REG - GSK PLC - Positive phase III results for MenABCWY vaccine

GSKAnnouncement

14/03/2023 07:15

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RNS Number : 8287S  GSK PLC  14 March 2023

Issued: 14 March 2023, London UK

 

 

GSK announces positive pivotal phase III data for 5-in-1 Meningococcal ABCWY
vaccine candidate

 

·   MenABCWY combination vaccine candidate met all 11 primary endpoints of
the pivotal phase III clinical trial and was well tolerated with a safety
profile consistent with Bexsero and Menveo

·   The primary endpoint data demonstrated statistical non-inferiority
compared to Bexsero and Menveo in individuals 10-25 years old, with the 5-in-1
vaccine candidate eliciting a clinically meaningful immune response

·   If approved, this 5-in-1 vaccine candidate could provide the broadest
meningococcal serogroup coverage and could lead to a simplified immunisation
schedule

 

GSK plc (LSE/NYSE: GSK) today announced positive headline results from the
phase III trial (NCT04502693 (https://clinicaltrials.gov/ct2/show/NCT04502693)
) evaluating the safety, tolerability, and immunogenicity of its MenABCWY
combination vaccine candidate, administered as two doses given six months
apart in healthy individuals aged 10-25 years. GSK's MenABCWY vaccine
candidate combines the antigenic components of its licensed meningococcal
vaccines, Bexsero (MenB) and Menveo (MenACWY). All primary endpoints were met,
including the non-inferiority of the vaccine candidate for all five Neisseria
meningitides serogroups (A, B, C, W, and Y) compared to licensed meningococcal
vaccines Bexsero and Menveo in terms of an immune response. In addition, the
vaccine candidate was well tolerated, with a safety profile consistent with
Bexsero and Menveo.

 

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, typically amongst previously
healthy children and adolescents.(1) Among those contracting meningococcal
diseases, one in ten will die, sometimes in as little as 24 hours, despite
treatment.(2) One-in-five survivors suffers long-term consequences, such as
brain damage, amputations, hearing loss and nervous system problems.(1)

 

Five Neisseria meningitides serogroups (A, B, C, W, and Y) account for nearly
all IMD cases in most of the world.(3) As yet, no licensed combination vaccine
offers protection against these serogroups in a single vaccine. Currently, in
the US, two separate vaccines needing four injections are required to protect
against all five serogroups. This immunisation regimen, coupled with low
awareness of the disease, can lead to sub-optimal immunisation coverage rates,
particularly for MenB, with an estimated coverage of only approximately 31% of
adolescents in the US.(4)

 

Tony Wood, Chief Scientific Officer at GSK, said: "These statistically
significant phase III data are a very encouraging step toward reducing the
incidence of meningococcal disease. In the US, routine use of a 5-in-1
meningococcal vaccine with a two-dose regimen in adolescents at 16 to 18 years
of age, just before this disease's incidence peak, could drive significant
public health impact. In addition, our 5-in-1 meningococcal vaccine candidate
builds on our global leadership in meningococcal vaccines and commitment to
innovation."

 

GSK is working closely with regulators to review the full phase III data set,
including the supplemental Biologics License Application for Bexsero. This
clinical trial was both the confirmatory trial for Bexsero and the phase III
trial for MenABCWY. Detailed results from this phase III trial will be
presented in a peer-reviewed publication and at upcoming scientific meetings.

 

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,
(https://www.gsk.com/en-gb/media/press-releases/gsk-announces-first-participant-vaccinated-in-phase-3-clinical-trials-of-its-5-in-1-meningitis-abcwy-vaccine-candidate/)
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 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 Menveo (MenACWY).

About Bexsero

Bexsero is currently licensed or has received regulatory approval in over 50
countries, including the US and EU, and is used in 12 national immunisation
programmes worldwide for the prevention of IMD caused by Neisseria
meningitides 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 meningitides 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. The US Prescribing Information is available here.
(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 (consistent with
similar vaccines).

In the US, Menveo has received regulatory approval for active immunisation to
prevent IMD caused by Neisseria meningitides serogroups A, C, Y, and W in
individuals from 2 months through 55 years of age. However, Menveo does not
prevent N. meningitides serogroup B infections. The US Prescribing Information
is available here.
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF)

 

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 Q4 Results for 2022 and any impacts of the COVID-19 pandemic.

 

 

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References

1 ECDC, Factsheet about meningococcal diseases
(https://www.ecdc.europa.eu/en/meningococcal-disease/factsheet) . Accessed
March 2023.

2. 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 March 2023.

3 CDC. Meningococcal Disease Causes and How It Spreads | CDC
(https://www.cdc.gov/meningococcal/about/causes-transmission.html) . Accessed
March 2023.

4 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.

 

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