REG - GSK PLC - Season two data for GSK Arexvy RSV OA vaccine

GSKAnnouncement

21/06/2023 07:00

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RNS Number : 3712D  GSK PLC  21 June 2023

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

 

·   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.

 

              Vaccine efficacy
 Endpoint     Season one efficacy                             Mid-season two efficacy*                                     Cumulative efficacy over two seasons*

              Primary endpoint: 6.7 months median follow up   Descriptive secondary endpoint: 14 months median follow up   Confirmatory secondary endpoint: 18 months median follow up

 RSV-LRTD     82.6%                                           77.3%                                                        67.2%

              96.95% CI57.9-94.1                              95% CI, 60.2-87.9                                            97.5% CI, 48.2-80.0

               7 of 12,466 vs 40 of 12,494                    15 of 12,469 vs 85 of 12,498                                 30 of 12,469 vs 139 of 12,498

 Severe LRTD  94.1%                                           84.6%                                                        78.8%

              95% CI, 62.4-99.9                               95% CI, 56.4-96.1                                            95% CI, 52.6-92.0

              1 of 12,466 vs 17 of 12,494                     4 of 12,469 vs 33 of 12,498                                  7 of 12,469 vs 48 of 12,498

*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
(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 AS01(E) 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
(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
(https://www.gsk.com/en-gb/company/) .

 

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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.

 

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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.

 

 

 

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