2020年5月11日07:00
接受Lynparza和bevacizumab治疗的患者37年没有疾病进展.2 months vs. 17.单抗贝伐单抗的中位治疗时间为7个月
每两个患有晚期卵巢癌的女性中就有一个患有hrd阳性肿瘤
澳门在线赌城娱乐和默沙东公司.肯尼沃斯，n.n.J.美国默克公司(Merck) & Co., Inc. 在美国和加拿大境内)今天宣布 Lynparza (olaparib) in combination with bevacizumab has been approved in the US for the maintenance treatment of adult patients with advanced epithelial ovarian, 输卵管 or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, 和/或基因组不稳定性. 患者将根据fda批准的伴随诊断测试来选择治疗方案.
The approval by the US Food and Drug Administration (FDA) was based on a biomarker subgroup analysis of the III期PAOLA-1试验 这表明 Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67% (equal to a hazard ratio of 0.33). 的加入 Lynparza 将无进展生存期(PFS)提高至中位数37.2个月对17个月.hrd阳性晚期卵巢癌患者单独使用贝伐单抗7个月.
大约每两个患有晚期卵巢癌的女性中就有一个患有hrd阳性肿瘤. 用于晚期卵巢癌患者, the primary aim of 1st-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission.
伊莎贝尔Ray-Coquard, PAOLA-1试验的首席研究员和医学肿瘤学家, 中心lsamon bsamrard和GINECO集团主席, 她说:“卵巢癌是一种毁灭性的疾病. 在PAOLA-1试验中，hrd阳性患者的获益幅度是有影响的. 的结合 Lynparza and bevacizumab now provides women with HRD-positive advanced ovarian cancer with a new standard of care and I look forward to seeing this translate into clinical practice.”
戴夫Fredrickson, 执行副总裁, 肿瘤事业部, 他说:“这一批准代表着澳门第一赌城在线娱乐的又一个里程碑 Lynparza 在卵巢癌患者中. The median progression-free survival of more than three years offers new hope for more women to delay relapse in this difficult-to-treat disease. 这些结果进一步证实，hrd阳性是卵巢癌的一个独特亚群, and HRD testing is now a critical component for the diagnosis and tailoring of treatment for women with advanced ovarian cancer.”
Roy Baynes, 高级副总裁兼全球临床开发主管, 首席医疗官, MSD研究实验室, said: “Advances in understanding the role of biomarkers and PARP inhibition have fundamentally changed how physicians treat this aggressive type of cancer. Today’s approval based on the PAOLA-1 trial highlights the importance of HRD testing at diagnosis to identify those who may benefit from Lynparza 与贝伐单抗联合作为一线维持治疗.”
III期PAOLA-1试验的全部结果发表于 新英格兰医学杂志.
监管审查目前正在欧盟、日本和其他国家进行 Lynparza 基于PAOLA-1试验的结果. 作为广泛发展计划的一部分， Lynparza is being tested as a monotherapy and in combination across multiple tumour types including as a potential adjuvant treatment of patients with germline BRCA-mutated high-risk her2阴性 primary breast cancer in the Phase III OlympiA trial.
金融方面的考虑
在获得批准后 Lynparza in the US, 澳门在线赌城娱乐将从默沙东获得1亿美元的合作收入, 预计将在2020年第二季度由公司预订.
卵巢癌
卵巢癌是全球女性癌症死亡的第八大常见原因.1 2018年，新增确诊病例近30万例，死亡病例约18.5万例.2 Most women are diagnosed with advanced (Stage III or IV) ovarian cancer and have a five-year survival rate of approximately 30%.3 大约50%的卵巢癌是hrd阳性，包括BRCA1/2突变. 4,5 大约22%的卵巢癌有BRCA1/2突变.5
用于晚期卵巢癌患者, the primary aim of 1st-line treatment is to delay progression of the disease for as long as possible and maintain the patient’s quality of life with the intent of achieving complete remission.6,7,8,9
In the US, bevacizumab was approved for use in combination with chemotherapy for the 1st-line treatment of advanced ovarian cancer in 2018. Within two years nearly half of all patients with advanced ovarian cancer are receiving this combination treatment.10
PAOLA-1
PAOLA-1是一项双盲III期临床试验，旨在测试抗肿瘤药物的有效性和安全性 Lynparza 联合贝伐单抗vs. 贝伐单抗仅, as a 1st-line maintenance treatment for newly diagnosed advanced FIGO Stage III-IV high-grade serous or endometroid ovarian, 输卵管, or peritoneal cancer patients who had a complete or partial response to 1st-line treatment with platinum-based chemotherapy and bevacizumab. 澳门在线赌城娱乐和默沙东 2019年8月宣布 该试验达到了PFS的主要终点.
同时, Myriad Genetics myChoice CDx测试已经在美国被批准作为一种伴随诊断 Lynparza 在这个新的指示中.
