GSK plc (LSE/NYSE: GSK) today announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial evaluating the efficacy of a single dose of Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older, including those at increased risk over three full RSV seasons (NCT04886596).1 These data will be presented today at the CHEST 2024 Annual Meeting, organised by the American College of Chest Physicians..

葛兰素史克公司（GSK plc）（伦敦证券交易所/纽约证券交易所股票代码：GSK）今天公布了AReSVi-006（成人呼吸道合胞病毒）III期试验的新数据，该试验评估了单剂量Arexvy（呼吸道合胞病毒疫苗，重组佐剂）对60岁及以上成人（包括三个完整RSV季节的高危人群）预防呼吸道合胞病毒（RSV）引起的下呼吸道疾病（LRTD）的疗效（NCT04886596）。 1 这些数据将于今天在美国胸科医师学会举办的 CHEST 2024 年会上公布。

Arexvy is the world’s first RSV vaccine and was approved based on exceptional efficacy in adults aged 60 and older, including those who are at increased risk due to certain underlying medical conditions. Today's results indicate that after a single dose of GSK’s RSV vaccine, cumulative efficacy over three full RSV seasons was clinically meaningful at 62.9% against RSV-LRTD (97.5% CI, 46.7-74.8, 48 of 12,468 vs 215 of 12,498) and 67.4% against severe RSV-LRTD (95% CI, 42.4-82.7, 15 of 12,468 vs 75 of 12,498) compared to placebo.

Arexvy是世界上第一种RSV疫苗，基于对60岁及以上成年人（包括那些由于某些潜在疾病而风险增加的成年人）的特殊疗效而获得批准。今天的结果表明，在单剂GSK的RSV疫苗后，三个完整的RSV季节的累积疗效对RSV-LRTD具有临床意义，为62.9%（97.5%CI，46.7-74.8，12468个中的48个对12498个中的215个），与安慰剂相比，对严重RSV-LRTD（95%CI，42.4-82.7，12468个中的15个对12498个中的75个）的累积疗效为67.4%。

In the third season, the vaccine’s efficacy was 48.0% against RSV-LRTD (95% CI, 8.7-72.0, 16 of 4,988 vs 61 of 10,031)..

在第三个季节，疫苗对RSV-LRTD的疗效为48.0%（95%CI，8.7-72.0，4988人中有16人，10031人中有61人）。

These results include efficacy against different RSV subtypes, in adults with advancing age (70-79 years of age), and those with certain underlying medical conditions. Since RSV can exacerbate medical conditions and potentially lead to hospitalisations, cumulative efficacy over three RSV seasons has the potential for significant health impact.

由于RSV会加剧医疗状况并可能导致住院治疗，因此三个RSV季节的累积疗效可能会对健康产生重大影响。

It has the potential to offer health care professionals flexibility to administer the vaccine year-round. Over time, revaccination is expected to be required to maintain an optimal level of protection. GSK will continue to share efficacy and immune response data, including on revaccination, with recommending bodies to inform decisions on immunisation schedules and future revaccination..

它有可能为医疗保健专业人员提供全年接种疫苗的灵活性。随着时间的推移，预计需要重新接种才能保持最佳的保护水平。葛兰素史克将继续与推荐机构分享疗效和免疫反应数据，包括再接种数据，以告知有关免疫接种时间表和未来再接种的决定。。

RSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year.2 Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age. RSV can exacerbate multiple conditions, including COPD, asthma, and chronic heart failure, and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.3 Each year RSV causes over 465,000 hospitalisations and 33,000 deaths in adults aged 60 and older in high-income countries.4.

RSV是一种常见的传染性病毒，影响肺部和呼吸道，每年影响全球约6400万人。2由于合并症，免疫缺陷状态或高龄，成年人患RSV疾病的风险可能会增加。RSV可以加剧多种疾病，包括COPD，哮喘和慢性心力衰竭，并可能导致严重的后果，如肺炎，住院和死亡[3]。每年RSV导致高收入国家60岁及以上成年人超过465000例住院和33000例死亡。

Tony Wood, Chief Scientific Officer, GSK, said: “We are excited by these new data which show that a single dose of Arexvy could help protect millions of older adults at risk of RSV disease over three seasons to benefit public health. This is the only RSV vaccine with efficacy and safety data available through three full seasons.

葛兰素史克（GSK）首席科学官托尼·伍德（TonyWood）表示：“我们对这些新数据感到兴奋，这些数据表明，单剂量的阿瑞克维（Arexvy）可以在三个季节内帮助保护数百万有呼吸道合胞病毒（RSV）疾病风险的老年人，从而有益于公共健康。这是唯一一种在三个完整季节内具有有效性和安全性数据的RSV疫苗。

We will continue to provide data on longer term follow-up to help recommending bodies determine future revaccination schedules.”.

