ANCHOR-1 and ANCHOR-2 phase III trials show improvements in nasal polyp size and obstruction for depemokimab with twice-yearly dosing versus placebo

ANCHOR-1 和 ANCHOR-2 三期试验显示，与安慰剂相比，每半年一次的 depemokimab 剂量在鼻息肉大小和阻塞方面有所改善。

Results with depemokimab were observed early at first assessment and sustained over 52 weeks

depemokimab 的结果在首次评估时就已显现，并在 52 周内保持稳定。

Late-breaking data presented at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress and simultaneously published in

2025年美国过敏、哮喘和免疫学学会（AAAAI）/世界过敏组织（WAO）联合大会发布的最新数据，同时发表于

The Lancet

柳叶刀

GSK plc (LSE/NYSE: GSK) today announced full results from the positive ANCHOR-1 and ANCHOR-2 phase III clinical trials assessing the efficacy and safety of depemokimab versus placebo (both with standard of care [SOC]) in adults with CRSwNP. Depemokimab is an investigational, ultra-long-acting monoclonal antibody targeting interleukin-5 (IL-5), a key cytokine (protein) in type 2 inflammation that presents in up to 85% of people with CRSwNP..

GSK plc（LSE/NYSE：GSK）今天宣布了ANCHOR-1和ANCHOR-2 III期临床试验的完整结果，这些试验评估了depemokimab与安慰剂（均采用标准治疗[SOC]）在CRSwNP成人患者中的疗效和安全性。Depemokimab是一种研究性超长效单克隆抗体，靶向白细胞介素-5（IL-5），这是2型炎症中的一种关键细胞因子（蛋白质），在高达85%的CRSwNP患者中存在。

1-5

1-5

Results from these studies were presented in a late-breaking oral abstract session at the 2025 AAAAI/WAO Joint Congress in San Diego, California and simultaneously published in

这些研究的结果在2025年加利福尼亚州圣地亚哥举行的AAAAI/WAO联合大会的最新突破性口头摘要会议中发布，并同时发表在

The Lancet.

柳叶刀。

ANCHOR-1 (N=271) and ANCHOR-2 (N=257) met their co-primary endpoints, with twice-yearly administration of depemokimab showing clinically meaningful and statistically significant improvements in nasal polyp size and nasal obstruction, two key clinical measures of disease severity, versus placebo.

ANCHOR-1（N=271）和 ANCHOR-2（N=257）达到了共同的主要终点，与安慰剂相比，每半年一次的depemokimab给药在鼻息肉大小和鼻塞方面显示出具有临床意义且统计学显著的改善，这两项是疾病严重程度的关键临床指标。

6,7

6,7

Additionally, a pooled analysis of the two trials showed improvements (reductions) from baseline versus placebo measured by:

此外，两项试验的汇总分析显示，与安慰剂相比，基线测量结果有所改善（减少），具体指标为：

Nasal polyp score (NPS, 0-8) at 52 weeks (treatment difference [95% CI], -0.7 [-0.9, -0.4], nominal p<0.001).

52周时的鼻息肉评分（NPS，0-8）（治疗差异 [95% CI]，-0.7 [-0.9, -0.4]，名义 p<0.001）。

Mean nasal obstruction scores (verbal response scale [VRS, 0-3]) over weeks 49-52 (treatment difference [95% CI], -0.24 [-0.39, -0.08], nominal p=0.003).

第49至52周的平均鼻塞评分（口头反应量表 [VRS，0-3]）（治疗差异 [95% CI]，-0.24 [-0.39, -0.08]，名义 p=0.003）。

ANCHOR-1 and ANCHOR-2 recruited a broad patient population with heterogenous symptom severity, reflective of real-world clinical practice. The treatment benefits were observed by the first assessment and sustained to week 52.

