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 January 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: 28 January 2025 London UK
Depemokimab accepted for review by the European Medicines Agency
for use in asthma with type 2 inflammation and CRSwNP
● If
approved, depemokimab will be the first ultra-long-acting biologic
with 6-month dosing
● Submissions
based on data from positive SWIFT and ANCHOR
trials
● SWIFT-1
and -2 showed depemokimab reduced exacerbation and hospitalisation
rates as an add-on therapy for patients with asthma with type 2
inflammation
● ANCHOR-1
and -2 showed depemokimab reduced nasal polyp size and obstruction
compared to placebo
GSK plc (LSE/NYSE: GSK) today announced that the
European Medicines Agency has accepted for
review
the Marketing
Authorisation Application for
the use of depemokimab in two
indications.
The submitted indications are for add-on maintenance treatment of
asthma in adult and adolescent patients aged 12 years and older
with type 2 inflammation characterised by an eosinophilic phenotype
who are inadequately controlled on medium to high dose
corticosteroids (ICS) plus another asthma controller and also as an
add-on treatment in adult patients with inadequately controlled
chronic rhinosinusitis with nasal polyps (CRSwNP).
Kaivan Khavandi,
SVP, Global Head of Respiratory/Immunology
R&D, said "Simultaneous
regulatory submissions for two indications highlight our confidence
in depemokimab to help reduce the burden of both asthma and CRSwNP
for patients and health systems. Our SWIFT and ANCHOR trials
support depemokimab's potential to suppress IL-5, a known driver of
type 2 inflammation, to offer patients sustained inhibition of a
key driver of their disease with just two doses per
year."
Depemokimab, a monoclonal antibody that targets interleukin-5
(IL-5), is the first ultra-long-acting biologic to be evaluated in
phase III trials and be accepted for regulatory review for use in
these conditions.1 Depemokimab's
extended half-life, high-binding affinity and potency, support six
month (26 week) dosing regimens based on results from the
SWIFT and ANCHOR trials.1-3 In
asthma patients and patients with CRSwNP, these trials showed
depemokimab could offer sustained inhibition of a key driver
of their disease, and help achieve key clinical outcomes with
a dosing schedule of just two injections per
year.1-3 Longer
intervals between doses have been shown to overcome barriers to
optimal care such as patient adherence.4
IL-5 is a key cytokine (protein) in type 2
inflammation.1,5,6 Type
2 inflammation is typically identified by blood eosinophil count
and is an underlying driver in many diseases. This type of
inflammation is present in the majority of patients with difficult
to treat asthma and can lead to exacerbations and
hospitalisation.5-7.
Type 2 inflammation is also present in up to 80% of people with
CRSwNP and is associated with more severe disease and
symptoms.8-12
In Europe, more than 42 million people are estimated to have
asthma, which contributes to the significant burden this condition
has on the lives of patients and healthcare resources, with an
estimated annual societal cost of 46 billion
euros.13 CRSwNP
is a chronic condition that affects up to 4% of the general
population, of whom 40% have uncontrolled
disease.8,9,12
Depemokimab is currently not approved in any country.
About the depemokimab development programme
The phase III asthma programme consists of SWIFT-1 and
SWIFT-2 in asthma with type 2 inflammation, with an open
label extension study (AGILE).1,14 An
additional study (NIMBLE) is underway to assess the efficacy and
safety of depemokimab when participants with asthma with type 2
inflammation are switched from mepolizumab or
benralizumab.15
The phase III programme in CRSwNP includes two studies, ANCHOR-1
and ANCHOR-2.2,3
Depemokimab is currently being evaluated in phase III trials for
the treatment of other IL-5 mediated
diseases, including OCEAN for eosinophilic granulomatosis with
polyangiitis (EGPA)16 and
DESTINY for hypereosinophilic syndrome (HES).17
About SWIFT-1 and SWIFT-2
SWIFT-1 and SWIFT-2 were replicate 52-week, randomised (2:1),
double-blind, placebo-controlled, parallel-group, multi-centre
Phase III clinical trials.1 The
trials assessed the efficacy and safety of depemokimab adjunctive
therapy in 382 and 380 adult
and adolescent participants
with asthma with type
2 inflammation characterised by blood eosinophil
count, who
were randomised to receive depemokimab or placebo respectively, in
addition to their standard of care treatment with medium to
high-dose inhaled corticosteroids plus at least one additional
controller.1 Number
of subjects included in the Full Analysis of SWIFT-1: depemokimab =
250, placebo = 132 and in SWIFT-2: depemokimab = 252, placebo =
128.1
These results have
been reported and published in the https://www.nejm.org/stoken/default+domain/REPRINTS_36509/full?redirectUri=/doi/full/10.1056/NEJMoa2406673
About ANCHOR-1 and ANCHOR-2
ANCHOR-1 and ANCHOR-2 were replicate phase III clinical
trials with
the same primary and secondary endpoints assessing
the safety and efficacy of depemokimab as add-on therapy in adult
patients with CRSwNP. Both were 52-week, randomised (1:1),
double-blind, parallel group, placebo-controlled, multi-centre
trials. 2,3 Number
of subjects included in the Full Analysis Set of ANCHOR-1:
depemokimab = 143, placebo = 128 and in ANCHOR-2: depemokimab =
129, placebo = 128.
