Tagrisso联合化疗在日本被批准为egfr突变晚期肺癌患者的新一线治疗药物

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)加培美曲塞和铂基化疗已在日本被批准用于局部晚期或转移性表皮生长因子受体突变(EGFRm)非小细胞肺癌(NSCLC)成人患者的一线治疗，其肿瘤具有外显子19缺失或外显子21 (L858R)突变.   

日本药品和医疗器械管理局(PMDA)的批准是基于该研究的结果 FLAURA2 III期试验，也发表于 新英格兰医学杂志.

结果显示 Tagrisso 与研究者评估的相比，化疗使疾病进展或死亡的风险降低了38% Tagrisso monotherapy, which is the 1st-line global 注意标准 (hazard ratio [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).

盲法独立中心评价的PFS结果与研究者评估的结果一致, 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; p=0.0002). 

While the overall survival (OS) remained immature at the second interim analysis (41% maturity), an encouraging trend towards an OS benefit was observed with Tagrisso 加上化疗 Tagrisso alone (HR 0.75; 95% CI 0.57-0.97), presented at the 2024 European Lung Cancer Congress (ELCC) in Prague, Czech Republic (摘要# 4 o). The trial continues to assess OS as a key secondary endpoint. 

肺癌 is the most common cause of cancer-related deaths both globally and in Japan.^1-2 肺癌 is the second most prevalent cancer type in Japan with more than 135,每年诊断出的病人有000人.² 在NSCLC患者中, 最常见的肺癌, approximately 36% of patients in Japan have tumours with an EGFR mutation.³ Additionally, the majority of patients with NSCLC are diagnosed with advanced disease.⁴

彦小林, MD, PhD, 埼玉医科大学国际医学中心教授，也是该试验的主要研究者, 他说:“FLAURA2结果显示，与奥西替尼单药治疗相比，奥西替尼加化疗可使无进展生存期提高近9个月. This approval brings an important new treatment option for this aggressive form of lung cancer, 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 作为egfr突变肺癌患者的主要治疗方法，无论是联合化疗还是单独治疗, now providing two effective first-line treatment options. 结合的机会 Tagrisso with chemotherapy is especially important for those patients with a poorer prognosis, such as those whose disease has spread to the brain or those with L858R mutations.”

的安全概况 Tagrisso plus chemotherapy was consistent with the established profiles of the individual medicines. 不良事件(AE)发生率较高 Tagrisso plus chemotherapy arm, driven by well-characterised chemotherapy-related AEs. 停药率 Tagrisso ae的比例为11% Tagrisso 加上化疗和6%的单一疗法.

Tagrisso is approved as monotherapy in more than 100 countries 包括在美国, EU, China and Japan. 批准的适应症包括局部晚期或转移性EGFRm NSCLC患者的一线治疗, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, 以及早期EGFRm的辅助治疗. Tagrisso 在美国和其他几个国家也被批准用于局部晚期或转移性EGFRm NSCLC患者的一线治疗.  

Notes

肺癌
肺癌 is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.¹ 肺癌 is broadly split into NSCLC and small cell lung cancer.¹ 每年估计有2个.4 million people diagnosed with lung cancer globally, 80-85%的患者被诊断为NSCLC, 最常见的肺癌.^4-6

Approximately 10-15% of NSCLC patients in the US and Europe, 亚洲30-40%的患者有EGFRm.^7-9 EGFRm NSCLC患者对egfr -酪氨酸激酶抑制剂(EGFR-TKI)治疗特别敏感，EGFR-TKI阻断了驱动肿瘤细胞生长的细胞信号通路.¹⁰

FLAURA2
FLAURA2是随机的, open-label, 的多中心, 全球III期临床试验，用于一线治疗局部晚期(IIIB-IIIC期)或转移性(IV期)EGFRm NSCLC患者. 患者接受了 Tagrisso 80mg口服片剂，每日1次，加化疗(培美曲塞(500mg/m2) +顺铂(75mg/m2)或卡铂(AUC5)，每3周，共4个周期, followed by Tagrisso 每三周使用培美曲塞进行维护.

The trial enrolled 557 patients in more than 150 centres across more than 20 countries, 包括在美国, Europe, 南美洲和亚洲. 主要终点为PFS. The trial is ongoing and will continue to assess the secondary endpoint of OS.

Tagrisso
Tagrisso (osimertinib)是第三代, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to treat nearly 800,000 patients across its indications worldwide and 澳门葡京网赌游戏 continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.

There is an extensive body of evidence supporting the use of Tagrisso 在非小细胞肺癌EGFRm中. Tagrisso is the only targeted therapy to improve patient outcomes in early-stage disease in the 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. 

As part of 澳门葡京网赌游戏公司 ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso 在新辅助的NeoADAURA III期试验中也正在进行研究，预计将于今年晚些时候获得结果，在ADAURA2 III期试验中也正在进行早期辅助可切除的研究.

该公司还在通过SAVANNAH和ORCHARD II期试验研究解决肿瘤耐药机制的方法, 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
澳门葡京网赌游戏正致力于通过早期疾病的检测和治疗，使肺癌患者更接近治愈, 同时也在推动科学的发展，以改善耐药和高级环境的结果. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most.

该公司的综合产品组合包括领先的肺癌药物和下一波创新, including Tagrisso and Iressa (吉非替尼); Imfinzi (durvalumab)和 Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and datopotamab deruxtecan in collaboration with Daiichi Sankyo; 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 is a founding member of the Lung Ambition Alliance, 一个致力于加速创新并为肺癌患者提供有意义改善的全球联盟, 包括治疗之外的.

澳门葡京网赌游戏在肿瘤学
澳门葡京网赌游戏正在引领肿瘤学领域的一场革命，致力于为各种形式的癌症提供治疗, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. 正是通过持续的创新，澳门葡京网赌游戏建立了行业中最多样化的产品组合和管道之一, 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 has the vision to redefine cancer care and, 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, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, 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, 澳门葡京网赌游戏的创新药物在超过125个国家销售，并被全球数百万患者使用. 请访问 jnjsp.com 并在社交媒体上关注公司 @澳门葡京网赌游戏.

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