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 October 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(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: 24 October 2024, London UK
New data for Arexvy, GSK's respiratory syncytial virus vaccine, show
potential to help protect a broader group of adults at increased
risk for RSV disease
●
Single
dose of vaccine elicited robust immune response with acceptable
safety profile in adults aged 18-49 at increased risk for
RSV-LRTD
●
Two
doses of vaccine in immunocompromised adults aged 18 and above
elicited immune responses similar to one dose in healthy adults
aged 50+ and with an acceptable safety profile
●
In
the US alone, adults aged 18-49 with at least one risk factor for
RSV disease could exceed 21 million[1]
GSK plc (LSE/NYSE: GSK) today announced new preliminary data
for Arexvy (respiratory
syncytial virus vaccine, recombinant adjuvanted) in
adults aged
18-49 at increased risk for RSV-LRTD due to certain underlying
medical conditions and in adults who are immunocompromised. These
data show the vaccine's potential to help protect a broader group
of adults at risk from the potentially serious consequences of RSV.
In the US alone, the number of adults aged 18-49 with at least one
risk factor that could put them at risk for RSV disease could
exceed 21 million.1
The vaccine is currently approved for use in adults aged 60 and
above in over 50 countries, and in adults aged 50-59 at increased
risk in a number of countries including the US and Europe*. There
are currently no RSV vaccines recommended for adults younger than
60 years of age who are at increased risk for RSV disease, despite
the burden of disease in this population.
Tony Wood, Chief Scientific Officer, GSK, said: "These promising data add to the evidence
supporting GSK's RSV vaccine and could help expand protection to
more adults at risk from RSV disease. They also provide valuable
insights into the potential impact of a second dose for certain
populations. We're committed to working with health authorities and
regulators to help adults at increased risk of RSV disease benefit
from vaccination."
In the phase IIIb trial (NCT06389487[2])
a single dose of the vaccine elicited robust immune responses in
adults aged 18-49 at increased risk for RSV-LRTD due to certain
underlying medical conditions (n=395). The immune response was
non-inferior to that observed in adults aged 60 and above (n=417),
meeting the trial's co-primary endpoints.
In the phase IIb trial (NCT05921903[3])
a single dose of the vaccine showed a robust immune response in
adults aged 18 and above who are immunocompromised due to kidney or
lung transplant (n=131), with a second dose (n=130) eliciting
responses similar to those of healthy adults aged 50 and older who
received one dose (n=125). These immune responses were consistent
for RSV-A and RSV-B subtypes in all groups (those who received 1 or
2 doses). These data will be presented today at the meeting of the
CDC's Advisory Committee on Immunization
Practices.
In both studies, the safety and reactogenicity data were consistent
with results from the phase III programme that have supported the
initial approval of the vaccine. The most common local adverse
event was pain, and most common systematic adverse events were
fatigue, myalgia, arthralgia and headache, most of which were
transient and mild in intensity.
RSV is a common, contagious virus that can cause severe respiratory
illness and
impacts an estimated 64 million people of all ages globally every
year.[4] Immunocompromised
people and those with
certain underlying medical conditions, such as chronic obstructive
pulmonary disease (COPD), asthma, heart failure and diabetes are at
increased risk for severe consequences from an RSV infection
compared to those without these conditions,[5], [6] including
having a higher risk of mortality.[7]
Final results from these trials will be presented at upcoming
medical conferences and submitted for peer-reviewed publication.
The final data will also be submitted to the US Food and Drug
Administration (FDA) and other regulators to support potential
label updates.
About the trial designs
NCT06389487 is
a phase IIIb open-label study to evaluate the non-inferiority of
the immune response and to evaluate the safety of the GSK's RSV
vaccine in adults aged 18-49 at increased risk for RSV
disease (n=395) compared
to adults aged 60 and older (n=417). 1,457
participants were enrolled across 52 locations in 6
countries.
The trial's co-primary endpoints were RSV-A and RSV-B
neutralisation titers expressed as mean geometric titer ratio
(relative to older adults over adults at increased risk) and
sero-response in RSV-A and RSV-B neutralising titers one month post
vaccine administration. There were also safety and immunogenicity
secondary endpoints. An additional cohort of 601 participants aged
18-49 were followed up for adverse events separate to safety follow
up of the initial cohort. The
study is ongoing to
collect further safety and immunogenicity data up to 6 months post
vaccination and is expected
to finish in 2025.
