28 May 2020 22:00 BST
III期Adaura试验显示患者在手术后患有Tagrisso治疗，疗法意图降低了疾病复发或死亡的风险。80％
Detailed results from the Phase III ADAURA trial showed AstraZeneca’sTagrisso（Osimertinib）展示了患有早期（IB，II和IIIA）表皮生长因子受体突变（EGFRM）非小细胞肺患者的辅助病人的无疾病存活率（DFS）的统计上显着和临床上有意义的改善用治疗意图完全肿瘤切除后癌症（NSCLC）。
Results will be presented during the plenary session of the American Society of Clinical Oncology ASCO20 Virtual Scientific Program on 31 May (abstract #LBA5).
In the primary endpoint of DFS in patients with Stage II and IIIA disease, adjuvant treatment (after surgery) withTagrissoreduced the risk of disease recurrence or death by 83% (based on a hazard ratio [HR] of 0.17; 95% confidence interval [CI] 0.12, 0.23; p<0.0001). DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001).
At two years, 89% of patients in the trial treated withTagrissoremained alive and disease free versus 53% on placebo. Consistent DFS results were seen across all subgroups, including patients who were treated with surgery followed by chemotherapy and those who received surgery only, as well as in Asian and non-Asian patients.
Roy S. Herbst, MD, Ph.D., chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, CT and principal investigator in the Phase III ADAURA trial, said: “These data are transformative for patients with early-stage EGFR-mutated non-small cell lung cancer who face high rates of recurrence even after successful surgery and subsequent treatment with adjuvant chemotherapy.Tagrisso将提供一项急需的新治疗选项，有可能改变药物的做法，并改善这种环境中患者的结果。“
肿瘤学副总裁JoséAboselga说：“III阶段Adaura审判的重要结果Tagrisso在全球试验中首次证明EGFR抑制剂可以改变早期EGFR-突变的肺癌的过程，并为治愈提供希望。我们正在与监管机构讨论这些优秀的数据，并期待提出福利Tagrissoto patients with early-stage disease.”
InApril 2020, an Independent Data Monitoring Committee recommended for the Phase III ADAURA trial to be unblinded two years early based on its determination of overwhelming efficacy. At the time of data cut-off, overall survival (OS) data favouredTagrisso, but were not mature. The trial will continue to assess OS as a secondary endpoint.
Summary of ADAURA results
i The data cut-off date for DFS was 17 January 2020.
The safety and tolerability ofTagrisso在这次试验中与先前的转移设置试验一致。所有原因的3级或更高级别的不良事件发生在10％的患者中Tagrissoarm versus 3% in the placebo arm as assessed by the investigator.
Tagrissois approved for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC in the US, Japan, China, the EU and many other countries around the world.
Several presentations featured during the ASCO20 Virtual Scientific Program will showcaseAstraZeneca’s leadership in lung canceracross early and late-stage disease and reinforce the Company’s biomarker-driven approach.
Lung cancer
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.1Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.2A significant portion of patients with resectable NSCLC eventually develop recurrence despite surgery (complete resection).3,4Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.5-7These patients are particularly sensitive to treatment with EGFR-tyrosine kinase inhibitors (TKIs) which block the cell-signalling pathways that drive the growth of tumour cells.8Approximately 25-30% of patients with NSCLC present with resectable disease at diagnosis.9-11
ADAURA
ADAURA is a randomised, double-blinded, global, placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC with complete tumour resection and adjuvant chemotherapy as indicated. In the experimental arm, patients were treated withTagrisso80mg一次每日口服片三年或直至疾病复发。该审判在20多个国家/地区，包括美国，在欧洲，南美，亚洲和中东地区的200多个中心的审判。初级终点是阶段II和IIIa患者的DFS，并且关键的辅助端点是阶段IB，II和IIIA患者的DFS。数据读数最初预期在2022年。试验将继续评估OS作为辅助端点。
Tagrisso
Tagrisso(osimertinib) is a third-generation, irreversible EGFR-TKI with clinical activity against CNS metastases.Tagrisso40mg and 80mg once-daily oral tablets have received approval in the US, Japan, China, the EU and many countries around the world for 1st-line EGFRm advanced NSCLC.Tagrissois also being developed in the Stage III, unresectable setting (LAURA), in combination with chemotherapy (FLAURA2) and in combination with potential new medicines to address resistance to EGFR-TKIs (SAVANNAH, ORCHARD).
