UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of May 2025
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued: 30 April 2025, London UK
Nucala (mepolizumab) delivers
clinically meaningful and statistically significant reduction in
COPD exacerbations, with positive MATINEE trial results published
in New
England Journal of Medicine
●
21%
reduction in annualised rate of moderate/severe exacerbations in a
wide COPD population
● 31% reduction in annualised rate
of moderate/severe exacerbations in the sub-group of patients with
chronic bronchitis only in post-hoc analysis
● 35% reduction in annualised rate of exacerbations
leading to emergency department visit and/or hospitalisation
secondary endpoint*
GSK plc (LSE/NYSE: GSK) today announced positive results
for Nucala (mepolizumab)
in the treatment of chronic obstructive pulmonary disease (COPD),
with the full results from the MATINEE phase III trial published in
the New England
Journal of Medicine. The
trial evaluated mepolizumab, a monoclonal
antibody targeting
interleukin-5 (IL-5), in a
wide spectrum of patients with COPD, including the most severe and
difficult to treat as categorised in the Global Initiative for
Chronic Obstructive Lung Disease (GOLD)
guidelines.1 Patients
recruited had evidence of type 2 inflammation, characterised
by blood eosinophil count, and included those with chronic
bronchitis, emphysema-only or both.2 The
monthly administration of mepolizumab demonstrated improvement
across all exacerbation endpoints, which were maintained over the
2-year (up to 104 weeks) study period.2
In the full population studied, mepolizumab showed a clinically
meaningful and statistically significant 21% reduction in the
annualised rate of moderate/severe exacerbations versus
placebo, meeting the primary endpoint for MATINEE (rate ratio [95%
confidence interval (CI)]: 0.79 [0.66, 0.94]; P=0.011) (AER
mepolizumab = 0.80 exacerbations per year versus placebo = 1.01) n=
804; mepolizumab = 403,
placebo = 401).2 In
addition, mepolizumab also showed a 31% reduction in the annualised
rate of moderate/severe exacerbations versus placebo in a post-hoc
analysis of patients with clinician assessed chronic bronchitis
only (rate ratio [95% CI]: 0.69 [0.51, 0.93] n=338: mepolizumab =
170, placebo = 168).2
A 35% reduction in the annualised rate of exacerbations leading to
emergency department visits and/or hospitalisation was shown with
mepolizumab versus placebo, a secondary endpoint of the MATINEE
study (rate ratio [95% CI]: 0.65 [0.43, 0.96] nominally significant
after adjustment for multiplicity) (AER mepolizumab = 0.13
exacerbations per year versus placebo = 0.20)). Mepolizumab is the
only biologic with data that shows a reduction in emergency
department visits and/or hospitalisation in a phase III trial.
Reducing hospitalisations is a key goal of COPD
management.3 COPD-related
hospitalisations are a major healthcare challenge and projected to
become the number one cause of medical
admissions.4 If
hospitalised due to COPD, one in ten patients will die during the
stay, up to one in four over the next year and half will lose their
lives within five years.5,6
Kaivan Khavandi, SVP, Global
Head, Respiratory, Immunology & Inflammation R&D,
GSK said: "Today's
MATINEE results show that mepolizumab can help prevent
exacerbations, including those leading to emergency department
visits and/or hospitalisation. These exacerbations are devastating
for patients, known to cause irreversible lung damage, worsening of
symptoms and increased mortality. For decades, we have and will
continue to push the boundaries of innovation to prevent disease
progression and make a meaningful impact on the lives of people
affected by COPD."
Frank Sciurba, Professor of Pulmonary, Allergy and Critical Care
Medicine, and lead author of the MATINEE trial
said: "Every
physician will know the feeling of seeing a patient hospitalised
due to an exacerbation that could have possibly been prevented. The
MATINEE trial uncovers
new possibilities in the treatment landscape for COPD
patients with type 2 inflammation, as we strive to target drivers
of disease and improve the lives of patients suffering with
COPD."
High response rates were observed in Patient Reported Outcomes
(PROs) in the mepolizumab group, however there was no difference
observed for St George's Respiratory Questionnaire (SGRQ), the COPD
Assessment Test (CAT) and the Evaluating Respiratory Symptoms
(E-RS) in the full study population versus
placebo.2 The
incidence of adverse events were similar between mepolizumab and
placebo (mepolizumab vs placebo: 74% vs 77%), with the most
frequent being exacerbation or worsening of COPD (mepolizumab vs
placebo: 12% vs 15%) and COVID-19 infection (12% vs
12%).2
Nucala is
not approved for the treatment of COPD in any country. Regulatory
submissions are under review in several countries, including the
US, China and the EU. The US FDA has provided a PDUFA date of May
7, 2025.
