2020年9月21日07:00英国夏令时
Patients treated with Lynparza 和 bevacizumab lived without disease progression for a median of 37.2个月vs. 17.单抗贝伐单抗治疗7个月
One in two women with advanced 卵巢 cancer has an HRD-positive tumour
澳门在线赌城娱乐和默沙东 Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced 卵巢 cancer.
The Committee for Medicinal Products for Human Use (CHMP) of the European 药物 Agency based its positive opinion on a biomarker subgroup analysis of the PAOLA-1 III期试验，出版于 新英格兰医学杂志.
试验表明 Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67% (based on a hazard ratio of 0.33; 95% confidence interval 0.25-0.45). 的加入 Lynparza improved progression-free survival (PFS) to a median of 37.2个月对17个月.7 months with bevacizumab alone in patients with HRD-positive advanced 卵巢 cancer.
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.1-3
卵巢癌 is the fifth most common cause of cancer death in Europe 和 the five-year survival rate is approximately 45%, due in part because women are often diagnosed with advanced disease (Stage III or IV).4,5
José Baselga, Executive Vice President, 肿瘤学 R&D, said: “Half of all newly diagnosed patients with advanced 卵巢 cancer have HRD-positive tumours. Lynparza together with bevacizumab has demonstrated a median progression-free survival benefit of more than three years, 为女性带来了新的希望. This recommendation is a vital step toward addressing a significant unmet need 和 could bring a new treatment option that delays relapse in this devastating disease.”
罗伊Baynes, Senior Vice President 和 Head of Global Clinical Development, 首席医疗官, MSD研究实验室, said: “HRD is an important biomarker of advanced 卵巢 cancer that can inform how physicians in 欧盟 treat this aggressive type of cancer. This recommendation 和 the results from the PAOLA-1 trial underscore the importance of HRD testing at diagnosis to determine the best course of treatment for women with advanced 卵巢 cancer.”
CHMP的建议是 Lynparza in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III 和 IV) high-grade epithelial 卵巢, 输卵管 or primary peritoneal cancer who are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy in combination with bevacizumab 和 whose cancer is associated with HRD positive status defined by either a 乳房 cancer susceptibility gene 1/2 (BRCA1/2) mutation 和/or genomic instability.
Further results from the PAOLA-1 trial recently presented during the 2020 European Society for Medical 肿瘤学 virtual congress showed that Lynparza in combination with bevacizumab maintenance treatment demonstrated a statistically significant improvement in the time to second disease progression (PFS2) versus bevacizumab alone in patients with HRD-positive advanced 卵巢 cancer, 一个关键的次要端点. 结果显示 Lynparza with bevacizumab provided benefit beyond first disease progression, improving PFS2 to a median of 50.3个月vs 35个月.单独使用贝伐单抗3个月.
Lynparza 联合贝伐单抗是 在美国获得批准 和 several other countries as a 1st-line maintenance treatment for patients with HRD-positive advanced 卵巢 cancer 和 is currently under regulatory review in other countries around the world.
卵巢癌
In 2018, 有将近68个,000 new cases of 卵巢 cancer diagnosed in Europe 和 around 45,000人死亡.4 Approximately 50% of 卵巢 cancers are HRD-positive including BRCA1/2 mutation.6,7 Approximately 22% of 卵巢 cancers have a BRCA1/2 mutation.6-8
同源重组缺陷
HRD, 卵巢癌亚组的定义是什么, encompasses a wide range of genetic abnormalities, 包括BRCA突变等. 就像BRCA基因突变一样, HRD interferes with normal cell DNA repair mechanisms 和 confers sensitivity to PARP inhibitors including Lynparza.9
PAOLA-1
PAOLA-1 is a double-blind Phase III trial testing the efficacy 和 safety of Lynparza added to st和ard-of-care bevacizumab versus bevacizumab alone, as a 1st-line maintenance treatment for newly diagnosed advanced FIGO Stage III-IV high-grade serous or endometroid 卵巢, 输卵管, or peritoneal cancer patients who had a complete or partial response to 1st-line treatment with platinum-based chemotherapy 和 bevacizumab. 澳门在线赌城娱乐和默沙东 2019年8月宣布 that the trial met its primary endpoint of PFS in the overall trial population.
Lynparza
Lynparza (olaparib) is a first-in-class PARP inhibitor 和 the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR), 比如BRCA1和/或BRCA2的突变. 对PARP的抑制作用 Lynparza leads to the trapping of PARP bound to DNA single-str和 breaks, 复制分叉停止, their collapse 和 the generation of DNA double-str和 breaks 和 cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects 和 dependencies in the DDR pathway.
