REG - GSK PLC - Efficacy results for GSK’s older adult RSV vaccine

GSKAnnouncement

13/10/2022 07:01

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RNS Number : 7296C  GSK PLC  13 October 2022

Issued: 13 October 2022, London UK

 

GSK's older adult respiratory syncytial virus (RSV) vaccine candidate shows
94.1% reduction in severe RSV disease and overall vaccine efficacy of 82.6% in
pivotal trial

 

·   Data to be presented at IDWeek 2022 showed overall vaccine efficacy
against RSV-lower respiratory tract disease (LRTD) in adults aged 60 years and
above, with a favourable safety profile

·   Consistent high vaccine efficacy observed against LRTD in severe
disease (94.1%), adults aged 70-79 years (93.8%) and in adults with underlying
comorbidities (94.6%)

·   High vaccine efficacy is consistent across RSV A and B strains

 

GSK plc (LSE/NYSE: GSK) today announced positive pivotal phase III trial
results for its respiratory syncytial virus (RSV) vaccine candidate for adults
aged 60 years and above to be presented at IDWeek 2022. The vaccine candidate
was highly efficacious, demonstrating overall vaccine efficacy of 82.6%
(96.95% CI, 57.9-94.1, 7 of 12,466 vs. 40 of 12,494) against RSV lower
respiratory tract disease (RSV-LRTD), meeting the trial's primary endpoint.

 

Consistent high vaccine efficacy was also observed across a range of
pre-specified secondary endpoints, highlighting the impact the vaccine
candidate could have on the populations most at risk of the severe outcomes of
RSV. Efficacy against severe RSV-LRTD, defined as LRTD with at least two lower
respiratory signs or assessed as severe by the investigator and confirmed by
the external adjudication committee, was 94.1% (95% CI, 62.4-99.9, 1 of 12,466
vs. 17 of 12,494). In participants with pre-existing comorbidities, such as
underlying cardiorespiratory and endocrinometabolic conditions, vaccine
efficacy was 94.6% (95% CI, 65.9-99.9, 1 of 4,937 vs. 18 of 4,861), with 93.8%
(95% CI, 60.2-99.9, 1 of 4,487 vs. 16 of 4,487) efficacy observed in adults
aged 70-79 years.

 

Vaccine efficacy against LRTD was consistent across both RSV-A and RSV-B
subtypes (84.6%; CI 32.1-98.3, 2 of 12,466 vs. 13 of 12,494 and 80.9%; CI
49.4-94.3, 5 of 12,466 vs. 26 of 12,494 respectively), consistent with the
robust neutralising antibody response generated against both subtypes. See
Figure 1: Vaccine efficacy against first episodes of RSV-confirmed LRTD and
RSV-confirmed ARI (modified exposed set).

 

Tony Wood, GSK Chief Scientific Officer, said: "These are truly exceptional
results given that today RSV remains one of the major infectious diseases
without a vaccine, despite over 60 years of research. We believe that with the
high vaccine efficacy demonstrated in this pivotal trial, our vaccine
candidate has the potential to help reduce the significant global burden of
RSV-associated disease in older adults, including those at the greatest risk
of severe outcomes due to their age or underlying comorbidities."

 

The vaccine was well tolerated with a favourable safety profile. The observed
solicited adverse events were typically mild-to-moderate and transient, the
most frequent being injection site pain, fatigue, myalgia, and headache.

 

Regulatory submissions based on the phase III data are anticipated in the
second half of 2022. GSK's RSV vaccine candidate for older adults contains a
recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined
with GSK's proprietary AS01(E) adjuvant. There are currently no RSV vaccines
approved anywhere in the world.

 

About the AReSVi-006 trial

The AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial is a
randomised, placebo-controlled, observer-blind, multi-country trial to
demonstrate the efficacy of a single dose of GSK's adjuvanted RSVPreF3 OA
investigational vaccine in adults aged 60 years and above. Approximately
25,000 participants were enrolled from 17 countries.

 

This phase III efficacy trial is part of a comprehensive RSV
evidence-generation programme conducted by GSK. It will continue to evaluate
an annual revaccination schedule and longer-term protection over multiple
seasons following one dose of the RSV vaccine candidate.

 

AReSVi-006 is closely monitored for safety, with safety data reviewed
internally and by an external Independent Data Monitoring Committee on an
ongoing basis.

 

The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant
licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.

 

About respiratory syncytial virus (RSV) in adults

RSV is a common contagious virus affecting the lungs and breathing passages.
It is one of the major remaining infectious diseases for which there is
currently no vaccine or specific treatment available for adults. Older adults
are at high risk for severe disease due to age-related decline in immunity and
underlying conditions. 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. RSV
causes over 420,000 hospitalisations each year and 29,000 deaths in adults in
industrialised countries. Adults with underlying conditions are more likely to
seek medical advice 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/about-us/) .

 

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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 in
the Company's Annual Report on Form 20-F for 2021, GSK's Q2 Results for 2022
and any impacts of the COVID-19 pandemic.

 

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