GSK在ATS上发布新数据，继续推进呼吸医学和患者护理的未来-动脉网

GSK continues to advance the future of respiratory medicine and patient care with new data at ATS

葛兰素史克等信源发布 2025-05-02 20:24

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40+ abstracts across GSK’s inhaled and respiratory biologics portfolio

涵盖GSK吸入和呼吸生物制品组合的40多份摘要

Additional analyses from the MATINEE trial expands body of evidence for the reduction of COPD exacerbations, emergency department visits and/or hospitalisations with mepolizumab

MATINEE 试验的更多分析扩充了美泊利单抗减少 COPD 急性加重、急诊就诊和/或住院的证据体系。

Updated analyses evaluate the impact of twice-yearly dosing with depemokimab on asthma exacerbations, symptoms and quality of life among key patient subgroups

更新的分析评估了每半年一次使用depemokimab对关键患者亚组哮喘恶化、症状和生活质量的影响。

GSK plc (LSE/NYSE: GSK) today announced data from across its respiratory portfolio will be presented in 43 abstracts, including four late-breaking submissions, at the 2025 American Thoracic Society (ATS) International Congress in San Francisco (16 – 21 May). Key presentations aim to strengthen our understanding of optimal patient care to advance the prevention and treatment of diseases like asthma and chronic obstructive pulmonary disease (COPD)..

GSK plc（LSE/NYSE：GSK）今天宣布，将在2025年5月16日至21日于旧金山举行的美国胸科学会（ATS）国际会议上，通过43份摘要展示其呼吸系统产品组合的数据，其中包括四项最新突破性研究。重点报告旨在加深我们对最佳患者护理的理解，以推进哮喘和慢性阻塞性肺疾病（COPD）等疾病的预防和治疗。

Additional analyses from the MATINEE phase III trial

MATINEE III期试验的更多分析

The MATINEE trial, recently published in

MATINEE试验，最近发表在

The New England Journal of Medicine,

新英格兰医学杂志，

assessed the efficacy and safety of mepolizumab in a wide spectrum of patients with COPD and type 2 inflammation, characterised by blood eosinophil count, including the most severe and difficult to treat as categorised in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines..

评估了美泊利单抗在广泛范围内伴有2型炎症（以血液嗜酸性粒细胞计数为特征）的COPD患者中的疗效和安全性，包括根据《慢性阻塞性肺疾病全球倡议》（GOLD）指南分类的最严重且最难治疗的患者。

New sub-analyses expand body of evidence from MATINEE by evaluating the rate of COPD exacerbations, including those that lead to emergency department visits and/or hospitalisation. Key patient subgroups of interest were assessed including those with cardiovascular comorbidities, varying severities of airflow obstruction, and with chronic bronchitis, emphysema-only or both.

新的亚组分析通过评估慢性阻塞性肺病急性加重的发生率（包括导致急诊就诊和/或住院的情况）扩展了MATINEE研究的证据体系。重点评估了关键的患者亚组，包括那些伴有心血管合并症、不同程度气流阻塞以及患有慢性支气管炎、仅肺气肿或两者兼具的患者。

GSK will also present an analysis of the relationship between risk of severe exacerbation and healthcare burden in patients with COPD..

GSK还将介绍COPD患者严重恶化风险与医疗负担之间关系的分析。

Sub-analyses from the SWIFT-1 and SWIFT-2 phase III trials

SWIFT-1 和 SWIFT-2 III 期试验的子分析

Updates from

更新来自

SWIFT-1 and SWIFT-2, the trials assessing the efficacy and safety of twice-yearly dosing of depemokimab in asthma with type 2 inflammation, characterised by blood eosinophil count, include a post hoc analysis of exacerbations and quality of life in patients with uncontrolled symptoms. Data from a new pooled assessment highlight improvements in overall health and risk of exacerbations resulting from sustained suppression of type 2 inflammation.

