在亚得里亚海 III期试验中，57%接受Imfinzi治疗的患者在3年时存活
来自亚得里亚海 III期临床试验的积极结果显示，澳门葡京网赌游戏的治疗效果良好 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 与安慰剂相比，死亡风险降低了27%(基于OS风险比[HR]为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 与安慰剂组的48%相比，他们活了三年. Imfinzi 也使疾病进展或死亡的风险降低24%(基于PFS HR为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 与安慰剂组的34%相比，两年内没有疾病进展.
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 诊断时，既往放疗及患者是否接受预防性颅脑放疗.
David R. Spigel, MD, 莎拉·坎农研究所的首席科学官和试验的研究者, 他说:“亚得里亚海的结果代表了有限期小细胞肺癌的突破, 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，肿瘤学研究中心执行副总裁&澳门葡京网赌游戏的医学博士说:“总的生存率明显提高 Imfinzi 后同步放化疗是变革性的治疗有限期小细胞肺癌. These tremendous results underscore our ambition to drive up survival rates in this earlier-stage lung cancer setting, 澳门葡京赌博游戏期待着与监管机构合作，带来 Imfinzi 尽快送到这些病人那里.”
结果总结:亚得里亚海
|
Imfinzi (n=264) |
安慰剂 (n=266) |
|---|---|---|
OS |
||
中位OS，以月为单位(95% CI) |
55.9 (37.3-NEi) |
33.4 (25.5-39.9) |
风险比(95% CI) |
0.73 (0.57-0.93) |
|
假定值 |
0.0104 |
|
24个月时的OS率(%) |
68.0
|
58.5
|
36个月的OS率(%) |
56.5
|
47.6
|
PFS |
||
中位PFS，以月为单位(95% CI) |
16.6 (10.2-28.2) |
9.2 (7.4-12.9) |
风险比(95% CI) |
0.76 (0.61-0.95) |
|
假定值 |
0.0161 |
|
18个月时的PFS率(%) |
48.8
|
36.1
|
24个月时的PFS率(%) |
46.2
|
34.2
|
i 没有有价值的
安全概况 Imfinzi 总体上是可控的并且与该药的已知特征一致吗. 没有观察到新的安全信号. 因任何原因发生3级和4级不良事件24例.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 肺癌大致分为非小细胞肺癌和小细胞肺癌, 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), 约占SCLC诊断的30%, 被归类为SCLC，通常只发生在一个肺或胸部的一侧.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, 因为只有15-30%的患者在诊断后5年还活着.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. 在实验组中，患者被随机分配接受1500mg固定剂量的 Imfinzi 有或没有 Imjudo 每四个星期75mg，每次最多四个剂量/周期，然后 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. 该试验包括北美、南美、欧洲和亚洲19个国家的164个中心.
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, 对抗肿瘤的免疫逃避策略，释放对免疫反应的抑制.
Imfinzi 目前是否在多个国家被批准用于治疗多种类型的肺癌. 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 也被批准用于大分期SCLC的治疗，并与短疗程的 Imjudo 和化疗治疗转移性非小细胞肺癌.
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.
自2017年5月首次获批以来，已有超过22万名患者接受了治疗 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, 一些胃肠道癌症和其他实体肿瘤.
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, 同时也在推动科学的发展，以改善耐药和高级环境的结果. 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 (osimertinib)和 Iressa (吉非替尼); Imfinzi and Imjudo; 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免疫肿瘤学(IO)中的应用
澳门葡京网赌游戏 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.
澳门葡京网赌游戏致力于重新定义癌症治疗，并帮助改变癌症患者的治疗结果 Imfinzi 作为一种单一疗法或与 Imjudo 以及其他新的免疫疗法和模式. 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.
澳门葡京网赌游戏 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, 该公司还支持在早期疾病阶段使用IO治疗, 哪里有最大的治愈潜力.
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, 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, 有可能催化医学实践的变化，改变病人的体验.
澳门葡京网赌游戏的愿景是重新定义癌症治疗和, 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, 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, Renal & 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 and 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.
参考文献
1. 美国癌症阶段联合委员会.
2. 世界卫生组织. 国际癌症研究机构. 肺部情况说明. 可在:http://gco.iarc.who.int /媒体/ globocan /新闻/癌症/ 15-trachea-bronchus-and-lung-fact-sheet.pdf. 2024年5月发布.
3. LUNGevity基金会. 肺癌的种类. 可在:http://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. 2024年5月发布.
4. 国家癌症研究所. NCI词典-小细胞肺癌. 可在:http://www.cancer.gov /出版物/字典/ cancer-terms / def /小细胞肺癌. 2024年5月发布.
5. 美国癌症协会. 小细胞肺癌分期治疗选择. 可在:http://www.cancer.org/cancer/lung-cancer/treating-small-cell/by-stage.html. 2024年5月发布.
6. Senan S，等. 亚得里亚海: A phase III trial of durvalumab ± tremelimumab after concurrent chemoradiation for patients with limited stage small cell lung cancer. 安杂志. 2019; 30(增刊. 2):ii25.
7. 秦安，等. 复发性小细胞肺癌的治疗选择:澳门葡京赌博游戏取得了什么进展? J肿瘤学实践. 2018;14(6):369-370.
8. Bebb DG，等. 小细胞肺癌的症状和经验:对患者和护理人员的混合方法研究. Pulm其他. 2023;9:435-450.