Lynparza is currently approved in a number of countries, 包括欧盟国家, for the maintenance treatment of platinum-sensitive relapsed 卵巢 cancer. 它已在美国获得批准, 欧盟, 日本, 中国, 和 several other countries as 1st-line maintenance treatment of BRCA-mutated advanced 卵巢 cancer following response to platinum-based chemotherapy. It is also 在美国获得批准 as a 1st-line maintenance treatment with bevacizumab for patients with HRD-positive advanced 卵巢 cancer (BRCAm 和/or genomic instability). Lynparza 在美国被批准了吗, 日本, 和 a number of other countries for germline BRCA-mutated, her2阴性, 转移性乳腺癌, previously treated with chemotherapy; in 欧盟, this includes locally advanced 乳房 cancer. It is also 在美国获得批准 和 several other countries for the treatment of germline BRCAm metastatic pancreatic cancer. Lynparza 在美国被批准了吗 for HRR gene-mutated mCRPC (BRCAm 和 other HRR gene mutations). Regulatory reviews are underway in several countries for 卵巢, 乳房, 胰腺癌和前列腺癌.
Lynparza, which is being jointly developed 和 commercialised by 澳门在线赌城娱乐和默沙东, 已经被用来治疗30岁以上了吗,全球有5000名患者. Lynparza has the broadest 和 most advanced clinical trial development programme of any PARP inhibitor, 和 澳门在线赌城娱乐和默沙东 are working together to underst和 how it may affect multiple PARP-dependent tumours as a monotherapy 和 in combination across multiple cancer types. Lynparza is the foundation of 澳门在线赌城娱乐's industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.
The 澳门在线赌城娱乐和默沙东 strategic oncology collaboration
2017年7月，澳门在线赌城娱乐和默克 & Co.公司., 进军, NJ, US, 在美国和加拿大以外被称为MSD, announced a global strategic oncology collaboration to co-develop 和 co-commercialise Lynparza，世界上第一个PARP抑制剂，以及 Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza 和 Koselugo in combination with other potential new medicines 和 as monotherapies. 这些公司将独立发展 Lynparza 和 Koselugo in combination with their respective PD-L1 和 PD-1 medicines.
澳门在线赌城娱乐在肿瘤学
澳门在线赌城娱乐 has a deep-rooted heritage in oncology 和 offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives 和 the Company’s future. With seven new medicines launched between 2014 和 2020, 和 a broad pipeline of small molecules 和 biologics in development, the Company is committed to advance oncology as a key growth driver for 澳门在线赌城娱乐 focused on lung, 卵巢, 乳腺癌和血癌.
By harnessing the power of four scientific platforms – Immuno-肿瘤学, 肿瘤驱动因素和耐药性, DNA Damage Response 和 Antibody Drug Conjugates – 和 by championing the development of personalised combinations, 澳门在线赌城娱乐 has the vision to redefine cancer treatment 和, 有一天,, 消除癌症作为死亡原因.
澳门在线赌城娱乐
澳门在线赌城娱乐 (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development 和 commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - 肿瘤学, 心血管, 肾 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门在线赌城娱乐 operates in over 100 countries 和 its innovative medicines are used by millions of patients worldwide. 请访问 澳门在线赌城娱乐.com 并在推特上关注公司 @澳门在线赌城娱乐.
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参考文献
1. Raja等人. (2012). Optimal first-line treatment in 卵巢 cancer. 肿瘤学年鉴. 23增刊10,x118-127.
2. NHS选择，卵巢癌可在: http://www.nhs./英国/条件/Ovarian cancer/治疗 [2020年9月生效].
3. Ledermann等. (2013). Newly diagnosed 和 relapsed epithelial 卵巢 carcinoma: ESMO Clinical Practice Guidelines for diagnosis, 治疗及随访. 肿瘤学年鉴, 24, pp.vi24-vi32.
4. 世界卫生组织. 研究. Globocan. (2018). 可以在: http://gco.IARC.fr/ [2020年9月生效].
5. EuroHealth. (2018). 卵巢癌:沉默的杀手. 可以在: http://eurohealth.ie/policy-brief-women-and-ovarian-cancer-in-the-eu-2018/ [2020年9月生效].
6. Moschetta等人. (2016). BRCA somatic mutations 和 epigenetic BRCA modifications in serous 卵巢 cancer. 肿瘤学年鉴, 27(8), pp.1449-1455.
7. Bonadio等人. (2018). 同源重组缺陷 in 卵巢 cancer: a review of its epidemiology 和 management. 诊所， 73(增刊1):e450.
8. Pothuri. (2013). BRCA1- 和 BRCA2-related mutations: therapeutic implications in 卵巢 cancer. 肿瘤学年鉴, 24.
9. 摩尔,K. (2018). Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. 新英格兰医学杂志, 379(26), pp.2495-2505.
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