ANCHOR-1 和 ANCHOR-2 招募了症状严重程度各异的广泛患者群体，反映了真实世界的临床实践。治疗效果在首次评估时即被观察到，并持续至第 52 周。

6,7

6,7

Kaivan Khavandi, SVP and Global Head, Respiratory, Immunology/Inflammation R&D, said:

凯万·哈凡迪，高级副总裁兼全球负责人，呼吸、免疫/炎症研发部门，表示：

“Today’s data build on the body of evidence supporting depemokimab as an ultra-long-acting treatment and demonstrate significant reductions in nasal polyps with a twice-yearly dosing regimen. With nearly 40% of patients needing repeat surgeries and many requiring long-term systemic corticosteroids, there is a clear medical need for alternative treatment options to provide sustained symptom improvement and help alleviate the debilitating burden of this disease.” .

“今天的数据进一步充实了支持depemokimab作为一种超长效治疗方案的证据，并证明了每半年一次的给药方案能显著减少鼻息肉。近40%的患者需要重复手术，许多患者还需要长期使用全身性皮质类固醇，因此显然需要替代疗法来提供持续的症状改善，并帮助减轻该疾病的致残负担。”

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8,9

In pooled analyses of the secondary endpoints from both studies, nominally significant improvements in favour of depemokimab versus placebo were observed. These include changes from baseline in rhinorrhoea VRS score, loss of smell VRS score, in addition to the Lund-Mackay CT score, a sinus imaging assessment, and SNOT-22, a disease-related quality of life measure..

在两项研究的次要终点的汇总分析中，观察到 depemokimab 相较于安慰剂组名义上显著的改善。这些改善包括流涕 VRS 评分、嗅觉丧失 VRS 评分的变化，以及 Lund-Mackay CT 评分（一种鼻窦影像学评估）和 SNOT-22（一种与疾病相关的生活质量指标）。

6,7

6,7

By week 52 in the pooled ANCHOR studies, 74% (n=200) of patients in the depemokimab arm and 64% (n=164) patients in the placebo arm did not have intervention with SCS, surgery, or disease modulating medication (odds ratio [95% CI]: 0.58 [0.40, 0.86], nominal p=0.006).

在汇集的ANCHOR研究的第52周，depemokimab组74%（n=200）的患者和安慰剂组64%（n=164）的患者未接受SCS、手术或疾病调节药物的干预（比值比[95% CI]：0.58 [0.40, 0.86]，名义p=0.006）。

6,7

6,7

When considering intervention with surgery or disease modulating medication alone, the results still trended in depemokimab’s favour with 88% (n=239) of depemokimab-treated patients not having surgery or disease modulating medication vs. 83% (n=213) in the placebo group (hazard ratio [95% CI]: 0.713 [0.453, 1.124], p=0.146)..

当单独考虑手术或疾病调节药物干预时，结果仍然倾向于 depemokimab，88%（n=239）的接受 depemokimab 治疗的患者未进行手术或使用疾病调节药物，而安慰剂组为 83%（n=213）（风险比 [95% CI]：0.713 [0.453, 1.124]，p=0.146）。

The proportion of patients who experienced adverse events (AEs) was similar between the depemokimab and placebo groups in ANCHOR-1 (74% [n=106] versus 79% [n=101]) and ANCHOR-2 (76% [n=98] versus 80% [n=102]).

在ANCHOR-1（74% [n=106] 对比 79% [n=101]）和ANCHOR-2（76% [n=98] 对比 80% [n=102]）中，depemokimab组和安慰剂组经历不良事件（AEs）的患者比例相似。

6,7

6,7

These are consistent with results from SWIFT-1 and SWIFT-2, the phase III trials of depemokimab in patients with asthma with type 2 inflammation.

这些结果与 SWIFT-1 和 SWIFT-2 三期临床试验中针对 2 型炎症哮喘患者使用 depemokimab 的结果一致。

1

1

Additionally, <1% of patients (n=2) receiving depemokimab and 1% (n=3) on placebo, across both ANCHOR-1 and -2, discontinued treatment or withdrew from the study due to AEs. No serious adverse events were considered related to study treatment by investigators.

