Issued: 8 October 2024, London
UK
GSK
presents positive data for Arexvy, its respiratory syncytial
virus (RSV) vaccine, indicating protection over three RSV
seasons
· GSK's RSV vaccine is the only RSV vaccine with efficacy and
safety data available through 3 full seasons, including in people
at increased risk
· Safety and reactogenicity data are consistent with previous
results from phase III programme
· GSK will continue to provide data on longer term follow-up to
help recommending bodies determine future revaccination
schedules
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.
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. 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).
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. 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.
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]
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. We will continue
to provide data on longer term follow-up to help recommending
bodies determine future revaccination schedules."
|
Endpoint
|
Season one
efficacy*
|
Season two
efficacy
|
Season three
efficacy
|
Cumulative efficacy over
three seasons**
|
|
RSV-LRTD
|
Primary
confirmatory endpoint: 6.7 months median follow- up
82.6%
96.95%
CI, 57.9-94.1
7
of 12,466 vs 40 of 12,494
|
Secondary
descriptive endpoint: 6.3 months median follow-up
56.1%
95% CI,
28.2-74.4
20 of
4,991 vs 91 of 10,031
|
Secondary
descriptive endpoint: 7 months median follow-up
48.0%
95% CI,
8.7-72.0
16 of
4,988 vs 61 of 10,031
|
Secondary
confirmatory endpoint: 30.6 months median follow-up
62.9% - with season as
covariate***
97.5% CI,
46.7-74.8
48 of
12,468 vs 215 of 12,498
69.1% - without season as
covariate (post-hoc analysis)
97.5% CI,
55.8-78.9
48 of
12,468 vs 215 of 12,498
|
|
Severe LRTD
|
Secondary
descriptive endpoint
94.1%
95% CI,
62.4-99.9
1 of
12,466 vs 17 of 12,494
|
Secondary
descriptive endpoint
64.2%
95% CI,
6.19-89.2
5 of
4,991 vs 28 of 10,031
|
Secondary
descriptive endpoint
43.3%
95% CI,
-45.3-81.3
6 of
4,988 vs 21 of 10,031
|
Secondary
descriptive endpoint
67.4% - with season as
covariate***
95% CI,
42.4-82.7
15 of
12,468 vs 75 of 12,498
72.3 % - without season as
covariate (post-hoc analysis)
95% CI,
51.3 - 85.2
15 of
12,468 vs 75 of 12,498
|
|
RSV-LRTD in participants with at least 1 pre-existing
comorbidity of interest
|
Secondary
descriptive endpoint
94.6%
95% CI,
65.9-99.9
1 of
4,937 vs. 18 of 4,861
|
Secondary
descriptive endpoint
51.5%
95% CI,
7.4 - 76.6
12
of 1,981 vs 48 of 3,895
|
Secondary
descriptive endpoint
57.8
%
95% CI,
8.0-83.0
8 of
2,000 vs 37 of 3,924
|
Secondary
descriptive endpoint
64.7% - with season as
covariate***
95% CI,
45.1-78.1
25 of
5,014 vs 116 of 4,951
71.1% - without season as
covariate (post-hoc analysis)
95% CI,
55.2 - 82.0
25 of
5,014 vs 116 of 4,951
|
* 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.
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.
In addition to the presentation at
CHEST, the data will be submitted for scientific peer-reviewed
publication and to regulators for review.
About 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. 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]
After the first season, 12,467
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.
About GSK's RSV vaccine
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.
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. 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.
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.
The GSK proprietary AS01 adjuvant
system contains QS-21 STIMULON adjuvant licensed from Antigenics
Inc, a wholly owned subsidiary of Agenus Inc.
About 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
enquiries
|
|
|
|
|
Media:
|
Tim Foley
|
+44 (0) 20 8047 5502
|
(London)
|
|
|
Simon Moore
|
+44 (0) 20 8047 5502
|
(London)
|
|
|
Kathleen Quinn
|
+1 202 603 5003
|
(Washington DC)
|
|
|
Alison Hunt
|
+1 540 742 3391
|
(Washington DC)
|
|
|
|
|
|
|
Investor Relations:
|
Annabel Brownrigg Gleeson
|
+44 (0) 7901 101944
|
(London)
|
|
|
James Dodwell
|
+44 (0) 20 8047 2406
|
(London)
|
|
|
Mick Readey
|
+44 (0) 7990 339653
|
(London)
|
|
|
Camilla Campbell
|
+44 (0) 7803 050238
|
(London)
|
|
|
Steph Mountifield
|
+44 (0) 7736 063933
|
(London)
|
|
|
Jeff McLaughlin
|
+1 215 751 7002
|
(Philadelphia)
|
|
|
Frannie DeFranco
|
+1 215 751 4855
|
(Philadelphia)
|
Cautionary statement regarding forward-looking
statements
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 Q2 Results for 2024.
Registered in England & Wales:
No. 3888792
Registered Office:
79 New Oxford Street
London
WC1A 1DG
References