SWIFT-1 和 SWIFT-2 试验评估了每半年一次给药的 depemokimab 在伴有 2 型炎症（以血液嗜酸性粒细胞计数为特征）的哮喘中的疗效和安全性，包括对未控制症状患者的恶化情况和生活质量进行的事后分析。来自新的综合评估的数据突显了由于持续抑制 2 型炎症而带来的整体健康改善和恶化风险的降低。

Further analyses from the SWIFT programme explored geographical variation in asthma exacerbation rate, including in China, where patients did not have access to respiratory biologics at the time of the trial..

SWIFT 计划的进一步分析探讨了哮喘急性加重率的地理差异，包括在中国的差异，当时患者在试验期间无法获得呼吸系统生物制剂。

GSK will also present in a late-breaking session a first of its kind, real-world study evaluating the relationship between biologic adherence and clinical outcomes, specifically exacerbations and oral corticosteroid use.

GSK还将在一个最新突破性会议中展示一项前所未有的真实世界研究，该研究评估了生物制剂依从性与临床结果之间的关系，特别是急性加重和口服皮质类固醇的使用。

Additional analyses demonstrate GSK ambition to lead advances in complex respiratory challenges

额外的分析表明了GSK在应对复杂呼吸系统挑战方面力求领先的雄心。

Analyses supporting development of camlipixant to treat the continued burden of refractory chronic cough (RCC), including a model-based dose–response meta‑analysis evaluating reduction in taste disturbance side effects, seen across the P2X3 class, with camlipixant.

支持开发camlipixant以治疗难治性慢性咳嗽（RCC）持续负担的分析，包括一项基于模型的剂量-反应荟萃分析，评估camlipixant在减少P2X3类药物常见的味觉障碍副作用方面的效果。

A real-world European cohort study evaluating the ambition of clinical remission in patients with severe asthma treated with mepolizumab.

一项评估美泊利单抗治疗重度哮喘患者临床缓解目标的现实世界欧洲队列研究。

New data showing the externally verified carbon footprints of salbutamol (also known as albuterol in the US) in the current metered dose inhaler (MDI) with propellant HFA-134a, a potential future MDI with next-generation candidate propellant HFA-152a, and a dry powder inhaler (DPI).

新数据显示了目前使用推进剂HFA-134a的定量吸入器（MDI）中的沙丁胺醇（在美国也称为albuterol）的经过外部验证的碳足迹，以及未来潜在的采用新一代候选推进剂HFA-152a的MDI和干粉吸入器（DPI）。

Full list of GSK’s key presentations at ATS 2025:

GSK在ATS 2025上的主要报告完整列表：

Abstract Name

抽象名称

Presenter

主持人

Presentation Details

演示详情

Mepolizumab

美泊利单抗

Mepolizumab Reduces the Risk of Severe Exacerbations and Healthcare Resource Utilization in Chronic Obstructive Pulmonary Disease: Results from the MATINEE Phase III Randomized Controlled Trial

美泊利单抗降低慢性阻塞性肺疾病严重急性加重和医疗资源利用的风险：MATINEE III期随机对照试验结果

Gerard J. Criner

杰拉德·J·克赖纳

Oral Presentation

口头报告

Abstract #10581

摘要 #10581

Session C14

C14节

Mepolizumab is Efficacious in Patients with Chronic Obstructive Pulmonary Disease Regardless of Airflow Obstruction Level: Post Hoc Analysis of the MATINEE Phase III Randomized Controlled Trial

无论气流阻塞水平如何，美泊利单抗对慢性阻塞性肺疾病患者均有效：MATINEE III期随机对照试验的事后分析

MeiLan K. Han

韩美兰

Poster Discussion

海报讨论

Abstract #8812

摘要 #8812

Poster Board #1017

海报板 #1017

Session B101

B101场次

Mepolizumab is Efficacious in Patients with Chronic Obstructive Pulmonary Disease Regardless of Investigator-Reported Chronic Bronchitis and/or Emphysema: Post Hoc Analysis of the MATINEE Phase III Randomized Controlled Trial