欧洲杯微信买球肺癌中的阿拉西康
AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action. AstraZeneca aims to address the unmet needs of patients with EGFRm tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with the approved medicinesIressa(gefitinib) andTagrisso, and its ongoing Phase III trials LAURA, and FLAURA2.5-7
AstraZeneca is committed to addressing tumour mechanisms of resistance through the ongoing Phase II trials SAVANNAH and ORCHARD which testTagrisso结合savolitinib,选择性inhibitor of c-MET receptor tyrosine kinase, along with other potential new medicines.Enhertu（Trastuzumab Deruxtecan），HER2-定向的抗体药物缀合物正在开发转移性非鳞状HER2-过度抑制或HER2突变的NSCLC，包括与其他抗癌治疗组合的试验。
广泛的晚期免疫肿瘤学计划侧重于肺癌患者，没有可算法的遗传突变，该突变占所有肺癌患者的四分之三。12Imfinzi, an anti-PDL1 antibody, is in development for patients with advanced disease (Phase III trials POSEIDON and PEARL) and for patients in earlier stages of disease including potentially curative settings (Phase III trials MERMAID-1, AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC) both as monotherapy and in combination with tremelimumab and/or chemotherapy.Imfinzi也在第二阶段在第二阶段试验新ocoast，海岸和哈德逊以及来自早期管道的潜在新药的组合，包括Enhertu。
AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca's main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms - Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates - and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
欧洲杯微信买球
欧洲杯微信买球AstraZeneca（LSE / Sto / Nyse：AZN）是一家全球性的科学举例的生物制药公司，专注于处方药的发现，开发和商业化，主要用于治疗三项治疗区域的疾病 - 肿瘤，心血管，肾和新陈代谢和呼吸和免疫学。基于英国剑桥的基本，AstraZeneca在10欧洲杯微信买球0多个国家运营，其创新的药物被全球数百万患者使用。请拜访astrazeneca.com并在Twitter上遵循公司@欧洲杯微信买球。
Contacts
参考
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2. LUNGevity Foundation. Types of Lung Cancer. Available athttps://www.lungevity.org/about-lung-cancer/lung-cancer-101/types-of-lung-cancerAccessed: May 2020.
3. Sasaki H，et al.Prognosis of recurrent non‑small cell lung cancer following complete resection.Onc Letters.2014：7; 1300-1304。
4. Fink-Neuboeck N,et al.Hazards of Recurrence, Second Primary, or Other Tumor at Ten Years After Surgery for Non–Small-Cell Lung Cancer.临床肺癌。February 25 2020. https://doi.org/10.1016/j.cllc.2020.02.011.
5. Szumera-Ciećkiewicz A,et al.EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence.int J Clin Expolol。2013：6; 2800-12。
6. Keedy VL，et al.美国临床临床学会临时临床意见：表皮生长因子受体（EGFR）考虑先进的非小细胞肺癌患者患者的突变检测，考虑一线EGFR酪氨酸激酶抑制剂治疗。J Clin incol.。2011:29;2121-27.
7.埃里森G，et al.EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples.J Clin Pathol。2013：66; 79-89。
8. Cross DA等等。AZD9291是一种不可逆EGFR TKI，克服了肺癌中EGFR抑制剂的T790M介导的抗性。Cancer Discov。2014;4(9):1046-1061.
9. Cagle P,et al.肺癌生物标志物：现状和未来发展。Archives Pathology Lab Med。2013;137:1191–1198.
10. Datta D，et al.Preoperative Evaluation of Patients Undergoing Lung Resection Surgery.Chest。2003;123: 2096–2103.
11. Le Chevalier T.辅助化疗可重新入学非小细胞肺癌：它会在哪里？Ann Oncol.2010; 21：196-8。
12. Pakkala，S，et al.肺癌的个性化治疗：引人注目的目标。JCI Insight.。2018; 3（15）：E120858。
Adrian Kemp
Company Secretary
欧洲杯微信买球Astazeneca PLC