Tagrisso with the addition of chemotherapy approved in the EU as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer

Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. 注意标准
 

澳门葡京网赌游戏公司 Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in the European Union (EU) for the 1st-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.

欧盟委员会的批准是在 积极的观点 人用医药产品委员会的报告，并基于 FLAURA2 III期试验发表于 新英格兰医学杂志.

在审判中， Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death by 38% by investigator assessment compared to Tagrisso 单一疗法是全球一线治疗标准(风险比[HR] 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001). 中位无进展生存期(PFS)为25.治疗5个月 Tagrisso 加上化疗，得8分.8个月改善对比 Tagrisso 单一疗法(16.7 months).

PFS results from blinded independent central review (BICR) were consistent with the results by investigator assessment, showing 29.中位PFS为4个月 Tagrisso 加上化疗，得了9分.5个月改善 Tagrisso 单一疗法(19.9个月)(HR 0.62; 95% CI 0.48-0.80; nominal p=0.0002).

Results from a prespecified exploratory analysis of patients in the FLAURA2 trial with brain metastases at baseline showed Tagrisso plus chemotherapy reduced the risk of central nervous system (CNS) disease progression or death by 42% compared to Tagrisso 单药治疗(HR 0.58; 95% CI 0.33-1.01)根据BICR评估. 经过两年的随访，74%的患者接受了 Tagrisso plus chemotherapy had not experienced CNS disease progression or death versus 54% of patients treated with Tagrisso 单药治疗.

而在第二次中期分析中，总生存期(OS)结果仍然不成熟(成熟度为41%)。, 观察到操作系统获益的趋势 Tagrisso 加上化疗 Tagrisso 单独(HR 0).75; 95% CI 0.57-0.97), as presented 在2024年欧洲肺癌大会上. 该试验继续评估OS作为一个关键的次要终点.   

大卫Planchard, MD, PhD, Gustave Roussy肿瘤研究所的胸部肿瘤学家，也是该试验的主要研究者, 他说:“今天的消息标志着欧洲egfr突变肺癌患者的重大进展, 提供了一个新的一线治疗选择与奥西替尼现在联合化疗. FLAURA2的结果建立在奥西替尼单药治疗的既定疗效之上, showing a meaningful nine-month improvement in progression-free survival and offering physicians the option to tailor treatment to a patient’s specific needs.”

戴夫Fredrickson, 执行副总裁, 肿瘤事业部, 澳门葡京网赌游戏, 他说:“这一批准强化了 Tagrisso as the backbone therapy in EGFR-mutated lung cancer either as 单药治疗 or in combination with chemotherapy. 这对那些具有更强侵袭性疾病的人尤其重要, 包括癌症已经扩散到大脑的患者和L858R突变的患者.”

的安全概况 Tagrisso 此外，化疗与单个药物的既定概况一致. 不良事件(AE)发生率较高 Tagrisso 加上化疗组，由特征明确的化疗相关ae驱动. 停药率 Tagrisso ae的比例为11% Tagrisso 加上化疗和6%的单一疗法.   

Tagrisso 在包括美国、欧盟、中国和日本在内的110多个国家被批准为单一疗法. Approved indications include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, 局部晚期或转移性EGFR T790M突变阳性的NSCLC, 以及早期EGFRm的辅助治疗. Tagrisso 加上化疗也在美国获得批准, China, Japan and several other countries for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC. Tagrisso 目前是否正在接受全球监管机构对不可切除患者的审查, 基于LAURA III期试验的NSCLC III期EGFRm.     

Notes
肺癌
肺癌是男性和女性癌症死亡的主要原因, 占所有癌症死亡人数的五分之一.5 肺癌大致分为非小细胞肺癌和小细胞肺癌.3 每年估计有2个.全球有400万人被诊断患有肺癌, 80-85%的患者被诊断为NSCLC, 最常见的肺癌.3,5-6

在欧洲，每年有超过45万人被诊断患有肺癌.1 在美国和欧洲大约有10-15%的NSCLC患者, 亚洲30-40%的患者有EGFRm.7-9 此外，大多数NSCLC患者被诊断为晚期疾病.4 Patients with EGFRm NSCLC are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor (EGFR-TKI) which blocks the cell-signalling pathways that drive the growth of tumour cells.10

FLAURA2
FLAURA2是随机的, open-label, 的多中心, global Phase III trial in the 1st-line treatment of patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC. 患者接受了 Tagrisso 80mg once-daily oral tablets with the addition of chemotherapy (pemetrexed (500mg/m2) plus cisplatin (75mg/m2) or carboplatin (AUC5)) every three weeks for four cycles, 紧随其后的是 Tagrisso 每三周使用培美曲塞进行维护.

