REG - GSK PLC - Positive efficacy data of Arexvy over 3 seasons

GSKAnnouncement

08/10/2024 11:45

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RNS Number : 3649H  GSK PLC  08 October 2024

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  (#_edn1)
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 
(#_edn2) 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  (#_edn3)
Each year RSV causes over 465,000 hospitalisations and 33,000 deaths in adults
aged 60 and older in high-income countries. 4  (#_edn4)

 

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  Secondary descriptive endpoint: 6.3 months median follow-up  Secondary descriptive endpoint: 7 months median follow-up  Secondary confirmatory endpoint: 30.6 months median follow-up

                                                                                82.6%                                                        56.1%                                                        48.0%                                                      62.9% - with season as covariate***

                                                                                96.95% CI, 57.9-94.1                                         95% CI, 28.2-74.4                                            95% CI, 8.7-72.0                                           97.5% CI, 46.7-74.8

                                                                                 7 of 12,466 vs 40 of 12,494                                 20 of 4,991 vs 91 of 10,031                                  16 of 4,988 vs 61 of 10,031                                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                               Secondary descriptive endpoint                               Secondary descriptive endpoint                             Secondary descriptive endpoint

                                                                                94.1%                                                        64.2%                                                        43.3%                                                      67.4% - with season as covariate***

                                                                                95% CI, 62.4-99.9                                            95% CI, 6.19-89.2                                            95% CI, -45.3-81.3                                         95% CI, 42.4-82.7

                                                                                1 of 12,466 vs 17 of 12,494                                  5 of 4,991 vs 28 of 10,031                                   6 of 4,988 vs 21 of 10,031                                 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                               Secondary descriptive endpoint                               Secondary descriptive endpoint                             Secondary descriptive endpoint

                                                                                94.6%                                                        51.5%                                                        57.8 %                                                     64.7% - with season as covariate***

                                                                                95% CI, 65.9-99.9                                            95% CI, 7.4 - 76.6                                           95% CI, 8.0-83.0                                           95% CI, 45.1-78.1

                                                                                1 of 4,937 vs. 18 of 4,861                                    12 of 1,981 vs 48 of 3,895                                  8 of 2,000 vs 37 of 3,924                                  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 
(#_edn5)

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 AS01(E) 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.

 

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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.

 

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References

 1  (#_ednref1) Clinicaltrials.gov, "Efficacy Study of GSK's Investigational
Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above".
Available at: https://clinicaltrials.gov/study/NCT04886596 - last accessed:
September 2024

 2  (#_ednref2) 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

 3  (#_ednref3) Centers for Disease Control and Prevention (CDC), RSV in Older
Adults, 2024. Available at: https://www.cdc.gov/rsv/older-adults/index.html
(https://www.cdc.gov/rsv/older-adults/index.html) - Last accessed: September
2024

 4  (#_ednref4) Savic M, et al., "Respiratory syncytial virus disease burden
in adults aged 60 years and older in high-income countries: a systematic
literature review and meta-analysis", in Influenza Other Respir Viruses, 2023,
17(1):e13031, DOI: 10.1111/irv.13031

 5  (#_ednref5) Papi A. et al, "Respiratory Syncytial Virus Prefusion F
Protein Vaccine in Older Adults", in New England Journal of Medicine,
2023;388:595-608

DOI: 10.1056/NEJMoa2209604

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