*Nominally significant after adjustment for
multiplicity
About MATINEE
MATINEE is a phase III, randomised (1:1), double-blind,
parallel-group trial assessing the efficacy and safety of
mepolizumab 100 mg as add-on therapy, administered subcutaneously
every 4 weeks for 52-104 weeks, versus placebo in addition to
optimal inhaled triple therapy (dual long-acting bronchodilators
plus inhaled corticosteroid).2
Positive results were achieved in a wide population of patients
with COPD. The efficacy and safety of mepolizumab was assessed in
patients with COPD with evidence of type 2 inflammation,
characterised by a blood eosinophil count (≥300
cells/µL). Patients could participate with a range of clinical
presentations of COPD including chronic bronchitis, emphysema only
or a combination of both. The condition of patients ranged in
severity from moderate to very severe, or stages 2-4 as assessed by
the medically recognised scale of Global Initiative for Chronic
Obstructive Lung Disease (GOLD).2 The
full analysis of MATINEE included 403 patients enrolled on the
mepolizumab arm and 401 on placebo, all of whom had
experienced exacerbations in the previous year despite receiving
optimised inhaled maintenance therapy.2
About chronic obstructive pulmonary disease (COPD) and type 2
inflammation
COPD is a progressive and heterogeneous inflammatory lung disease
that includes chronic bronchitis and/or
emphysema.3 It
affects more than 390 million people globally and is the third
leading cause of death.7,8 Patients
with COPD experience persistent respiratory symptoms such as
breathlessness, cough, and sputum along with progressive airflow
obstruction due to the chronic inflammation, that impact daily
life.3 Type
2 inflammation is present in a variety of immuno-inflammatory
conditions and is a major contributor to symptoms and exacerbations
in up to 40% of people with COPD.2,9
Despite inhaled triple therapy, many patients experience persistent
symptoms and exacerbations.10 Exacerbations
are acute episodes of worsening COPD symptoms, which can result in
hospitalisation and irreversible lung damage.3 Early
intervention is important in preventing exacerbations and
cumulative lung damage.3
About Nucala
Nucala is
a monoclonal antibody that targets and binds to interleukin-5
(IL-5), a key messenger protein (cytokine) in type 2
inflammation. Nucala has
been developed for the treatment of a range of IL-5 mediated
diseases associated with type 2 inflammation. It is currently
approved for use in the US and Europe across four IL-5 mediated
conditions. Nucala is
currently not indicated for COPD in any
country.
For product and important safety information please consult the
country relevant summary of product characteristics.
EU available at: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf. The
US prescribing information is available at: NUCALA-PI-PIL-IFU-COMBINED.PDF.
About GSK in respiratory
GSK continues to build on decades of pioneering work to deliver
more ambitious treatment goals, develop the next generation
standard of care, and redefine the future of respiratory medicine
for hundreds of millions of people with respiratory diseases. With
an industry-leading respiratory portfolio and pipeline of vaccines,
targeted biologics and inhaled medicines, we are focused on
improving outcomes and the lives of people living with all types of
asthma and COPD along with less understood refractory chronic cough
or rarer conditions like systemic sclerosis with interstitial lung
disease. GSK is harnessing the latest science and technology with
the aim of modifying the underlying disease dysfunction and
preventing progression.
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 in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q1 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References:
1. Hoffman
M. Lung Disease & Respiratory Health. COPD Stages and the GOLD
Criteria. WebMD. Available at: https://www.webmd.com/lung/copd/gold-criteria-for-copd.
14 May 2023. Last accessed April 2025.
2. Sciurba
F, et al. Mepolizumab to prevent exacerbations in COPD with an
eosinophilic phenotype. NEJM Published 1 May issue. Available
at https://www.nejm.org/stoken/default+domain/REPRINTS_36868_2/full?redirectUri=/doi/full/10.1056/NEJMoa2413181
3. Global
Initiative for Chronic Obstructive Lung Disease. 2025 Gold Report.
Available at: https://goldcopd.org/ Last
accessed April 2025.
4. Khakban
A, et al. The Projected Epidemic of Chronic Obstructive Pulmonary
Disease Hospitalizations over the Next 15 Years. A Population-based
Perspective. Am
J Respir Crit Care Med.
2017;195(3):287-291. https://www.atsjournals.org/doi/10.1164/rccm.201606-1162PP Waeijen-Smit
K, et al. Global
mortality and readmission rates following COPD exacerbation-related
hospitalisation: a meta-analysis of 65 945 individual
patients. ERJ
Open Res. 2024
Feb 26;10(1):00838-2023. doi: https://publications.ersnet.org/content/erjor/10/1/00838-2023
5. van
Hirtum PV, et al. Long
term survival after admission for COPD exacerbation: A comparison
with the general population. Respir
Med. 2018;137:77-82.
doi: https://www.resmedjournal.com/article/S0954-6111(18)30052-0/fulltext
6. Adeloye
D, et al. Global, regional, and national prevalence of, and risk
factors for, chronic obstructive pulmonary disease (COPD) in 2019:
a systematic review and modelling
analysis. Lancet
Respir Med. 2022;10(5):447-458.
doi: https://pmc.ncbi.nlm.nih.gov/articles/PMC9050565/
7. Chen S, et
al. The global economic burden of chronic obstructive pulmonary
disease for 204 countries and territories in 2020-50: a
health-augmented macroeconomic modelling
study. Lancet Glob
Health. 2023;11(8):e1183-e1193.
doi: https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(23)00217-6/fulltext
8. Rabe
KF, et al. Targeting Type
2 Inflammation and Epithelial Alarmins in Chronic Obstructive
Pulmonary Disease: A Biologics Outlook. Am J Respir
Crit Care Med.
2023;208(4):395-405. doi: https://www.atsjournals.org/doi/10.1164/rccm.202303-0455CI
9. Chen
S, Miravitlles M, Rhee CK, et al. Patients with Chronic Obstructive
Pulmonary Disease and Evidence of Eosinophilic Inflammation
Experience Exacerbations Despite Receiving Maximal Inhaled
Maintenance Therapy. Int J Chron
Obstruct Pulmon Dis. 2022 Sep 9;17:2187-2200.
doi: https://www.dovepress.com/patients-with-chronic-obstructive-pulmonary-disease-and-evidence-of-eo-peer-reviewed-fulltext-article-COPD
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: May
01, 2025
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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