无论研究者报告的慢性支气管炎和/或肺气肿如何，美泊利单抗对慢性阻塞性肺疾病患者均有效：MATINEE III期随机对照试验的事后分析

Ian D. Pavord

伊恩·D·帕沃德

Poster Discussion

海报讨论

Abstract #8746

摘要 #8746

Poster Board #1012

海报板 #1012

Session B101

B101场次

Mepolizumab is Efficacious in Patients With Chronic Obstructive Pulmonary Disease Regardless of Disease Duration: Post Hoc Analysis of the MATINEE Phase III Randomized Controlled Trial

无论病程长短，美泊利单抗对慢性阻塞性肺疾病患者均有效：MATINEE III期随机对照试验的事后分析

Nicolas Roche

尼古拉斯·罗切

Late-breaker

最新消息

Poster Board #P657

海报板 #P657

Session C33

C33节

Camlipixant

坎利匹克ант

Investigating Camlipixant P2X3 Selectivity and Taste Disturbance: A Model-Based Dose–Response Meta-Analysis

研究Camlipixant P2X3选择性与味觉障碍：基于模型的剂量-反应荟萃分析

Daren Austin

达伦·奥斯汀

Thematic Poster

主题海报

Abstract #7825

摘要 #7825

Poster Board #P109

海报板 #P109

Session A54

会议 A54

Effect of Camlipixant on Cardiac Repolarization in Healthy Participants: A Thorough QT/QTc Study

坎利匹坦对健康参与者心脏复极的影响：一项全面的QT/QTc研究

Elizabeth A. Duncan

伊丽莎白·A·邓肯

Thematic Poster

主题海报

Abstract #8877

摘要 #8877

Poster Board #P108

海报板 #P108

Session A54

会议 A54

A Scoping Literature Review of Digital Endpoints for Chronic Cough Over the Past Five Years: Closing the Gap Between Clinical Trials and Real-World Clinical Practice

过去五年慢性咳嗽数字终点的范围文献综述：弥合临床试验与真实世界临床实践之间的差距

Elizabeth P. Skinner

伊丽莎白·P·斯金纳

Thematic Poster

主题海报

Abstract #7776

摘要 #7776

Poster Board #P256

海报板 #P256

Session B42

B42分会场

About mepolizumab

关于美泊利单抗

Mepolizumab is a monoclonal antibody that targets and binds to IL-5, a key messenger protein (cytokine) in type 2 inflammation. Mepolizumab has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation. It is currently approved for use in the US and Europe across four IL-5 mediated conditions.

美泊利单抗是一种单克隆抗体，靶向并结合IL-5，IL-5是2型炎症中的一种关键信使蛋白（细胞因子）。美泊利单抗被开发用于治疗一系列与2型炎症相关的IL-5介导的疾病。目前，它已在美国和欧洲获批用于四种IL-5介导的病症。

Mepolizumab is not approved for the treatment of COPD in any country. Regulatory submissions are under review in several countries, including the US, China and the EU. The US FDA has provided a PDUFA date of May 7, 2025..

美泊利单抗尚未在任何国家获批用于治疗慢性阻塞性肺疾病（COPD）。包括美国、中国和欧盟在内的多个国家正在审查监管提交。美国食品药品监督管理局（FDA）已给出2025年5月7日的PDUFA日期。

For product and important safety information please consult the country relevant summary of product characteristics.

有关产品和重要安全信息，请查阅与国家相关的特性概要。

EU available at:

欧盟可用地址：

https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf

。

About depemokimab

关于depemokimab

Depemokimab, a monoclonal antibody that targets IL-5, is the first ultra-long-acting biologic to be evaluated in phase III trials of patients with asthma with type 2 inflammation (SWIFT trials) or chronic rhinosinusitis with nasal polyps (CRSwNP) (the ANCHOR trials). Depemokimab's extended half-life, high-binding affinity and potency, supported six-month (26 week) dosing regimens in these trials, and demonstrated early and sustained inhibition of markers of type 2 inflammation and IL-5 activity.