同源重组缺陷
HRD, 卵巢癌亚组的定义是什么, 包括广泛的基因异常, 包括BRCA突变等. 就像BRCA基因突变一样, HRD interferes with normal cell DNA repair mechanisms and confers sensitivity to PARP inhibitors including Lynparza.5
Lynparza
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair, 比如BRCA1和/或BRCA2的突变. 对PARP的抑制作用 Lynparza 导致捕获与DNA单链断裂结合的PARP, 复制分叉停止, 它们的崩溃，DNA双链断裂和癌细胞死亡. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.
Lynparza 目前是否在一些国家获得批准, 包括欧盟国家, 用于铂敏感复发卵巢癌的维持治疗. 它已在美国获得批准, the EU, Japan, China, and several other countries as 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. 它在美国也获得了批准, Japan, 以及其他一些国家的brca基因突变, her2阴性, 转移性乳腺癌, previously treated with chemotherapy; in the EU, 这包括局部晚期乳腺癌. Lynparza is approved in the US and several other countries for the treatment of germline BRCA-mutated metastatic pancreatic cancer. 几个司法管辖区正在对卵巢进行监管审查, breast, 胰腺癌和前列腺癌.
Lynparza, 由澳门在线赌城娱乐和默沙东联合开发并商业化的药物, 已经被用来治疗30岁以上了吗,全球有5000名患者. Lynparza 是否拥有所有PARP抑制剂中最广泛和最先进的临床试验开发计划, and 澳门在线赌城娱乐和默沙东 are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells
澳门在线赌城娱乐和默沙东战略肿瘤学合作
2017年7月，澳门在线赌城娱乐和默克 & Co., Inc.肯尼沃斯，n.nJ, US, 在美国和加拿大以外被称为MSD, 宣布全球肿瘤学战略合作，共同开发和共同商业化 Lynparza，世界上第一个PARP抑制剂，以及 Koselugo (selumetinib), 一种MEK抑制剂，对多种癌症有效. 携手合作，公司将会发展 Lynparza and Koselugo 与其他潜在的新药联合使用或作为单一疗法. 这些公司将独立发展 Lynparza and Koselugo 联合各自的PD-L1和PD-1药物.
澳门在线赌城娱乐在肿瘤学
澳门在线赌城娱乐在肿瘤学领域有着深厚的传统，并提供快速增长的药物组合 有可能改变患者生活和公司未来的新药. 2014年至2020年期间有6种新药上市，并且有广泛的研发渠道 开发中的小分子和生物制剂, 公司致力于将肿瘤作为澳门在线赌城娱乐专注于肺部的关键增长动力, ovarian, 乳腺癌和血癌. 除了澳门在线赌城娱乐的主要能力, the Company is actively pursuing innovative partnerships and investment that accelerate the delivery of our strategy, 正如在血液学领域对Acerta制药的投资所说明的那样.
通过利用四个科学平台的力量——免疫肿瘤学, 肿瘤驱动因素和耐药性, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, 澳门在线赌城娱乐的愿景是重新定义癌症治疗, one day, 消除癌症作为死亡原因.
AstraZeneca
澳门在线赌城娱乐(LSE/STO/NYSE: AZN)是一家全球性制药公司, 以科学为主导的澳门第一赌城在线娱乐公司，专注于发现, 处方药的开发和商业化, 主要用于治疗肿瘤等三个治疗领域的疾病, 心血管，肾脏和代谢, 呼吸和免疫学. 总部设在剑桥, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit sh-fyz.com 并在Twitter上关注公司 @AstraZeneca.
Contacts
References
1. Cancer.org. (2020). 卵巢癌统计|卵巢癌有多普遍. 可以在: www.cancer.org/cancer/ovarian-cancer/about/key-statistics.html. [2020年3月生效].
2. 世界卫生组织. IARC. Globocan 2018. 可以在: http://gco.iarc.fr/ [2020年3月生效].
3. 国家癌症研究所. (2019). 癌症统计资料:卵巢癌可在: http://seer.cancer.gov/statfacts/html/ovary.html [2020年3月生效].
4. Moschetta等人. (2016). 浆液性卵巢癌的BRCA体细胞突变和表观遗传修饰. 肿瘤学年鉴, 27(8), pp.1449-1455.
5. da Cunha Colombo Bonadio等. (2018). 卵巢癌同源重组缺乏症的流行病学及治疗进展. 诊所(圣保罗). 16 2018; 73 (5): e450s.
6. Moore, K. (2018). 奥拉帕尼在新诊断晚期卵巢癌患者中的维持作用. 新英格兰医学杂志, 379(26), pp.2495-2505.
7. Raja et al. 2012. 卵巢癌的最佳一线治疗. 肿瘤学年鉴. 23增刊10,x118-127.
8. NHS选择，卵巢癌可在:
http://www.nhs./英国/条件/Ovarian cancer/治疗 [2020年3月生效].
9. Ledermann等. (2013). 新诊断和复发的上皮性卵巢癌:ESMO临床实践诊断指南, 治疗及随访. 肿瘤学年鉴, 24, pp.vi24-vi32.
10. 澳门在线赌城娱乐数据存档. Kantar Health, 2020年第一季度.
Adrian Kemp
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澳门在线赌城娱乐