NCT05921903 is
a phase IIb, randomized, controlled, open-label, multi-country
study to evaluate the immune response and safety of GSK's RSV
vaccine in adults (≥18 years of age) who are
immunocompromised due to lung and renal transplant, comparing 1
versus 2 doses (1
dose, n=131, 2 doses, n=130) one
month (30-42
days) after the second vaccine administration compared
to a control group of non-immunocompromised adults aged 50 and
above receiving a single dose of GSK's RSV
vaccine (n=125
non-immunocompromised adults aged 50 and above). 386
participants were enrolled across 48 locations in 8
countries.
The trial's co-primary endpoints were RSV-A and RSV-B
neutralisation titers following a first and a second dose of GSK's
RSV vaccine expressed as mean geometric increase post dose 2
relative to post dose 1 at approximatively one month. There were
also safety and immunogenicity secondary endpoints. The study is
ongoing to collect further safety and immunogenicity data up to 12
months post last dose and is expected to finish in
2025.
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.
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 vaccine has been approved for the prevention of RSV-LRTD in
individuals 60 years of age and older in more than 50 countries,
including Europe, Japan and US. In addition, it is approved in the
US and EU/EEA countries 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 GSK proprietary AS01 adjuvant system contains STIMULON QS-21
adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of
Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary
of Agenus.
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)
7796 707505
|
(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
Notes:
*
European Union member states, as well as in the European Economic
Area (EEA) countries Iceland, Norway and
Liechtenstein.
References
[1] Based
on a study focusing on US adults aged 20-49. Among adults aged
20-49 years in the US, a total of 17.0% (N=21 million/125 million)
had at least one diagnosed risk factor for severe RSV disease
(including CHF, CHD, stroke, angina, MI, COPD, current asthma,
diabetes, current liver disease, and/or renal disease) - in E.Horn
et al, "Characteristics Associated with the Presence of One or More
Risk Factors for Severe Respiratory Syncytial Virus Disease among
Adults in the United States", poster presented at ID Week poster
[available on demand: P691 -
https://idweek2024.eventscribe.net/index.asp]
[2] Clinicaltrials.gov,
"A Study on the Immune Response and Safety of Vaccine Against
Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of
Age at Increased Risk for Respiratory Syncytial Virus Disease,
Compared to Older Adults 60 Years of Age and Above" - available at:
https://clinicaltrials.gov/study/NCT06389487
[3] Clinicaltrials.gov,
"A Study on the Immune Response and Safety of an RSV Vaccine When
Given to Adults 18 Years of Age and Above Who Received Lung or
Kidney Transplant and Are at an Increased Risk of Respiratory
Syncytial Virus Lower Respiratory Tract Disease and Compared to
Healthy Adults 50 Years of Age and Above (RSV OA=ADJ-023)" -
available at:
https://clinicaltrials.gov/study/NCT05921903
[4] National
Institute of Allergy and Infectious Diseases, Respiratory Syncytial
Virus (RSV). Available at: https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv -
last accessed: September 2024
[5] Branche
AR et al., Incidence of Respiratory Syncytial Virus Infection Among
Hospitalized Adults, 2017-2020 in Clinical
Infectious Diseases,
2022:74:1004-1011
[6] CDC,
Clinical overview of RSV. Available at: https://www.cdc.gov/rsv/hcp/clinical-overview/index.html.
Last accessed: October 2024
[7] A.Njue
et al., "Systematic Literature Review of Risk Factors for Poor
Outcomes Among Adults With Respiratory Syncytial Virus Infection in
High-Income Countries" in Open Forum
Infectious Diseases, Volume 10, Issue 11, November
2023, ofad513,
https://doi.org/10.1093/ofid/ofad513
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.
|
|
GSK plc
|
|
|
(Registrant)
|
|
|
|
|
Date: October
24, 2024
|
|
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
|
|
Victoria Whyte
|
|
|
Authorised
Signatory for and on
|
|
|
behalf
of GSK plc
|