REG - GSK PLC - New positive Arexvy data in younger adults at risk

GSKAnnouncement

24/10/2024 07:00

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RNS Number : 3884J  GSK PLC  24 October 2024

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  (#_edn1) ))

 

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  (#_edn2) ) 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  (#_edn3) ) 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 
(#_edn4) 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  (#_edn5) (,
 6  (#_edn6) ) including having a higher risk of mortality. 7  (#_edn7)

 

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 AS01(E) 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.

 

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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 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:

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WC1A 1DG

 

Notes:

* European Union member states, as well as in the European Economic Area (EEA)
countries Iceland, Norway and Liechtenstein.

 

References

 1  (#_ednref1) 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  (#_ednref2) 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  (#_ednref3) 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  (#_ednref4) National Institute of Allergy and Infectious Diseases,
Respiratory Syncytial Virus (RSV). Available at:
https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv
(https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv)
- last accessed: September 2024

 5  (#_ednref5) Branche AR et al., Incidence of Respiratory Syncytial Virus
Infection Among Hospitalized Adults, 2017-2020 in Clinical Infectious
Diseases, 2022:74:1004-1011

 6  (#_ednref6) CDC, Clinical overview of RSV. Available at:
https://www.cdc.gov/rsv/hcp/clinical-overview/index.html
(https://www.cdc.gov/rsv/hcp/clinical-overview/index.html) . Last accessed:
October 2024

 7  (#_ednref7) 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

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