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

基于FLAURA2结果的批准，Tagrisso加化疗延长 中位无进展生存期缩短了近9个月. 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 Japan for the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.   

The approval by the Japanese Pharmaceuticals and Medical Device Agency (PMDA) was based on the results from the FLAURA2 III期试验，也发表于 新英格兰医学杂志.

结果显示 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个月).

PFS results by blinded independent central review  were consistent with results by investigator assessment, 显示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; p=0.0002). 

而在第二次中期分析中，总生存期(OS)仍然不成熟(41%成熟)。, 观察到一个令人鼓舞的趋势，即操作系统的好处 Tagrisso 加上化疗 Tagrisso 单独(HR 0).75; 95% CI 0.57-0.97)，在捷克共和国布拉格举行的2024年欧洲肺癌大会(ELCC)上发表(摘要# 4 o). 该试验继续评估OS作为一个关键的次要终点. 

肺癌是全球和日本癌症相关死亡的最常见原因.^1-2 肺癌是日本第二常见的癌症类型，超过135例,每年诊断出的病人有000人.² 在NSCLC患者中, 最常见的肺癌, 大约36%的日本患者患有EGFR突变的肿瘤.³ 此外，大多数NSCLC患者被诊断为晚期疾病.⁴

彦小林, MD, 博士学位, Professor at Saitama Medical University International Medical Center and a principal investigator in the trial, said: “The FLAURA2 results showed osimertinib with the addition of chemotherapy provided a nearly nine-month improvement in progression-free survival versus osimertinib monotherapy. 这一批准为这种侵袭性肺癌带来了一个重要的新治疗选择, 是日本癌症死亡的主要原因.”

戴夫Fredrickson, 执行副总裁, 肿瘤事业部, 澳门葡京网赌游戏, 他说:“今天在日本的认可得到了巩固 Tagrisso as the backbone therapy for patients with EGFR-mutated lung cancer either in combination with chemotherapy or as monotherapy, 现在提供两种有效的一线治疗方案. 结合的机会 Tagrisso 化疗对于那些预后较差的患者尤其重要, 比如那些疾病已经扩散到大脑的人，或者那些携带L858R突变的人.”

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100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 with the addition of chemotherapy is also approved in the US and several other countries for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.  

笔记

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一.¹ 肺癌大致分为非小细胞肺癌和小细胞肺癌.¹ 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.^4-6

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 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, 非盲, 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, 欧洲, 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, 包括中枢神经系统(CNS)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, 哪些测试 Tagrisso 加上savolitinib, 口服, 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, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. 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, 包括 Tagrisso and 艾瑞莎 (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, 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, 有一天,, 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, 肾 & 新陈代谢和呼吸 & 免疫学. 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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