Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer

Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.先前接受治疗的患者为8个月
 

AstraZeneca and Daiichi Sankyo’s (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

欧盟委员会的批准是在 positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the DESTINY-Lung02 Phase II trial presented at the IASLC 2023 World Conference on Lung Cancer and simultaneously published in the 临床肿瘤学杂志. 

In the trial, Enhertu 5.4mg/kg 证实客观缓解率(ORR)为49.95%可信区间[CI] 39.0-59.1), 盲法独立中心评价(BICR), in patients with previously treated advanced or metastatic HER2-mutant (HER2m) NSCLC. One (1.0%的患者完全缓解(CR)， 49%的患者完全缓解(CR).0%)观察到部分反应(PR). 中位反应持续时间(DoR)为16.8 months (95% CI 6.4-未估计[东北].

Martin Reck, MD, PhD, 胸肿瘤科的主任, 格罗斯海斯多夫肺科诊所, Germany, said: “HER2-mutant non-small cell lung cancer is more commonly diagnosed in patients who are younger and female, and there are limited treatment options which often results in a poor prognosis. Enhertu is the first HER2-directed therapy to demonstrate strong and durable results for these patients, and this EU approval marks an important step forward in how the disease can be treated.”

Dave Fredrickson, 执行副总裁, 肿瘤事业部, AstraZeneca, said: “Understanding the molecular drivers behind a lung cancer diagnosis is critical, 虽然现在很多病人都有针对性的选择, those with HER2-mutant non-small cell lung cancer have had few treatment options, none of which have been approved to treat their specific type of lung cancer. Enhertu is the first HER2-directed option approved for HER2-mutant disease and confirms the relevance of HER2 as a target in lung cancer.”

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc.他说:“自从澳门葡京赌博游戏最初批准 Enhertu 两年多前在欧盟进行转移性乳腺癌的研究, we have remained committed to bringing this innovative antibody drug conjugate to more patients with HER2-targetable tumours, especially those that have previously not been eligible for treatment with a HER2-directed therapy. 今天的新闻， Enhertu is the first antibody drug conjugate approved for lung cancer in the EU and is now approved in three different tumour types.”

的安全概况 Enhertu in the DESTINY-Lung02 trial was consistent with previous clinical trials with no new safety signals identified.

金融方面的考虑
欧盟批准后, an amount of $75m is due from AstraZeneca to Daiichi Sankyo as a milestone payment for this HER2-mutant (HER2m) NSCLC indication. The milestone payment will be capitalised as an addition to the upfront payment made by AstraZeneca to Daiichi Sankyo in 2019 and subsequent capitalised milestones.

Sales of Enhertu 在大多数欧盟领土上都是Daiichi Sankyo认可的. 澳门葡京网赌游戏报告其毛利率份额来自 Enhertu sales in those territories as alliance revenue in the Company’s financial statements. AstraZeneca will record product sales in respect of sales made in territories where AstraZeneca is the selling party.

有关财务安排的进一步详情载于 2019年3月公告 关于合作.

Notes

HER2m NSCLC
Lung cancer is the second most common form of cancer globally with more than two million cases diagnosed in 2020.¹ In Europe, lung cancer is the third most commonly diagnosed cancer with more than 477,到2020年确诊的病例将达到1000例.² Lung cancer is also the leading cause of cancer-related deaths in Europe, with nearly 400,2020年报告的死亡人数为1000人.² Prognosis is particularly poor for patients with metastatic NSCLC as only approximately 9% will live beyond five years after diagnosis.³

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of multiple tumour types. Certain HER2 (ERBB2) gene alterations (called HER2 mutations) have been identified in patients with non-squamous NSCLC as a distinct molecular target, and occur in approximately 2-4% of patients with this type of lung cancer.^4,5 而HER2基因突变可发生在一系列患者中, 它们更常见于年轻的非小细胞肺癌患者, 女性，从未吸烟.⁶ HER2 gene mutations have been independently associated with cancer cell growth and poor prognosis, 随着脑转移的发病率增加.⁷ Next-generation sequencing has been utilised in the identification of HER2 (ERBB2) mutations.^8,9

DESTINY-Lung02
DESTINY-Lung02 is a global, randomised Phase II trial evaluating the safety and efficacy of Enhertu in patients with HER2m advanced or metastatic NSCLC with disease recurrence or progression during or after at least one regimen of prior anticancer therapy that must have contained a platinum-based chemotherapy. 患者按2:1随机分组接受治疗 Enhertu 5.4mg/kg (n=102) or Enhertu 6.4mg/kg (n=50).

试验的主要终点是由BICR评估的确认ORR. 次要端点包括DoR, 确诊疾病控制率, 研究者和BICR评估无进展生存期, 整体生存与安全. 

DESTINY-Lung02 enrolled 152 patients at multiple sites, including Asia, Europe and North America. 有关该试验的更多信息，请访问 ClinicalTrials.gov. 

Enhertu
Enhertu 是her2导向ADC吗. 采用Daiichi Sankyo专有的DXd ADC技术设计， Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads, (一个exatecan衍生物, DXd), 通过基于四肽的可切割连接体.

Enhertu (5.4mg/kg) is approved in more than 55 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a (or one or more) prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 40 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. 

Enhertu (5.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have activating HER2 (ERBB2) mutations, 由当地或地区认可的测试检测到的, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 and/or DESTINY-Gastric02 trials.

Enhertu 发展计划
一项全面的临床开发计划正在全球范围内进行, 评价的有效性和安全性 Enhertu 单药治疗多种her2靶向癌症. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.   

第一三共合作
第一三共公司, Limited (TSE: 4568) [referred to as Daiichi Sankyo] and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (her2定向ADC) March 2019和datopotamab deruxtecan(一种trop2定向ADC) July 2020在日本，Daiichi Sankyo拥有专有权. Daiichi Sankyo负责生产和供应 Enhertu 和datopotamab deruxtecan. 

澳门葡京网赌游戏治疗肺癌
AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most. 

The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Enhertu 与Daiichi Sankyo合作的datopotamab deruxtecan; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action.

澳门葡京网赌游戏是Lung Ambition Alliance的创始成员之一, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, 包括治疗之外的.

澳门葡京网赌游戏在肿瘤学
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, 开发并向患者提供改变生活的药物.

该公司专注于一些最具挑战性的癌症. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

澳门葡京网赌游戏的愿景是重新定义癌症治疗和, one day, 消除癌症作为死亡原因.

AstraZeneca
澳门葡京网赌游戏(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门葡京赌博游戏公司，专注于发现, development, 以及肿瘤学处方药的商业化, Rare Diseases, 和澳门葡京赌博游戏, 包括心血管, Renal & 新陈代谢和呼吸 & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit tincyn.net 并在社交媒体上关注公司 @AstraZeneca.

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References