Both studies met their co-primary endpoints of change from baseline
in total endoscopic nasal polyp score at 52 weeks and change from
baseline in nasal obstruction verbal response scale (VRS) mean
score from weeks 49 to 52. The overall incidence and severity of
treatment-emergent adverse events across ANCHOR-1 and ANCHOR-2 were
also similar in patients treated with either depemokimab or
placebo.
Full results of ANCHOR-1 and ANCHOR-2 will be presented at an
upcoming scientific congress.
About Asthma, CRSwNP and type 2 inflammation.
Asthma affects more than 260 million people
globally many
of whom continue to experience symptoms and exacerbations despite
treatment with high-dose inhaled corticosteroids plus a second
controller (and/or systemic corticosteroids).4,17 Asthma
presents a significant financial burden to patients as
exacerbations place a resource burden on healthcare systems due to
emergency department visits and
hospitalisations.18-20
CRSwNP is caused by inflammation of the nasal lining that can lead
to soft tissue growths, known as nasal polyps.9,12 People
with CRSwNP experience
symptoms such as nasal obstruction, loss
of smell, facial pain, sleep disturbance, infections and nasal
discharge that can
significantly affect their emotional and physical
well-being.9,12
There is evidence to show IL-5 has broad effects on other
structural and immune and cell types beyond eosinophils, and how
they contribute to inflammation, which can lead to lung remodelling
and disease progression.5,6,21-25 Ongoing
research is generating further evidence to understand the roles of
these cells and their potential contribution to clinical outcomes
in patients with respiratory diseases. Type 2 inflammation drives
the underlying dysfunction of various immune-mediated conditions.
IL-5 is a core cytokine (protein) in type 2
inflammation.5,6
The presence of type 2 inflammation in asthma or CRSwNP can be
detected by blood eosinophil count, which measures the level of a
type of white blood cell.5,8,12
About GSK in respiratory
GSK is
redefining the future of respiratory medicine as it builds on
decades of pioneering work to deliver more ambitious treatment
goals and develop the next-generation standard of care, 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 diseases like refractory
chronic cough or rarer conditions like systemic sclerosis with
interstitial lung disease. GSK is harnessing the latest science and
technology with the aim to modify underlying disease dysfunction
and prevent disease 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 under Item 3.D
"Risk factors" in GSK's Annual Report on Form 20-F for 2023, and
GSK's Q3 Results for 2024.
Registered in England & Wales:
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1DG
References
1. Jackson
DJ, et al. Six Monthly Depemokimab in Severe Asthma With an
Eosinophilic Phenotype. NEJM. Published on September 9
at NEJM.org.
2. ClinicalTrials.gov. Efficacy
and Safety of Depemokimab (GSK3511294) in Participants With Chronic
Rhinosinusitis With Nasal Polyps (ANCHOR-1) Available
at: https://clinicaltrials.gov/study/NCT05274750 Accessed
January 2025.
3. ClinicalTrials.gov. Efficacy
and Safety of Depemokimab (GSK3511294) in Participants With Chronic
Rhinosinusitis With Nasal Polyps (ANCHOR-2) Available
at: https://clinicaltrials.gov/study/NCT05281523
Accessed January 2025.
4. Scarsi
KK, Swindells S. The Promise of Improved Adherence With Long-Acting
Antiretroviral Therapy: What Are the Data? Journal of
the International Association of Providers of AIDS Care
(JIAPAC).
