Combination shows consistent benefit across prespecified post-progression outcomes
Results from the FLAURA2 III期试验 showed 澳门葡京网赌游戏’s Tagrisso (osimertinib) with the addition of chemotherapy provided a clinically meaningful 和 consistent benefit in subsequent outcomes after disease progression in patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Tagrisso with the addition of chemotherapy also demonstrated a favourable trend toward overall survival (OS) improvement at two years of follow up. These results were presented today at the 2024 欧洲an Lung Cancer Congress (ELCC) in Prague, 捷克共和国(摘要# 40).
在此之前 主要终点数据 presented at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) 和 published in 新英格兰医学杂志, 显示 Tagrisso with the addition of chemotherapy demonstrated a statistically significant 和 clinically meaningful improvement in progression-free survival (PFS). 2024年2月， Tagrisso 加上化疗是 在美国获得批准 后 优先审核 by the Food 和 Drug Administration (FDA) based on these results.
At 41% data maturity, the OS interim results showed a favourable trend with the Tagrisso 加化疗组(风险比[HR] 0.75; 95% confidence interval [CI] 0.57-0.97), with consistent results across prespecified subgroups, 包括性, 比赛, EGFR突变类型, 诊断时的年龄, 吸烟史, performance status 和 central nervous system (CNS) metastases status at baseline. The OS data were not statistically significant at this interim analysis 和 will continue to be assessed as a key secondary endpoint at final analysis.
Tagrisso with the addition of chemotherapy also showed a consistent benefit across prespecified post-progression endpoints of time to first subsequent treatment (TFST; HR 0.73; 95% CI 0.56-0.94), time to progression on 2nd-line therapy (PFS2; HR 0.70; 95% CI 0.52-0.93) 和 time to second subsequent treatment (TSST; HR 0.69; 95% CI 0.51-0.93).
帕斯一. 珍妮, MD, 博士学位, medical oncologist at Dana-Farber Cancer Institute 和 principal investigator for the trial, said: “The improvement in post-progression outcomes with chemotherapy added to st和ard-of-care osimertinib is encouraging for patients with advanced EGFR-mutated lung cancer, particularly the encouraging trend toward overall survival. These results further validate the importance of this additional treatment option, especially for those patients whose cancer has spread to the brain, 携带L858R突变的人, 或者其他导致预后不良的原因.”
Susan Galbraith, Executive Vice President, 肿瘤学 R&澳门葡京网赌游戏的博士说:“FLAURA2加强了 Tagrisso as the backbone therapy in EGFRm non-small cell lung cancer either as 单药治疗 or in combination with chemotherapy, delivering the longest reported progression-free survival benefit in the 1st-line advanced setting. We’re excited to see a favourable trend toward overall survival 和 look forward to seeing this data mature over time.”
Summary of key post-progression results: FLAURA2
|
Tagrisso 加化疗 (n=279) |
Tagrisso 单药治疗 (n=278) |
|---|---|---|
TFSTi |
||
中位TFST，以月为单位(95% CI) |
30.7 (27.3, NCii) |
25.4 (22.8, NCii) |
风险比(95% CI) |
0.73 (0.56-0.94) |
|
PFS2i |
||
中位PFS2，以月为单位(95% CI) |
30.6 (29.0-NCii) |
27.8 (26.0-NCii) |
风险比(95% CI) |
0.70 (0.52-0.93) |
|
TSSTi |
||
中位TSST，以月为单位(95% CI) |
NR3 (NCii-NCii) |
33.2 (28.2-NCii) |
风险比(95% CI) |
0.69 (0.51-0.93) |
|
第二个临时操作系统i |
||
中位OS，以月为单位(95% CI) |
NR3 (38.0-NCii) |
36.7 (33.2-NCii) |
风险比(95% CI) |
0.75 (0.57-0.97) |
|
| i The data cut-off date was 3 April 2023 *except second interim OS, which was 8 January 2024 ii NC:不可计算 3 NR:未达到 |
||
Additional safety analyses from the FLAURA2 trial were also presented at ELCC (abstract #10P). Results showed adverse event onset frequency 和 severity were highest following initial chemotherapy added to Tagrisso 和 reduced over time during the maintenance period.
An analysis of patient-reported outcomes from the FLAURA2 trial was also presented at ELCC (abstract #9P). Results showed a trend toward improved health-related quality of life (HRQoL) 和 a trend toward improvement in several symptoms following chemotherapy added to Tagrisso. Symptoms included dyspnoea (shortness of breath or breathlessness), chest pain 和 cough. Any decline in HRQoL from adding chemotherapy to Tagrisso was not clinically meaningful 和 was temporary, resolving after chemotherapy was completed.
Tagrisso is also approved as 单药治疗 in more than 100 countries 包括在美国, EU, China 和 Japan. Approved indications include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, 和 adjuvant treatment of early-stage EGFRm NSCLC. Regulatory applications are under review in several countries based on the FLAURA2 Phase III results.
As part of 澳门葡京网赌游戏’s ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso is also being investigated in the neoadjuvant setting in the NeoADAURA III期试验 with results expected later this year, 和 in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial. Each of these Phase III trials serves to reinforce the proven benefit of Tagrisso 在早期的场景中.
笔记
肺癌
肺癌 is the leading cause of cancer death among both men 和 women, accounting for about one-fifth of all cancer deaths.1 肺癌 is broadly split into NSCLC 和 small-cell lung cancer.2 每年估计有2个.4 million people diagnosed with lung cancer globally, with 80-85% of patients diagnosed with NSCLC, 最常见的肺癌. The majority of all NSCLC patients are diagnosed with advanced disease.1-3
Approximately 10-15% of NSCLC patients in the US 和 欧洲, 和 30-40% of patients in Asia have EGFRm NSCLC.4-6 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.7
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 with pemetrexed maintenance every three weeks.
The trial enrolled 557 patients in more than 150 centres across more than 20 countries, 包括在美国, 欧洲, 南美洲和亚洲. 主要终点为PFS. The trial is ongoing 和 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, 包括对抗中枢神经系统转移. Tagrisso (40mg 和 80mg once-daily oral tablets) has been used to treat more than 800,000 patients across its indications worldwide 和 澳门葡京网赌游戏 continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.
T在这里 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 both 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 和 FLAURA2 III期试验.
The Company is also researching ways to address tumour mechanisms of resistance through the SAVANNAH 和 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 和 treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant 和 advanced settings. By defining new therapeutic targets 和 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 和 the next wave of innovations, 包括 Tagrisso 和 艾瑞莎 (吉非替尼); Imfinzi (durvalumab)和 Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) 和 datopotamab deruxtecan in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines 和 combinations across diverse mechanisms of action.
澳门葡京网赌游戏 is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation 和 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, following the science to underst和 cancer 和 all its complexities to discover, develop 和 deliver life-changing medicines to patients.
The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that 澳门葡京网赌游戏 has built one of the most diverse portfolios 和 pipelines in the industry, with the potential to catalyse changes in the practice of medicine 和 transform the patient experience.
澳门葡京网赌游戏 has the vision to redefine cancer care 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) is a global, science-led biopharmaceutical company that focuses on the discovery, 发展, 和 commercialisation of prescription medicines in 肿瘤学, 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 operates in over 100 countries 和 its innovative medicines are 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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