阿斯利康宣布启动自家anti-PD-1新药MEDI4736的对NSCLC的三期临床

AstraZeneca initiates phase III immunotherapy study for MEDI4736 in patients with lung cancer
阿斯利康启动MEDI4756免疫治疗对肺癌患者的三期临床研究

First MedImmune oncology immunotherapy targeting the PD-L1/PD-1 pathway progresses into Phase III
MedImmune 的首个肿瘤免疫靶向PD-L1/PD1通路的药进到了三期临床

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.
AZ今天宣布开始4736的三期临床项目，4736是用于治疗NSCLC和其他肿瘤的在研免疫治疗药物。三期项目的第一个临床叫PACIFIC，其目标是评估MEDI4736对比安慰剂在局部晚期不可手术切除的NSCLC（III期）患者中的PFS和OS，这部分患者完成了前期的化疗并且没有肿瘤进展的表现（意思是前期化疗有效，将4736作维持治疗）。PACIFIC是免疫治疗在这部分患者群体中的第一个关键研究。

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.
4756是人用单克隆抗体，其直接对抗程序性细胞死亡配体PD-L1。来自PD-L1的信号能够帮助肿瘤逃避免疫系统的检查。4736能够通过阻断该信号来对抗肿瘤的免疫逃逸策略。4736用于加强患者的免疫系统来对抗肿瘤。

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."
全球药物研发部门的执行副总裁和首席医学官Briggs Morrison谈到：对于阿斯利康和MedImmune来说，这是个重要的里程碑。4736在我们的肿瘤免疫药物产品中是重要的组成部分，能够快速推进我们肿瘤免疫药物的pipeline。肺癌依然是首要的肿瘤杀手...(后面一堆官腔就不翻译了= =)

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.
在全球超过100个研究机构总共702位患者将被招募且随机分配进PACIFIC三期研究中。该三期研究是紧接于评估临床有效性和安全性的4736一期研究（就是说是从一期直接跳到三期的= =）。前期研究的最新信息将发表在今年的ASCO年会上。

（后面是肺癌和MedImmue的介绍，有空再翻译吧）
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.

http://www.astrazeneca.com/Media ... rapy-study-MEDI4736

老大真给力

http://clinicaltrials.gov/show/NCT02125461
这个是该临床的信息

在这个页面我们可以看到在Health Authorit里面列有CFDA（国家食品药品监督管理总局），所以这个药可能会在国内开临床，请大家关注一下这方面的信息，比较遗憾的是只针对三期的NSCLC

阿斯利康的药，感觉会靠谱～

辛苦了！非常感谢楼主带来了有用的信息

好消息，为什么不对4期的患者，这个群体的患者应该最多。

期待期待！貌似又一针对耐药的好药。

太好了，活着一天都有新的惊喜