REG - GSK PLC - MenABCWY vaccine preliminary phase III results
12/05/2023 10:00
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RNS Number : 2484Z GSK PLC 12 May 2023
Issued: 12 May 2023, London UK
GSK presents pivotal data at ESPID confirming effectiveness of its 5-in-1
meningococcal ABCWY vaccine candidate, with demonstrated coverage against a
panel of 110 MenB strains
· Preliminary results from phase III trial show all primary endpoints
met, demonstrating statistical non-inferiority compared to Bexsero
(meningococcal group B vaccine) and Menveo (meningococcal group A, C, W-135,
and Y conjugate vaccine), in individuals 10-25 years old with an acceptable
safety profile
· Only investigational 5-in-1 vaccine with demonstrated immunological
effectiveness against 110 diverse MenB invasive strains in a clinical trial
· If approved, this vaccine candidate could provide the broadest coverage
against the most prevalent meningococcal serogroups and could lead to a
simplified immunisation schedule
GSK plc (LSE/NYSE: GSK) today presented preliminary positive results from the
phase III trial (https://clinicaltrials.gov/ct2/show/NCT04502693) evaluating
the immunological vaccine effectiveness and safety of its MenABCWY combination
vaccine candidate, administered as two doses given six months apart in healthy
individuals aged 10-25 years. The preliminary data were disclosed at the 41st
Annual Meeting of the European Society for Paediatric Infectious Diseases
(ESPID) in Lisbon, Portugal.
The vaccine candidate demonstrated non-inferiority in primary endpoints for
five Neisseria meningitidis serogroups (A, B, C, W, and Y) compared to two
doses of Bexsero (meningococcal group B vaccine) and one dose of Menveo
(meningococcal group A, C, W-135, and Y conjugate vaccine) in 10-25-year-olds.
In addition, the vaccine candidate was generally well tolerated, with a safety
profile consistent with Bexsero and Menveo. In a separate confirmatory arm of
this phase III trial, the MenABCWY vaccine candidate showed immunological
effectiveness against a panel of 110 diverse meningococcal serogroup B (MenB)
invasive strains, which account for 95% of strains circulating in the US. 1
(#_edn1)
Tony Wood, Chief Scientific Officer at GSK, said: "These preliminary data
further unlock the potential of our MenABCWY vaccine candidate in providing
protection against invasive meningococcal disease caused by serogroups A, B,
C, W and Y. It's particularly encouraging to see the breadth of coverage
against the broadest panel of circulating MenB strains to date, as we know
MenB is the most common cause of meningococcal disease in the US with the
lowest immunisation rate."
Five Neisseria meningitidis serogroups (A, B, C, W, and Y) account for nearly
all invasive meningococcal disease (IMD) cases in most of the world. 2
(#_edn2) Meningitis B is currently the most common serogroup in the US and
accounts for more than half of meningococcal disease cases among
16-20-year-olds. 3 (#_edn3) (, 4 (#_edn4) ) Currently immunisation coverage
rates for Men B are estimated at approximately 31% of adolescents in the
US. 5 (#_edn5) GSK's MenABCWY vaccine candidate combines the antigenic
components of licensed meningococcal vaccines, Bexsero and Menveo. The aim of
combining two effective vaccines into one is to help simplify immunisation
schedules, which can in turn increase vaccination coverage and help reduce the
overall burden of disease.
Professor Terry Nolan, principal investigator for the phase III trial, and
Head of the Vaccine and Immunisation Research Group at the Peter Doherty
Institute for Infection and Immunity at the University of Melbourne, and
Murdoch Children's Research Institute, said: "Meningococcal vaccination can
help save lives and these results are significant in moving one step closer to
protection against five meningococcal serogroups with a single vaccine. The
potential for a simplified immunisation schedule could improve accessibility
for the target population susceptible to meningococcal disease."
GSK is working closely with regulatory agencies to review the full phase III
data set, including the supplemental Biologics License Application for Bexsero
for confirmation of full licensure under the Accelerated Approval pathway.
Detailed results will be submitted for publication in a peer-reviewed
scientific journal later this year.
About the MenABCWY phase III trial
The trial conducted by GSK is a phase III randomised, controlled,
observer-blind, multi-country trial to evaluate the safety, tolerability, and
immunogenicity of GSK's MenABCWY vaccine candidate. It is part of a
comprehensive programme to generate clinical evidence on the benefits of
meningococcal immunisation. The trial started in August 2020, and
approximately 3,650 participants aged 10-25 were enrolled in the US, Canada,
Czech Republic, Estonia, Finland, Turkey, and Australia.
