阿斯利康启动免疫疗法MEDI4736 III期肺癌项目

关键词:阿斯利康,免疫疗法,单抗,MEDI4736,非小细胞肺癌,NSCLC,细胞程序性死亡配体,PD-L1

2014年5月9日讯 /生物谷BIOON/ --阿斯利康(AstraZeneca)5月8日宣布,启动免疫疗法MEDI4736的III期项目。MEDI4736是一种单克隆抗体,靶向细胞程序性死亡配体1(PD-L1),目前正开发用于非小细胞肺癌(NSCLC)和其他癌症的治疗。III期NSCLC项目的首个研究PACIFIC,将在已完成放化疗且无迹象表明肿瘤恶化的局部晚期、不可切除性(III阶段)非小细胞肺癌(NSCLC)患者中开展,将调查MEDI4736相对于安慰剂对疾病无进展生存期(PFS)和总生存期(OS)的改善。PACIFIC试验是MEDI4736在在这一患者群体中的首个关键研究。

MEDI4736是一种全人源化单克隆抗体,靶向细胞程序性死亡配体1(PD-L1)。来自PD-L1的信号帮助肿瘤逃避免疫系统的检查。MEDI4376能够阻断这些信号,对抗肿瘤的免疫逃避战术。目前,阿斯利康正在开发MEDI4736及其他免疫疗法(IMTS),用于增强患者的免疫系统以攻击癌细胞。

PACIFIC试验预计将在全球100多个网点招募702例患者。

阿斯利康旗下生物制剂研发部门MedImmune目前正在建设综合性的免疫肿瘤学项目,包括MEDI4736,tremelimumab,MEDI0680和MEDI6469。同时也正在一系列肿瘤类型中探索单药疗法和组合疗法。(生物谷Bioon.com)

英文原文:AstraZeneca initiates phase III immunotherapy study for MEDI4736 in patients with lung cancer

First MedImmune oncology immunotherapy targeting the PD-L1/PD-1 pathway progresses into Phase III

AstraZeneca today announced the start of the Phase III programme for MEDI4736, an immunotherapy in development for the treatment of non-small cell lung cancer (NSCLC) and other cancers. The goal of the PACIFIC trial, the first study in the Phase III NSCLC programme, is to evaluate progression free survival and overall survival of MEDI4736 compared to placebo in patients with locally advanced, unresectable NSCLC (Stage III) following completion of treatment with chemoradiotherapy and no evidence of tumour progression. The PACIFIC trial is the first pivotal study of an immunotherapy in this patient population.

MEDI4736 is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. MEDI4736 is being developed to empower the patient’s immune system and attack the cancer.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca said: “This is a significant milestone for AstraZeneca and MedImmune. MEDI4736 is an important molecule in our immuno-oncology portfolio and its entry into Phase III clinical trials is further evidence of our commitment to invest in distinctive science in our core therapy areas, and to rapidly progress our immuno-oncology pipeline. Lung cancer is still the leading cancer killer; there is a clear need for more treatment options to provide patients with a better chance of beating the disease. We believe MEDI4736, and immunotherapies more broadly, hold the potential to shape the future of cancer treatment."

A total of 702 patients are anticipated to be randomised into the PACIFIC Phase III study across more than 100 sites globally. The Phase III programme follows the evaluation of clinical activity and the safety profile of MEDI4736 in a Phase I programme. Updated information from early stage studies (monotherapy and early combination data) will be presented at this year’s American Society of Clinical Oncology annual meeting.

According to the latest statistics from the World Health Organization (WHO), lung cancer was responsible for 1.59 million deaths (nearly 20% of all deaths from cancer) in 2012. NSCLC is the most common form of lung cancer and the National Comprehensive Cancer Network guidelines estimate that around a third of patients are at Stage III of the disease when diagnosed. While the majority of NSCLC patients initially benefit from chemoradiotherapy, their cancer eventually progresses and they die of metastatic disease.

MedImmune, AstraZeneca’s biologics research and development arm, is building a comprehensive immuno-oncology programme including MEDI4736, tremelimumab, MEDI0680 and MEDI6469. It is actively exploring both monotherapy and combination therapies across a range of tumour types. As a result, the AstraZeneca oncology pipeline is well positioned to pursue both the most effective data-driven combinations of immunotherapies and combinations with highly targeted small molecules.

NOTES TO EDITORS

About MEDI4736

MEDI4736 is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. MEDI4736 is being developed, alongside other immunotherapies (IMTs), to empower the patient’s immune system and attack the cancer.

The PACIFIC clinical trial is a global study to assess the effects of MEDI4736 following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer. ClinicalTrials.gov identifier: NCT02125461.

About MedImmune

MedImmune is the worldwide biologics research and development arm of AstraZeneca. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres.

(责任编辑:yangsumin)

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