此外，在ANCHOR-1和-2试验中，接受depemokimab的患者中有<1%（n=2）以及接受安慰剂的患者中有1%（n=3）因不良事件停止治疗或退出研究。研究者认为没有严重不良事件与研究治疗相关。

6,7

6,7

CRSwNP is a chronic condition that affects up to 4% of the general population.

CRSwNP 是一种影响高达 4% 普通人群的慢性疾病。

5

5

The current SOC, including surgery and SCS use, is suboptimal to address the long-term impact of CRSwNP, and almost half of patients live with poorly controlled symptoms. Although short-term SCS temporarily improves symptoms, repeated use is known to cause serious adverse events such as increased risk of diabetes, cardiovascular disease, cataracts and osteoporosis.

目前的标准治疗（SOC），包括手术和短期使用糖皮质激素（SCS），并不能很好地解决CRSwNP的长期影响，近一半的患者仍生活在控制不佳的症状中。虽然短期使用SCS可以暂时缓解症状，但已知反复使用会导致严重不良事件，例如糖尿病、心血管疾病、白内障和骨质疏松症风险增加。

Surgery also improves symptoms, but up to 40% of patients experience recurrence of nasal polyps and symptoms within 18 months due to the underlying inflammation not fully suppressed by surgery..

手术也可以改善症状，但由于手术未能完全抑制潜在的炎症，多达40%的患者在18个月内会出现鼻息肉和症状的复发。

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10

Findings from ANCHOR-1 and -2, along with data from SWIFT-1 and SWIFT-2, are being used to support regulatory filings in both asthma with type 2 inflammation and CRSwNP in different countries around the world. Depemokimab is not currently approved in any country for either of these indications.

ANCHOR-1 和 -2 的研究结果以及 SWIFT-1 和 SWIFT-2 的数据正被用于支持在世界不同国家针对 2 型炎症性哮喘和慢性鼻窦炎伴鼻息肉（CRSwNP）的监管申请。Depemokimab 目前尚未在任何国家获批用于这两种适应症。

About ANCHOR-1 and ANCHOR-2

关于ANCHOR-1和ANCHOR-2

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6,7

The ANCHOR-1 and ANCHOR-2 clinical trials assessed the safety and efficacy of depemokimab in patients with CRSwNP. Both were global, 52-week, randomised, double-blind, parallel group, placebo controlled, multi-centre trials. The full analysis set in ANCHOR-1 included 143 patients in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm; in ANCHOR-2, 129 patients were included in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm..

ANCHOR-1 和 ANCHOR-2 临床试验评估了 depemokimab 在 CRSwNP 患者中的安全性和有效性。这两项试验均为全球性、为期 52 周、随机、双盲、平行组、安慰剂对照、多中心试验。在 ANCHOR-1 中，完整分析集包括 143 名接受 depemokimab 加标准治疗（SOC）的患者和 128 名接受安慰剂加 SOC 的患者；在 ANCHOR-2 中，129 名患者被纳入 depemokimab 加 SOC 组，128 名患者被纳入安慰剂加 SOC 组。

All 528 patients had inadequately controlled CRSwNP, including nasal polyps in both nasal cavities (an endoscopic bilateral NPS ≥5), and had either undergone previous surgery for CRSwNP, had received previous treatment with SCS or were intolerant to SCS. Patients received depemokimab or placebo at six-monthly intervals (26 weeks) in addition to SOC (maintenance intranasal corticosteroids)..

所有 528 名患者均患有控制不佳的 CRSwNP，包括双侧鼻腔息肉（内镜下双侧 NPS ≥5），并且曾经接受过 CRSwNP 手术、曾接受过 SCS 治疗或对 SCS 不耐受。患者在继续 SOC（维持性鼻用皮质类固醇）的同时，每六个月（26 周）接受 depemokimab 或安慰剂治疗。

About CRSwNP

关于CRSwNP

CRSwNP is caused by inflammation of the nasal lining that can lead to soft tissue growths, known as nasal polyps.

CRSwNP是由鼻腔内膜炎症引起的，可能导致软组织增生，称为鼻息肉。

8,9

8,9

People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being.