我们将继续提供长期随访数据，以帮助推荐机构确定未来的重新接种时间表。”。

Endpoint

端点

Season one efficacy*

第一季功效*

Season two efficacy

第二季功效

Season three efficacy

第三季功效

Cumulative efficacy over three seasons**

**

RSV-LRTD

RSV-LRTD

Primary confirmatory endpoint: 6.7 months median follow- up

主要确诊终点：中位随访6.7个月

82.6%

82.6%

96.95% CI, 57.9–94.1

96.95%置信区间，57.9-94.1

7 of 12,466 vs 40 of 12,494

12466人中的7人对12494人中的40人

Secondary descriptive endpoint: 6.3 months median follow-up

次要描述性终点：中位随访6.3个月

56.1%

56.1%

95% CI, 28.2–74.4

95%置信区间，28.2-74.4

20 of 4,991 vs 91 of 10,031

4991人中有20人，10031人中有91人

Secondary descriptive endpoint: 7 months median follow-up

次要描述性终点：中位随访7个月

48.0%

48.0%

95% CI, 8.7-72.0

95%置信区间，8.7-72.0

16 of 4,988 vs 61 of 10,031

4988人中有16人，10031人中有61人

Secondary confirmatory endpoint: 30.6 months median follow-up

次要确诊终点：中位随访30.6个月

62.9% - with season as covariate***

62.9%——以季节为协变量***

97.5% CI, 46.7-74.8

97.5%置信区间，46.7-74.8

48 of 12,468 vs 215 of 12,498

12468人中的48人对12498人中的215人

69.1% - without season as covariate (post-hoc analysis)

69.1%——没有季节作为协变量（事后分析）

97.5% CI, 55.8-78.9

97.5%置信区间，55.8-78.9

48 of 12,468 vs 215 of 12,498

12468人中的48人对12498人中的215人

Severe LRTD

严重LRTD

Secondary descriptive endpoint

次要描述性终点

94.1%

94.1%

1 of 12,466 vs 17 of 12,494

12466个中的1个对12494个中的17个

Secondary descriptive endpoint

次要描述性终点

64.2%

64.2%

95% CI, 6.19–89.2

95%置信区间，6.19-89.2

5 of 4,991 vs 28 of 10,031

4991人中有5人，10031人中有28人

Secondary descriptive endpoint

次要描述性终点

43.3%

43.3%

95% CI, -45.3-81.3

95%置信区间，-45.3-81.3

6 of 4,988 vs 21 of 10,031

4988人中有6人，10031人中有21人

Secondary descriptive endpoint

次要描述性终点

67.4% - with season as covariate***

67.4%——以季节为协变量***

95% CI, 42.4-82.7

95%置信区间，42.4-82.7

15 of 12,468 vs 75 of 12,498

12468人中的15人对12498人中的75人

72.3 % - without season as covariate (post-hoc analysis)

72.3%——没有季节作为协变量（事后分析）

95% CI, 51.3 – 85.2

95%置信区间，51.3-85.2

15 of 12,468 vs 75 of 12,498

12468人中的15人对12498人中的75人

RSV-LRTD in participants with at least 1 pre-existing comorbidity of interest

RSV-LRTD在至少有1种预先存在的感兴趣合并症的参与者中

Secondary descriptive endpoint

次要描述性终点

94.6%

94.6%

95% CI, 65.9–99.9

95%置信区间，65.9-99.9

1 of 4,937 vs. 18 of 4,861

4937人中有1人，4861人中有18人

Secondary descriptive endpoint

次要描述性终点

51.5%

51.5%

95% CI, 7.4 – 76.6

95%置信区间，7.4-76.6

12 of 1,981 vs 48 of 3,895

1981年的12比3895年的48

Secondary descriptive endpoint

次要描述性终点

57.8 %

57.8 %

95% CI, 8.0-83.0

95%置信区间，8.0-83.0

8 of 2,000 vs 37 of 3,924

2000年的8比3924的37

Secondary descriptive endpoint

次要描述性终点

64.7% - with season as covariate***

64.7%——以季节为协变量***

95% CI, 45.1-78.1

95%置信区间，45.1-78.1

25 of 5014 vs 116 of 4951

5014的25比4951的116

71.1% - without season as covariate (post-hoc analysis)

71.1%——没有季节作为协变量（事后分析）

95% CI, 55.2 – 82.0

95%置信区间，55.2-82.0

25 of 5014 vs 116 of 4951

5014的25比4951的116

* The absolute values are being presented vaccinated group vs placebo group.** The vaccine efficacy is estimated using a Poisson model adjusted by age, region and season.*** Seasonality covariate means the data have been adjusted to reflect the variability of disease incidence between different seasons..

