UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of June 2023
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued: 21 June 2023, London UK
GSK shares positive data
for Arexvy, its respiratory syncytial virus (RSV) older
adult vaccine, indicating protection over two RSV
seasons
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New
results from the ongoing AReSVi-006 phase III trial show vaccine
efficacy against RSV-lower respiratory tract disease and severe
disease over two full RSV seasons, including in participants with
underlying medical conditions
●
Safety
and reactogenicity data were consistent with initial results from
the phase III programme
●
The
clinical development programme will continue to evaluate longer
term follow up and the optimal timing for
revaccination
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, adjuvanted) against lower respiratory
tract disease (LRTD) caused by respiratory syncytial virus (RSV) in
adults aged 60 years and older over multiple RSV seasons and after
annual revaccination.
Efficacy of a single dose over two seasons
The results show that one dose of the vaccine is efficacious
against RSV-LRTD and severe LRTD over two full RSV
seasons.
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Vaccine efficacy
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Endpoint
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Season one efficacy
Primary endpoint: 6.7 months median follow up
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Mid-season two efficacy*
Descriptive secondary endpoint: 14 months median follow
up
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Cumulative efficacy over two seasons*
Confirmatory secondary endpoint: 18 months median follow
up
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RSV-LRTD
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82.6%
96.95% CI57.9-94.1
7 of 12,466 vs 40 of 12,494
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77.3%
95% CI, 60.2-87.9
15 of 12,469 vs 85 of 12,498
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67.2%
97.5% CI, 48.2-80.0
30 of 12,469 vs 139 of 12,498
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Severe LRTD
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94.1%
95% CI, 62.4-99.9
1 of 12,466 vs 17 of 12,494
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84.6%
95% CI, 56.4-96.1
4 of 12,469 vs 33 of 12,498
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78.8%
95% CI, 52.6-92.0
7 of 12,469 vs 48 of 12,498
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*The vaccine efficacy is estimated using a Poisson model adjusted
by age, region and season.
A similar pattern of vaccine efficacy
over two seasons was also observed in adults with underlying
comorbidities and
in advancing age, reinforcing the impact the vaccine could have on
those most at risk of the severe outcomes of
RSV.
Revaccination
The trial also evaluated efficacy following an annual revaccination
schedule as a confirmatory secondary endpoint. Cumulative efficacy
over two seasons in participants who received a second dose of the
vaccine was 67.1% (97.5% CI, 48.1-80.0, 30 of 12,469 vs 139 of
12,498), suggesting revaccination after 12 months does not appear
to confer additional benefit for the overall population. The
clinical development programme will continue to evaluate longer
term follow up and the optimal timing for
potential revaccination.
Tony Wood, Chief Scientific Officer, GSK, said:
"Our goal is to provide a high level of protection for older adults
most at risk from RSV. These data show the efficacy of a single
dose of our vaccine over two RSV seasons against RSV-LRTD,
including in the populations most at risk due to age or underlying
medical conditions. This reinforces our confidence in its potential
to make a significant public health impact. We look forward to
discussing these results with regulators and vaccine recommending
bodies and to collecting more data from the ongoing clinical
development programme."
Safety and reactogenicity data were consistent with initial
observations from the phase III programme. The vaccine was
generally well tolerated. The most frequently observed adverse
events were injection site pain, fatigue, myalgia, headache, and
arthralgia. These were generally mild to moderate and
transient.
GSK will present these data at the US
Centers for Disease Control and Prevention's
(CDC) Advisory
Committee on Immunization Practices (ACIP) meeting on 21 June 2023.
Data from two influenza co-administration trials (quadrivalent
high dose and quadrivalent adjuvanted) will
also be presented, adding to the seasonal quadrivalent influenza
vaccination co-administration data in the current US product
label. These
data will be submitted to the US Food and Drug Administration (FDA)
and other regulators for review.
About AReSVi-006
This is a randomised, placebo-controlled, observer-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. Approximately 25,000 participants were enrolled
from 17 countries. The trial's primary endpoint was vaccine
efficacy against RSV-LRTD after one RSV season. Initial results
were published in the New England
Journal of Medicine in February
2023: https://www.nejm.org/doi/full/10.1056/NEJMoa2209604.
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 seasons and vaccine efficacy
after annual revaccination were confirmatory secondary
endpoints.
About Arexvy (respiratory syncytial virus vaccine,
adjuvanted)
Respiratory syncytial virus vaccine, adjuvanted, contains recombinant glycoprotein
F stabilised in the prefusion conformation (RSVPreF3). This antigen
is combined with GSK's proprietary AS01E adjuvant.
The vaccine was approved by the US FDA on 3 May 2023 for the
prevention of LRTD caused by RSV in individuals 60 years of age and
older.
In June 2023, the European Commission authorised the vaccine for active immunisation for the
prevention of LRTD caused by RSV in adults aged 60 years and older.
Regulatory reviews in Japan and other counties are
ongoing.
The vaccine is not approved anywhere else in the world. The
proposed trade name remains subject to regulatory approval in other
markets.
The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON
adjuvant licensed from Antigenics Inc., a wholly owned subsidiary
of Agenus Inc.
Please see the full US Prescribing Information:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF
About RSV in older adults
RSV is a common contagious virus affecting the lungs and breathing
passages. Older adults are at high risk for severe disease due in
part to age-related decline in immunity, and older adults with
underlying conditions are at even greater risk for severe disease.
RSV can exacerbate conditions, including chronic obstructive
pulmonary disease (COPD), asthma, and chronic heart failure and can
lead to severe outcomes, such as pneumonia, hospitalisation, and
death. Each year, approximately 177,000 adults 65 years and older
are hospitalised in the US due to RSV; an estimated 14,000 cases
result in death.1 For
adults 60 and older, data suggest an increased risk for severe RSV
infection that can lead to hospitalisation.2,3 Adults
with underlying conditions are more likely to seek medical services
and have higher hospitalisation rates than adults without these
conditions.
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/company.
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GSK enquiries
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Media:
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Tim Foley
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+44 (0) 20 8047 5502
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(London)
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Simon Moore
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+44 (0) 20 8047 5502
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(London)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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Alison Hunt
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+1 540 742 3391
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(Washington DC)
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Investor Relations:
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Nick Stone
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+44 (0) 7717 618834
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Mick Readey
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+44 (0) 7990 339653
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(London)
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Josh Williams
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+44 (0) 7385 415719
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(London)
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Camilla Campbell
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+44 (0) 7803 050238
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(London)
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Steph Mountifield
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+44 (0) 7736 063933
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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Frannie DeFranco
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+1 215 751 4855
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(Philadelphia)
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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 the company's Annual Report on Form 20-F for 2022,
GSK's Q1 Results for 2023 and any impacts of the COVID-19
pandemic.
Registered in England & Wales:
No.
3888792
Registered
Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1. Falsey AR, et al. N Engl J Med 2005; 352:1749-1759 DOI:
10.1056/NEJMoa043951. Accessed March 2023.
2. Tseng HF, Sy LS, Ackerson B, et al. Severe morbidity and short-
and mid- to long-term mortality in older adults hospitalized with
respiratory syncytial virus infection. J Infect Dis.
2020;222(8):1298-1310. doi:10.1093/infdis/jiaa361.
3. Belongia EA, King JP, Kieke BA, et al. Clinical features,
severity, and incidence of RSV illness during 12 consecutive
seasons in a community cohort of adults ≥60 years old. Open
Forum Infect Dis. 2018;5(12):ofy316.
doi:10.1093/ofid/ofy316.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: June
21, 2023
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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