GSK plc (LSE/NYSE: GSK) today announced positive headline results from the phase III clinical trials ANCHOR-1 and ANCHOR-2, which assessed the efficacy and safety of depemokimab versus placebo in adults with CRSwNP. Both trials met their co-primary endpoints of a change from baseline in total endoscopic nasal polyp score at 52 weeks and change from baseline in mean nasal obstruction score from weeks 49 to 52.

GSK plc（LSE/NYSE:GSK）今天宣布了III期临床试验ANCHOR-1和ANCHOR-2的正面标题结果，该试验评估了depemokimab与安慰剂在CRSwNP成人中的疗效和安全性。两项试验均达到了共同的主要终点，即52周时内镜下鼻息肉总评分与基线相比发生了变化，49周至52周的平均鼻阻塞评分与基线相比发生了变化。

The overall incidence and severity of treatment-emergent adverse events across both trials were similar in patients treated with either depemokimab or placebo. Further analysis of these data is ongoing. The full results of ANCHOR-1 and ANCHOR-2 will be presented at an upcoming scientific congress..

在使用depemokimab或安慰剂治疗的患者中，两项试验中治疗紧急不良事件的总体发生率和严重程度相似。对这些数据的进一步分析正在进行中。ANCHOR-1和ANCHOR-2的全部结果将在即将举行的科学大会上公布。。

Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D at GSK, said: “Globally millions of people suffer from uncontrolled CRSwNP, the majority of whom will exhibit markers of type 2 inflammation. These patients have high corticosteroid exposure and often experience recurrence of nasal polyps following surgery.

葛兰素史克（GSK）呼吸/免疫学研发全球负责人高级副总裁凯万·卡凡迪（KaivanKhavandi）表示：“全球数百万人患有不受控制的CRSwNP，其中大多数人会表现出2型炎症标志物。这些患者皮质类固醇暴露量高，手术后经常会复发鼻息肉。

We're very encouraged by the results from the ANCHOR studies, which demonstrate the potential for depemokimab to offer targeted and sustained suppression of a key inflammatory pathway underlying nasal polyp growth and nasal obstruction. Today’s data, along with recent phase III data in severe asthma, will be used in regulatory filings around the world.'.

ANCHOR研究的结果让我们非常鼓舞，这些研究表明depemokimab有可能提供靶向和持续的抑制鼻息肉生长和鼻阻塞的关键炎症途径。今天的数据，以及最近严重哮喘的III期数据，将用于世界各地的监管文件。”。

Depemokimab is the first ultra-long-acting biologic to be evaluated in phase III trials with an extended half-life and high binding affinity and potency for interleukin-5 (IL-5), which could enable dosing once every six-months for patients with CRSwNP.1-3 IL-5 is present at high levels in nasal polyp tissue and is a key cytokine (protein) in type 2 inflammation.1,4-7.

Depemokimab是第一个在III期临床试验中评估的超长效生物制剂，对白细胞介素-5（IL-5）具有延长的半衰期和高结合亲和力和效力，可以使CRSwNP患者每六个月给药一次。1-3 IL-5在鼻息肉组织中高水平存在，是2型炎症中的关键细胞因子（蛋白质）[1,4-7]。

These data are part of GSK’s aspirations to advance treatment goals for those with type 2 inflammatory conditions like CRSwNP. Being able to deliver sustained suppression of inflammation that drives the disease and its progression, has the potential to benefit patients and clinicians by reducing the risk of inflammation reoccurring due to missed doses.

这些数据是葛兰素史克希望为CRSwNP等2型炎症患者推进治疗目标的一部分。能够持续抑制驱动疾病及其进展的炎症，有可能通过降低因错过剂量而再次发生炎症的风险而使患者和临床医生受益。

Increased dosing intervals may also reduce the need for regular clinic time..

增加给药间隔也可以减少对定期门诊时间的需求。。

CRSwNP is a chronic condition that affects up to 4% of the general population, of whom 40% have uncontrolled disease.8,9 It is caused by inflammation of the nasal lining that can lead to soft tissue growths, known as nasal polyps.4,10 People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pressure, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being.4,10  .