该试验在20多个国家的150多个中心招募了557名患者, 包括在美国, Europe, 南美洲和亚洲. 主要终点为PFS. 该试验正在进行中，并将继续评估OS的次要终点.

Tagrisso
Tagrisso (osimertinib)是第三代, 在非小细胞肺癌中具有临床活性的不可逆EGFR-TKI, 包括对抗中枢神经系统转移. Tagrisso (40毫克和80毫克，每日一次口服片剂)已用于治疗近800人,澳门葡京网赌游戏将继续探索其在全球的适应症 Tagrisso 作为跨阶段EGFRm NSCLC患者的一种治疗方法.

有大量的证据支持使用 Tagrisso 在非小细胞肺癌EGFRm中. Tagrisso 唯一的靶向治疗是改善早期疾病患者的预后吗 ADAURA III期试验，局部的晚期阶段 LAURA III期试验 和晚期疾病 FLAURA III期试验 and FLAURA2 III期试验. 

作为澳门葡京网赌游戏持续致力于尽早治疗肺癌患者的一部分, Tagrisso is also being investigated in the neoadjuvant setting in the NeoADAURA III期试验 with results expected later this year and in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

The Company is also researching ways to address tumour mechanisms of resistance through the SAVANNAH and ORCHARD Phase II trials, 以及SAFFRON III期试验, which test Tagrisso 加上savolitinib, an oral, 有效和高选择性的MET TKI, 以及其他潜在的新药.

澳门葡京网赌游戏治疗肺癌
澳门葡京网赌游戏 is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, 同时也在推动科学的发展，以改善耐药和高级环境的结果. 通过定义新的治疗靶点和研究创新方法, 公司的目标是将药物匹配到最能受益的患者.

The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso and Iressa (吉非替尼); Imfinzi (durvalumab)和 Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan)和datopotamab deruxtecan与Daiichi Sankyo合作; 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
澳门葡京网赌游戏 is leading a revolution in oncology with the ambition to provide cures for cancer in every form, 跟随科学去了解癌症及其所有的复杂性, 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 澳门葡京网赌游戏 has built one of the most diverse portfolios and pipelines in the industry, 有可能催化医学实践的变化，改变病人的体验.

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.

澳门葡京网赌游戏
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, 发展, 以及肿瘤学处方药的商业化, 罕见疾病, 和澳门葡京赌博游戏, 包括心血管, Renal & 新陈代谢和呼吸 & Immunology. 总部设在剑桥, UK, 澳门葡京网赌游戏's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. 请访问 澳门葡京网赌游戏.com 并在社交媒体上关注公司 @澳门葡京网赌游戏.

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References

  1. Ferlay J，等. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. 欧洲癌症. 2018;103:356-387.
  2. Sanden SV，等. Prevalence of Epidermal Growth Factor Receptor Exon 20 Insertion Mutations in Non-small-Cell Lung Cancer in Europe: A Pragmatic Literature Review and Meta-analysis. 针对Onc. 2022;17:153-166.
  3. LUNGevity基金会. 肺癌的种类. 可在:http://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. 2024年7月发布.
  4. González M，等. 来自一个机构的早期和局部晚期非小细胞肺癌的总生存期:2000-2017. 23 .临床翻译. 2021;1325–1333
  5. 世界卫生组织. 国际癌症研究机构. 肺部情况说明. 可在:http://gco.iarc.who.int /媒体/ globocan /新闻/癌症/ 15-trachea-bronchus-and-lung-fact-sheet.pdf. 2024年7月发布.   
  6. Cheema PK等. III期局部晚期不可切除非小细胞肺癌的治疗进展展望. Curr Oncol. 2019;26(1):37-42
  7. Keedy VL，等. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J .临床肿瘤学. 2011;29:2121-27.
  8. Szumera-Ciećkiewicz A，等. 非小细胞肺癌细胞学和组织学样本的EGFR突变检测:一个改进, 欧洲发病率的单机构研究和系统评价. 临床经验病理学. 2013;6:2800-2812. 
  9. 埃里森G，等人. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. 临床病理学. 2013;66:79-89.
  10. 交叉DA等. AZD9291, 一个不可逆的EGFR TKI, 克服t790m介导的肺癌对EGFR抑制剂的耐药. 癌症越是加大. 2014;4(9):1046-1061.

tags

  • Oncology
  • 公司和金融