2021;20.
5. Global
Initiative for Asthma. Global Strategy for Asthma Management and
Prevention,2024. Updated May 2024. Available at: https://ginasthma.org/.
Accessed January
2025.
6.
Heaney L, et al. Eosinophilic
and Noneosinophilic Asthma: An Expert Consensus Framework to
Characterize Phenotypes in a Global Real-Life Severe Asthma
Cohort. Chest.
2021;160(3):814-830.
7. Principe
S, et
al. Severe
asthma: Targeting the IL-5 pathway. Clin
Exp Allergy. 2021
Aug;51(8):992-1005
8. Laidlaw
TM, et al. Chronic Rhinosinusitis with Nasal Polyps and
Asthma. J. Allergy
Clin. Immunol.
2001;9(3):1133-1141.
9. Bachert
C, et al. Burden of Disease in Chronic Rhinosinusitis with Nasal
Polyps. J
Asthma Allergy.
2021;b 11;14:127-134. doi: 10.2147/JAA.S290424. PMID: 33603409;
PMCID: PMC7886239.
10. De
Corso E, et al. How
to manage recurrences after surgery in CRSwNP patients in the
biologic era: a narrative review. Acta
Otorhinolaryngol Ital. 2023;43(Suppl.
1):S3-S13.
11. Chen
S, et al. Systematic literature review of the epidemiology and
clinical burden of chronic rhinosinusitis with nasal
polyposis. Curr
Med Res Opin.
2020;36(11):1897-1911.
12. Bachert
C, et al. EUFOREA expert board meeting on uncontrolled severe
chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics:
Definitions and management. J
Allergy Clin Immunol.
2021;147(1):29-36.
13.
International Respiratory Coalition. Asthma. Available
at: https://international-respiratory-coalition.org/diseases/asthma/ Accessed
January 2025
14. ClinicalTrials.gov. An
Open-Label Extension Study of GSK3511294 (Depemokimab) in
Participants Who Were Previously Enrolled in 206713 (NCT04719832)
or 213744 (NCT04718103) (AGILE). Available at: https://clinicaltrials.gov/study/NCT05243680 Accessed
January 2025.
15. ClinicalTrials.gov. A
Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or
Benralizumab in Participants With Severe Asthma With an
Eosinophilic Phenotype (NIMBLE). Available at: https://clinicaltrials.gov/study/NCT04718389 Accessed
January 2025.
16. ClinicalTrials.gov. Efficacy and
Safety of Depemokimab Compared With Mepolizumab in Adults With
Relapsing or Refractory Eosinophilic Granulomatosis With
Polyangiitis (EGPA) Available at: https://clinicaltrials.gov/study/NCT05263934 Accessed
January 2025.
17. ClinicalTrials.gov. Depemokimab
in Participants With Hypereosinophilic Syndrome, Efficacy, and
Safety Trial (DESTINY) Available
at: https://clinicaltrials.gov/study/NCT05334368 Accessed
January 2025.
18. Israel,
E, et
al. Severe and
Difficult-to-Treat Asthma in Adults. N Engl J Med
2017;377:965-76.
19. World
Health Organisation. Asthma Key Facts. Available
at https://www.who.int/news-room/fact-sheets/detail/asthma Accessed
January 2025
20. European
Federation of Allergy and Airways Disease Patients' Association.
Available at: Severely,
Asthma! project - European Federation of Allergy and Airways
Diseases Patients' Associations (EFA) Accessed
January 2025
21. Buchheit
KM, et al. Mepolizumab targets multiple immune cells in
aspirin-exacerbated respiratory disease. J
Allergy Clin Immunol.
2021;148(2):574-584.
22. Barretto
KT, et al. Human airway epithelial cells express a functional IL-5
receptor. Allergy.
2020;75(8):2127-2130.
23. Bajbouj
K, et al. IL-5 receptor expression in lung fibroblasts: Potential
role in airway remodelling in asthma. Allergy.
2023;78(3):882-885.
24. Siddiqui
S, et al. Eosinophils and tissue remodeling: Relevance to airway
disease. J
Allergy Clin Immunol.
2023;152(4):841-857.
25. Bergantini
L, et al. Regulatory T cell monitoring in severe eosinophilic
asthma patients treated with mepolizumab. Scand
J Immunol.
2021;94(1):e13031.
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: January
28, 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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