*绝对值是接种疫苗组与安慰剂组的比较。**疫苗效力是使用按年龄，地区和季节调整的泊松模型估算的。***季节性协变量意味着数据已经过调整，以反映不同季节之间疾病发病率的变化。。

Safety and reactogenicity data were consistent with previous results from the phase III programme. In season one, the vaccine was generally well tolerated. The most frequently observed adverse events were injection site pain, fatigue, myalgia, headache, and arthralgia within four days of vaccination..

安全性和反应原性数据与III期计划的先前结果一致。在第一季，疫苗的耐受性普遍良好。最常观察到的不良事件是接种疫苗后四天内注射部位疼痛，疲劳，肌痛，头痛和关节痛。。

In addition to the presentation at CHEST, the data will be submitted for scientific peer-reviewed publication and to regulators for review.

除了胸部展示之外，这些数据还将提交给科学同行评审出版物和监管机构审查。

About AReSVi-006

关于AReSVi-006

This is a randomised, placebo-controlled, double-blind, multi-country phase III trial to demonstrate the efficacy of a single dose of GSK's adjuvanted RSV older adult vaccine over three years and following an annual revaccination schedule in adults aged 60 years and above compared to placebo arm. About 25,000 participants have been enrolled from 17 countries.

这是一项随机，安慰剂对照，双盲，多国III期临床试验，旨在证明单剂量葛兰素史克佐剂RSV老年人疫苗在三年内的疗效，以及与安慰剂组相比，60岁及以上成年人的年度再接种时间表。来自17个国家的大约25000名参与者已经注册。

The trial’s primary endpoint was vaccine efficacy against RSV-LRTD after one RSV season. Results were published in the New England Journal of Medicine in February 2023.5.

该试验的主要终点是在一个RSV季节后针对RSV-LRTD的疫苗效力。研究结果发表在2023年2月的《新英格兰医学杂志》上。

After the first season, 12,469 participants in the vaccine arm were re-randomized to receive either the RSV vaccine or placebo and were followed up for occurrence of RSV-LRTD. Vaccine efficacy of a single dose against RSV-LRTD after two and three RSV seasons compared to placebo and vaccine efficacy after annual revaccination compared to placebo were confirmatory secondary endpoints..

在第一个季节之后，疫苗组的12469名参与者被重新随机分配接受RSV疫苗或安慰剂，并随访RSV-LRTD的发生。与安慰剂相比，在两个和三个RSV季节后，单剂量抗RSV-LRTD的疫苗效力以及与安慰剂相比，年度再接种后的疫苗效力是确证的次要终点。。

About GSK’s RSV vaccine

关于葛兰素史克的RSV疫苗

Respiratory Syncytial Virus Vaccine, Adjuvanted, contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant.

呼吸道合胞病毒疫苗（佐剂）含有稳定在融合前构象（RSVPreF3）中的重组RSV糖蛋白F。该抗原与GSK专有的AS01E佐剂结合。

In May 2023, GSK’s RSV vaccine was first approved by the US FDA for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. Since then, the vaccine has also been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 50 countries, including Europe and Japan.

2023年5月，美国FDA首次批准GSK的RSV疫苗用于预防60岁及以上人群中由呼吸道合胞病毒（RSV）引起的下呼吸道疾病（LRTD）。从那时起，该疫苗也被批准用于预防包括欧洲和日本在内的50个国家60岁及以上人群的RSV-LRTD。

In addition, it is approved in the US and EU for use in individuals aged 50-59 who are at increased risk due to certain underlying medical conditions. Regulatory reviews for this extended indication are also undergoing review in other countries – including Japan. The proposed trade name remains subject to regulatory approval in other markets..

此外，它在美国和欧盟被批准用于50-59岁的个人，这些人由于某些潜在的医疗条件而面临更高的风险。包括日本在内的其他国家也正在对这种扩展适应症进行监管审查。拟议的商品名仍需在其他市场获得监管部门的批准。。

The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees.

这种疫苗的使用应符合官方建议。与任何疫苗一样，可能不会在所有接种者中引发保护性免疫反应。

The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.

GSK专有的AS01佐剂系统包含QS-21刺激素佐剂，该佐剂由Agenus Inc.的全资子公司Antigenics Inc.许可。

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的生物制药公司，旨在联合科学、技术和人才共同战胜疾病。更多信息请访问gsk.com。