The objective of the trial was to assess the safety profile of the MenABCWY
vaccine candidate, to assess the immunological vaccine effectiveness against a
panel of 110 MenB strains, and to compare the immune responses of the trial's
participants who received two doses of the MenABCWY vaccine candidate six
months apart to the responses of those in the control groups who received
GSK's licensed vaccines, Bexsero (MenB) and one dose of Menveo (MenACWY).
There are a total of 11 primary endpoints for the trial, five for MenABCWY and
six for Bexsero. Bexsero is used as the comparator for the MenB immune
responses induced by the MenABCWY vaccine in the trial, which is both the
phase III trial for MenABCWY and confirmatory trial for Bexsero in the US.
About Bexsero
Bexsero is currently licensed or has received regulatory approval in over 50
countries, including the US and EU, and is used in 13 national immunisation
programmes worldwide for the prevention of IMD caused by Neisseria
meningitidis serogroup B. Bexsero is the only MenB vaccine with trials that
have demonstrated a reduction in IMD, including vaccine effectiveness in
real-world settings. Regulatory approvals vary by country. It is approved for
individuals two months of age and older in Europe.
In the US, Bexsero is licensed under the Accelerated Approval pathway for
active immunisation to prevent IMD caused by Neisseria meningitidis serogroup
B in individuals from 10 through 25 years. Approval of Bexsero is based on
demonstrating an immune response, as measured by serum bactericidal activity
against three serogroup B strains representative of prevalent strains in the
US. The effectiveness of Bexsero against diverse serogroup B strains has not
been confirmed.
Please see the US Prescribing Information:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF
About Menveo
Menveo vaccine for meningococcal groups A, C, Y, and W has received regulatory
approval in over 60 countries, including the US, with more than 72 million
doses distributed worldwide since 2010. Menveo offers extensive evidence of
immunogenicity with a well-characterised safety profile.
In the US, Menveo has received regulatory approval for active immunisation to
prevent IMD caused by Neisseria meningitidis serogroups A, C, Y, and W in
individuals from 2 months through 55 years of age. However, Menveo does not
prevent N. meningitidis serogroup B infections.
Please see the US Prescribing Information:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF
About Invasive meningococcal disease
Invasive meningococcal disease (IMD), a major cause of meningitis and
septicaemia, is an uncommon but serious illness that can cause
life-threatening complications or even death. 6 (#_edn6) Among those
contracting meningococcal diseases, one in ten will die, sometimes in as
little as 24 hours, despite treatment. 7 (#_edn7) One-in-five survivors
suffer long-term consequences, such as brain damage, amputations, hearing loss
and nervous system problems.6
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:
https://www.gsk.com/en-gb/company/
GSK enquiries
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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,
and Q1 Results for 2023 and any impacts of the COVID-19 pandemic.
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References
(#_ednref1) 1. Muzzi A, Bodini M, Topaz N, et al. Genetic Features of a
Representative Panel of 110 Meningococcal B Isolates to Assess the Efficacy of
Meningococcal B Vaccines. mSphere. 2022;7(5): e0038522. doi:10.1128/msphere.
00385-22.
2 (#_ednref2) . CDC. Meningococcal Disease and How It Spreads. Available at:
https://www.cdc.gov/meningococcal/about/causes-transmission.html
(https://www.cdc.gov/meningococcal/about/causes-transmission.html) . Accessed
May 2023.
3 (#_ednref3)
. CDC. University-Based Outbreaks of Meningococcal Disease Caused by Serogroup B, United States, 2013-2018
Available at: https://wwwnc.cdc.gov/eid/article/25/3/18-1574_article#r1
(https://wwwnc.cdc.gov/eid/article/25/3/18-1574_article#r1) . Accessed May
2023.
4 (#_ednref4) . MacNeil JR, Blain AE, Wang X, Cohn AC. Current
epidemiology and trends in meningococcal disease-United States,
1996-2015. Clin Infect Dis. 2018; 66:1276-81.
5 (#_ednref5) . Pingali C, Yankey D, Elam-Evans LD, et al. National
Vaccination Coverage Among Adolescents Aged 13-17 Years - National
Immunization Survey-Teen, United States, 2021. MMWR Morb Mortal Wkly Rep 2022;
71:1101-1108.
6 (#_ednref6) . ECDC, Facsheet about meningococcal disease. Available at:
https://www.ecdc.europa.eu/en/meningococcal-disease/factsheet.eu
(https://www.ecdc.europa.eu/en/meningococcal-disease/factsheet.eu)) ..
Accessed May 2023.
7 (#_ednref7) . Bing Wang et al., "Case fatality rates of invasive
meningococcal disease by serogroup and age: A systematic review and
meta-analysis", in Vaccine, Volume 37, Issue 21, 9 May 2019, Pages 2768-2782.
Accessed May 2023.
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