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 March 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: 3 March 2025, London UK
Depemokimab applications accepted for review by the US
FDA for
asthma with type 2 inflammation and for chronic
rhinosinusitis with nasal polyps (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 versus placebo
● ANCHOR-1
and -2 showed early and sustained reductions in nasal polyp size
and nasal obstruction versus placebo
GSK plc (LSE/NYSE: GSK) today
announced the US Food and Drug Administration (FDA) has accepted
for review the Biologics
License Application for
the use of depemokimab
in two indications.
The proposed indications are as add-on maintenance treatment of
asthma in adult and pediatric patients aged 12 years and older with
type 2 inflammation characterised by an eosinophilic phenotype on
medium- to high-dose inhaled corticosteroids (ICS) plus another
asthma controller and, as add-on maintenance treatment in adult
patients with inadequately controlled chronic rhinosinusitis with
nasal polyps (CRSwNP).
The Prescription Drug User Fee Act (PDUFA) date is 16 December
2025.
Kaivan Khavandi,
SVP and Global
Head, Respiratory, Immunology & Inflammation R&D,
GSK, 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 interleukin-5 (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 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.1-3 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
patients with asthma with type 2 inflammation and patients with
CRSwNP, these trials met their primary endpoints, showing that
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 As
demonstrated in studies of other diseases, 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 85% of people with CRSwNP
and is associated with more severe disease and
symptoms.8-12
In the United States, more than 26 million people are currently
affected by asthma, 40% of whom report having had at least one
asthma attack in the previous year which contributes to significant
burden this condition exerts on healthcare resources and the lives
of patients.13,14 Each
year asthma leads to an estimated 100,000 hospitalisations and
nearly 1 million emergency department visits and we are
determined to help reduce the burden that respiratory diseases like
asthma and CRSwNP exert on patients and healthcare
systems.14
In the United States, 2.1% of the population are affected by
chronic rhinosinusitis, up to 30% of whom have nasal
polyps.8 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.8-11 Such
symptoms mean the impact of CRSwNP on overall quality of life
has been reported to be comparable with other chronic diseases such
as COPD, asthma, and diabetes.9
Depemokimab is currently not approved for use 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).1,15 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.16
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)17 and
DESTINY for hypereosinophilic syndrome (HES).18
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 as
adjunctive therapy in 382 and 380 participants with
severe asthma with type
2 inflammation characterised by blood eosinophil count,
including adult
and adolescent patients,
who were randomised to receive depemokimab or a 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 New
England Journal of Medicine.1
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. 2,3 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 were presented on Saturday 1
March at the 2025
American Academy of Allergy, Asthma and Immunology (AAAAI) and
World Allergy Organization (WAO) Joint Congress in San Diego and
simultaneously published in The
Lancet.19
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).5,20 Asthma
presents a significant financial burden to patients as
exacerbations place a resource burden on healthcare systems due to
emergency department visits and
hospitalisations.5,21
CRSwNP is caused by inflammation of the nasal lining that can lead
to soft tissue growths, known as nasal polyps.8,9 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.8-11
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.5,6,22-26 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.4,5 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.5,10
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 Annual Report for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
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 February 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 February 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 February 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.
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.
American Lung Association. Severe Asthma. Available
at: https://www.lung.org/lung-health-diseases/lung-disease-lookup/asthma/learn-about-asthma/types/severe-asthma.
Accessed February 2025.
14.
American Lung Association. Asthma Trends and Burden. Available
at: https://www.lung.org/research/trends-in-lung-disease/asthma-trends-brief/trends-and-burden.
Accessed February 2025.
15.
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
February 2025.
16.
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
February 2025.
17.
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
February 2025.
18.
ClinicalTrials.gov. Depemokimab in Participants With
Hypereosinophilic Syndrome, Efficacy, and Safety Trial (DESTINY)
Available at: https://clinicaltrials.gov/study/NCT05334368.
Accessed February 2025.
19.
Gevaert P, et al.
Efficacy and safety of twice per year depemokimab in chronic
rhinosinusitis with nasal
polyps (ANCHOR-1 and ANCHOR-2): phase III, randomised,
double-blind, parallel trials. The
Lancet.
Published on February 28 at thelancet.com.
20.
World Health Organisation. Asthma Key Facts. Available
at: https://www.who.int/news-room/fact-sheets/detail/asthma. Accessed
February 2025
21.
Israel, E, et al. Severe and Difficult-to-Treat Asthma in
Adults. N Engl J Med 2017;377:965-76.
22.
Buchheit KM, et al. Mepolizumab targets multiple immune cells in
aspirin-exacerbated respiratory disease. J Allergy Clin Immunol.
2021;148(2):574-584.
23.
Barretto KT, et al. Human airway epithelial cells express a
functional IL-5 receptor. Allergy.
2020;75(8):2127-2130.
24.
Bajbouj K, et al. IL-5 receptor expression in lung fibroblasts:
Potential role in airway remodelling in asthma. Allergy.
2023;78(3):882-885.
25.
Siddiqui S, et al. Eosinophils and tissue remodeling: Relevance to
airway disease. J Allergy Clin Immunol.
2023;152(4):841-857.
26.
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: March
03, 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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