CRSwNP是一种慢性病，影响高达4%的普通人群，其中40%患有不受控制的疾病[8,9]。它是由鼻内衬炎症引起的，可导致软组织生长，称为鼻息肉[4,10]。患有CRSwNP的人会出现鼻塞，嗅觉丧失，面部压力，睡眠障碍，感染和鼻涕等症状，这些症状会显着影响他们的情绪和身体健康[4,10]。

Up to 80% of people with CRSwNP show evidence of type 2 airway inflammation, typically detected by blood eosinophil count as a biomarker, which is associated with more severe disease and symptoms.4-7,11These patients are likely to have a history of sinonasal surgery, which is accompanied by a high risk of nasal polyp recurrence and have high OCS use that is known to be associated with severe complications.7,10,11 .

高达80%的CRSwNP患者表现出2型气道炎症的证据，通常通过血液嗜酸性粒细胞计数作为生物标志物来检测，这与更严重的疾病和症状有关[4-7,11]。这些患者可能有鼻窦手术史，伴有鼻息肉复发的高风险，并且OCS使用率高，已知与严重并发症有关[7,10,11]。

Data from ANCHOR-1 and ANCHOR-2 along with data from SWIFT-1 and SWIFT-2, the phase III trials of depemokimab in severe asthma, will be used  in regulatory filings around the world. Depemokimab is currently not approved anywhere.

来自ANCHOR-1和ANCHOR-2的数据以及来自SWIFT-1和SWIFT-2的数据，这是depemokimab在严重哮喘中的III期试验，将用于世界各地的监管文件。。

About ANCHOR-1 and ANCHOR-21,2

关于ANCHOR-1和ANCHOR-21,2

ANCHOR-1 and ANCHOR-2 were replicate phase III clinical trials assessing the safety and efficacy of depemokimab in patients with CRSwNP. Both were 52-week, randomised, double-blind, parallel group, placebo controlled, multi-centre trials. Number of subjects included in the Full Analysis Set of ANCHOR-1: depemokimab = 143, placebo = 128 and in ANCHOR-2: depemokimab = 129, placebo = 128..

ANCHOR-1和ANCHOR-2是重复的III期临床试验，评估depemokimab在CRSwNP患者中的安全性和有效性。两者均为52周，随机，双盲，平行组，安慰剂对照，多中心试验。。。

About the depemokimab development programme

关于depemokimab开发计划

Depemokimab’s extended half-life, high potency and high binding affinity for IL-5 means it has the potential to provide sustained inhibition of broad inflammatory functions with dosing once every six-months. The phase III programme includes evaluation of depemokimab in other IL-5 mediated diseases. These include severe asthma,3,13,14 eosinophilic granulomatosis with polyangiitis (EGPA)14 and hypereosinophilic syndrome (HES).15 The first phase III trials in severe asthma, SWIFT-1 and SWIFT-2, have been reported and published in the New England Journal of Medicine.3.

Depemokimab的半衰期延长，效力高，对IL-5的结合亲和力高，这意味着它有可能通过每六个月一次的给药来持续抑制广泛的炎症功能。III期计划包括评估depemokimab在其他IL-5介导的疾病中的作用。这些包括严重哮喘，3,13,14嗜酸性肉芽肿伴多血管炎（EGPA）14和嗜酸性粒细胞增多综合征（HES）[15]。重症哮喘的第一阶段III期试验SWIFT-1和SWIFT-2已被报道并发表在新英格兰医学杂志上。

GSK in respiratory

呼吸系统中的GSK

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, we are 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.

葛兰素史克公司继续在数十年开创性工作的基础上，为数亿呼吸系统疾病患者提供更具雄心的治疗目标，制定下一代护理标准，并重新定义呼吸医学的未来。凭借业界领先的呼吸产品组合和疫苗、靶向生物制剂和吸入药物管道，我们专注于改善患有各种类型哮喘和COPD以及不太了解的难治性慢性咳嗽或罕见疾病（如系统性硬化症伴间质性肺病）的患者的预后和生活。

GSK is harnessing the latest science and technology with the aim to modify underlying disease dysfunction and prevent disease progression..

葛兰素史克利用最新的科学技术，旨在改变潜在的疾病功能障碍，预防疾病进展。。

About GSK

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.

葛兰素史克是一家全球性生物制药公司，旨在将科学、技术和人才团结起来，共同战胜疾病。更多信息请访问gsk.com。