[iv] As the stomach cancer advances, it can travel through the bloodstream and spread to organs such as the liver, lungs and bones.[v]

The most common type of stomach cancer is called adenocarcinoma, which starts from one of the common cell types found in the lining of the stomach.[vi] Other types include: lymphoma, gastrointestinal stromal tumor and carcinoid tumor. [v]

About the ROSE trial and TRIO

The ROSE trial, also known as TRIO-012, is a global, randomized, double-blind Phase III study of ramucirumab and docetaxel compared to placebo and docetaxel in patients with human epidermal growth factor receptor-2 (HER2)-negative, unresectable, locally recurrent or metastatic breast cancer.  Initiated in 2008, the global study randomized a total of 1,144 patients at more than 230 sites in 23 countries.  The primary endpoint of the ROSE trial is progression-free survival and secondary endpoints include: overall survival; time to progression; percentage of participants with objective response; duration of response; immunogenicity; quality of life; and safety.

TRIO is an academic global network of investigators capable of providing rapid accrual and high quality data in oncology clinical trials. TRIO has selected dedicated investigators from around the world to participate in pivotal trials of new cancer agents in breast cancer and other cancer settings. TRIO has been successful in maintaining a strong and enthusiastic network by offering innovative and exciting science through its own translational research. TRIO also has an operations infrastructure that uses comprehensive pharmaceutical industry standards and procedures. TRIO was incorporated as a Canadian not-for-profit entity in 1999. 

About Ramucirumab

Ramucirumab 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 types of cancer. In total, there are six global Phase III trials of ramucirumab — one each in breast, colorectal, hepatocellular (liver) and lung cancer, and two in gastric (stomach) cancer.

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