Imfinzi is first and only immunotherapy to show survival benefit in limited-stage small cell lung cancer in global Phase III trial, 将死亡风险降低27%. 安慰剂

Positive results from the 亚得里亚海 Phase III trial showed 澳门在线赌城娱乐’s Imfinzi (durvalumab) ​demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to 安慰剂 for patients with limited-stage small cell lung cancer (LS-SCLC) who had not progressed following standard-of-care concurrent chemoradiotherapy (cCRT).

These results will be presented today during the Plenary Session at the 2024 American Society of Clinical 肿瘤学 (ASCO) Annual Meeting (abstract #LBA5).

计划中的中期分析结果显示 Imfinzi reduced the risk of death by 27% versus 安慰剂 (based on an OS hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.57-0.93; p=0.0104). 估计中位OS为55.9个月 Imfinzi 与33.安慰剂组4个月. 估计57%的患者接受了 Imfinzi were alive at three years compared to 48% on 安慰剂. Imfinzi also reduced the risk of disease progression or death by 24% (based on a PFS HR of 0.76; 95% CI 0.61-0.95; p=0.0161)对比安慰剂. 中位PFS为16.6个月 Imfinzi 和9.安慰剂组2个月. 估计46%的患者接受了 Imfinzi had not experienced disease progression at two years compared to 34% on 安慰剂.

The OS and PFS benefits observed were generally consistent across key prespecified patient subgroups 包括 age, sex, race, 疾病的阶段¹ at diagnosis, prior radiation and whether patients received prophylactic cranial irradiation.

David R. Spigel, MD, Chief Scientific Officer at Sarah Cannon Research Institute and investigator in the trial, said: “The 亚得里亚海 results represent a breakthrough in limited-stage small cell lung cancer, a highly aggressive disease where recurrence rates are high and only 15 to 30 per cent of patients survive five years. Durvalumab is the first systemic treatment to show improved survival for these patients in decades and should become a new standard of care in this setting.”

Susan Galbraith, Executive Vice President, 肿瘤学 R&D, 澳门在线赌城娱乐, said: “The strong improvement in overall survival seen with Imfinzi after concurrent chemoradiotherapy is transformative in the treatment of limited-stage small cell lung cancer. These tremendous results underscore our ambition to drive up survival rates in this earlier-stage lung cancer setting, and we look forward to working with regulatory authorities to bring Imfinzi 尽快送到这些病人那里.”
 

结果总结:亚得里亚海

^​i 没有有价值的

安全概况 Imfinzi was generally manageable and consistent with the known profile of this medicine. 没有观察到新的安全信号. Grade 3 and 4 adverse events due to any cause occurred in 24.4%的患者接受 Imfinzi and 24.2%的患者接受安慰剂治疗.

Notes

小细胞肺癌
Lung cancer is the leading cause of cancer death among men and women and accounts for about one-fifth of all cancer deaths.² Lung cancer is broadly split into non-small cell lung cancer and SCLC, 约15%的病例被归类为SCLC, 一种高度侵袭性的疾病.^3-4

LS-SCLC (I-III期), which accounts for approximately 30% of SCLC diagnoses, is classified as SCLC that is generally only in one lung or one side of the chest.^5-6 LS-SCLC typically recurs and progresses rapidly despite initial response to standard-of-care chemotherapy and radiotherapy.^4,7 LS-SCLC的预后尤其差, as only 15-30% of patients will be alive five years after diagnosis.⁸

亚得里亚海
亚得里亚海试验是随机的, 双盲, 安慰剂对照, 多中心全球III期试验评估 Imfinzi 单药治疗, Imfinzi plus Imjudo (tremelimumab) versus 安慰剂 in the treatment of 730 patients with LS-SCLC who had not progressed following cCRT. In the experimental arms, patients were randomised to receive a 1500mg fixed dose of Imfinzi 有或没有 Imjudo 75mg every four weeks for up to four doses/cycles each, followed by Imfinzi 每4周一次，持续24个月.

双主要终点为PFS和OS Imfinzi 单药治疗与安慰剂. 主要次要终点包括OS和PFS Imfinzi plus Imjudo 与安慰剂相比，安全性和生活质量指标. The trial included 164 centres in 19 countries across North and South America, Europe and Asia.

Imfinzi 
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is currently approved in a number of countries across multiple types of lung cancer. Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiation therapy. Imfinzi is also approved for the treatment of extensive-stage SCLC and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC.

除了对肺癌的适应症， Imfinzi is approved in a number of countries in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo 不可切除的肝细胞癌(HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU and in previously treated patients with advanced 膀胱癌 in a small number of countries.

Since the first approval in May 2017, more than 220,000 patients have been treated with Imfinzi. 作为广泛发展计划的一部分， Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, 膀胱癌, 乳腺癌, several gastrointestinal cancers and other solid tumours.

澳门在线赌城娱乐治疗肺癌
澳门在线赌城娱乐 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. By defining new therapeutic targets and 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 and the next wave of innovations, 包括 Tagrisso (osimertinib)和 Iressa (吉非替尼); Imfinzi and Imjudo; 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.

澳门在线赌城娱乐 is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, 包括治疗之外的.

澳门在线赌城娱乐在免疫肿瘤学(IO)中的应用
澳门在线赌城娱乐 is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours.

澳门在线赌城娱乐 strives to redefine cancer care and help transform outcomes for patients with Imfinzi 作为一种单一疗法或与 Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, 包括细胞疗法和T细胞接合剂.

澳门在线赌城娱乐 is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. 有广泛的临床项目, the Company also champions the use of IO treatment in earlier 疾病的阶段s, 哪里有最大的治愈潜力.

澳门在线赌城娱乐在肿瘤学
澳门在线赌城娱乐 is leading a revolution in oncology with the ambition to provide cures for cancer in every form, 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. It is through persistent innovation that 澳门在线赌城娱乐 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.

澳门在线赌城娱乐 has the vision to redefine cancer care and, one day, 消除癌症作为死亡原因.

澳门在线赌城娱乐
澳门在线赌城娱乐(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, science-led biopharmaceutical company that focuses on the discovery, 发展, and commercialisation of prescription medicines in 肿瘤学, 罕见疾病, 和澳门第一赌城在线娱乐, 包括心血管, Renal & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门在线赌城娱乐 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 澳门在线赌城娱乐.com 并在社交媒体上关注公司 @澳门在线赌城娱乐.

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