Depemokimab是一种靶向IL-5的单克隆抗体，是首个在三期临床试验中评估的超长效生物制剂，适用于2型炎症哮喘患者（SWIFT试验）或伴鼻息肉的慢性鼻窦炎（CRSwNP）患者（ANCHOR试验）。Depemokimab具有延长的半衰期、高结合亲和力和效力，在这些试验中支持了六个月（26周）的给药方案，并展示了对2型炎症和IL-5活性标志物的早期和持续抑制作用。

The phase III programme includes evaluation of depemokimab in other IL-5 mediated diseases including eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES). The first phase III trials in severe asthma, SWIFT-1 and SWIFT-2, have been reported and published in the .

III 期项目包括评估 depemokimab 在其他 IL-5 介导的疾病中的效果，包括伴有嗜酸性肉芽肿的多血管炎 (EGPA) 和高嗜酸性粒细胞综合征 (HES)。重度哮喘的首个 III 期试验 SWIFT-1 和 SWIFT-2 已经报告并发表在。

The New England Journal of Medicine

新英格兰医学杂志

and the phase III trials in CRSwNP, ANCHOR-1 and ANCHOR -2 have been published in

慢性鼻窦炎伴鼻息肉（CRSwNP）的 III 期临床试验 ANCHOR-1 和 ANCHOR-2 已发布在

The Lancet

柳叶刀

. Depemokimab is an investigational product and is not approved for use in any country. Regulatory submissions are under review, including in the US, China, Japan and the EU.

Depemokimab 是一种研究性产品，尚未在任何国家获得使用批准。监管提交正在审查中，包括在美国、中国、日本和欧盟。

About GSK in respiratory

关于GSK在呼吸领域的信息

GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care, and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics, and inhaled medicines, GSK is focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease.

GSK继续基于数十年的开创性工作，致力于实现更宏大的治疗目标，开发下一代护理标准，并为数亿呼吸系统疾病患者重新定义呼吸医学的未来。凭借行业领先的呼吸系统产品组合和疫苗、靶向生物制剂及吸入药物的研发管线，GSK专注于改善各类哮喘和慢性阻塞性肺病（COPD）患者的治疗效果与生活质量，同时关注难以治愈的慢性咳嗽以及较为罕见的疾病如伴间质性肺病的系统性硬化症等。

GSK is harnessing the latest science and technology with the aim of modifying the underlying disease dysfunction and preventing progression..

GSK 正在利用最新的科学和技术，旨在改善潜在的疾病功能障碍并防止其进展。

About GSK

关于GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

GSK是一家全球生物制药公司，致力于联合科学、技术和人才，共同战胜疾病。欲了解更多信息，请访问gsk.com。

Cautionary statement regarding forward-looking statements

关于前瞻性声明的警示性声明

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q1 Results for 2025..

GSK提醒投资者，GSK所做的任何前瞻性声明或预测，包括本公告中所包含的内容，均受可能致使实际结果与预测结果存在重大差异的风险和不确定性的影响。这些因素包括但不限于GSK 2024年Form 20-F年度报告中“风险因素”部分以及GSK 2025年第一季度业绩报告中描述的内容。

References

参考文献

[1] Hoffman M. Lung Disease & Respiratory Health. COPD Stages and the GOLD Criteria. WebMD. Available at:

[1] 霍夫曼 M. 肺病与呼吸健康。COPD 分期与 GOLD 标准。WebMD。可访问于：

webmd.com/lung/copd/gold-criteria-for-copd

. 14 May 2023. Last accessed April 2025.

. 2023年5月14日。最后访问时间：2025年4月。

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