伴有鼻息肉的慢性鼻窦炎患者会出现鼻塞、嗅觉丧失、面部疼痛、睡眠障碍、感染和流鼻涕等症状，这些症状可能严重影响他们的情绪和身体健康。

2-4,10

2-4，10

IL-5 is a key cytokine (protein) in type 2 inflammation and is present in up to 85% of people with CRSwNP.

IL-5是2型炎症中的关键细胞因子（蛋白质），在高达85%的CRSwNP患者中存在。

2-5,10

2-5,10

IL-5 is frequently found in high concentrations in sinus and nasal polyp tissue of patients with CRSwNP and is associated with more severe disease.

IL-5常在伴有CRSwNP的患者的鼻窦和鼻息肉组织中发现高浓度，并与更严重的疾病相关。

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 CRSwNP. Depemokimab's extended half-life, high-binding affinity and potency, supported six-month (26 week) dosing regimens in the ANCHOR trials.

Depemokimab是一种靶向IL-5的单克隆抗体，是首个在CRSwNP患者III期试验中评估的超长效生物制剂。Depemokimab的延长半衰期、高结合亲和力和效力，在ANCHOR试验中支持了六个月（26周）的给药方案。

6,7

6,7

In these trials, depemokimab demonstrated early and sustained inhibition of blood eosinophils, a key marker of IL-5 activity.

在这些试验中，depemokimab 显示出对嗜酸性粒细胞的早期和持续抑制，这是 IL-5 活性的关键标志。

6,7,11

6，7，11

The phase III programme includes evaluation of depemokimab in other IL-5 mediated diseases. These include severe asthma, eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES).

III期项目包括评估depemokimab在其他IL-5介导的疾病中的效果。这些疾病包括重度哮喘、伴有多血管炎的嗜酸性肉芽肿病（EGPA）和高嗜酸性粒细胞综合征（HES）。

1,12,13, 14

1,12,13,14

The first phase III trials in severe asthma, SWIFT-1 and SWIFT-2, have been reported and published in the

重度哮喘的首个 III 期临床试验 SWIFT-1 和 SWIFT-2 已经被报道并发表在

New England Journal of Medicine

新英格兰医学杂志

.

。

1

1

GSK in respiratory

GSK在呼吸领域

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与疫苗、靶向生物制剂和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，同时关注较难治疗的顽固性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。

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

gsk.com

.

。

Footnote

脚注

[I] The term nominal significance refers to results with a p-value <0.05 where there was no control for multiple comparisons or where the test was performed after a break in the multiplicity hierarchy.

[I] 名义显著性是指具有p值<0.05的结果，其中未对多重比较进行控制，或在多重性层次结构中断后进行测试。

Cautionary statement regarding forward-looking statements

关于前瞻性声明的警告声明

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 under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Annual Report for 2024..

葛兰素史克提醒投资者，公司作出的任何前瞻性声明或预测，包括本公告中所作的声明或预测，均受到可能导致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葛兰素史克2023年Form 20-F年度报告第3.D项“风险因素”以及葛兰素史克2024年年度报告中描述的内容。

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. Accessed February 2025.

访问日期：2025年2月。

ClinicalTrials.gov. A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype (NIMBLE). Available at:

ClinicalTrials.gov。一项比较GSK3511294（Depemokimab）与美泊利单抗或贝那利珠单抗在具有嗜酸性粒细胞表型的重度哮喘患者中的研究（NIMBLE）。可用链接：

https://clinicaltrials.gov/study/NCT04718389

https://clinicaltrials.gov/study/NCT04718389

. Accessed February 2025.

访问日期：2025年2月。

ClinicalTrials.gov. Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA). Available at:

ClinicalTrials.gov. 在复发性或难治性嗜酸性肉芽肿伴多血管炎（EGPA）成人患者中，Depemokimab与Mepolizumab的疗效与安全性比较。可于以下网址获取：

https://clinicaltrials.gov/study/NCT05263934

https://clinicaltrials.gov/study/NCT05263934

. Accessed February 2025.

。访问时间：2025年2月。