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: 1 March 2025, London
UK
Depemokimab delivers clinically meaningful and statistically
significant improvements for patients with chronic rhinosinusitis
with nasal polyps (CRSwNP)
● ANCHOR-1
and ANCHOR-2 phase III trials show improvements in nasal polyp size
and obstruction for depemokimab with twice-yearly dosing versus
placebo
● Results
with depemokimab were observed early at first assessment and
sustained over 52 weeks
● Late-breaking
data presented at the 2025 American Academy of Allergy, Asthma and
Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress
and simultaneously published in The
Lancet
GSK plc (LSE/NYSE: GSK) today announced full results from the
positive ANCHOR-1 and ANCHOR-2 phase III clinical trials assessing
the efficacy and safety of depemokimab versus placebo (both with
standard of care [SOC]) in adults with CRSwNP. Depemokimab is an
investigational, ultra-long-acting monoclonal antibody
targeting interleukin-5
(IL-5), a key
cytokine (protein) in type 2 inflammation that presents in up to
85% of people with CRSwNP.1-5 Results
from these studies were presented in a late-breaking oral abstract
session at the 2025 AAAAI/WAO Joint Congress in San Diego,
California and simultaneously published in The
Lancet.
ANCHOR-1 (N=271) and ANCHOR-2 (N=257) met their co-primary
endpoints, with twice-yearly administration of depemokimab showing
clinically meaningful and statistically significant improvements in
nasal polyp size and nasal obstruction, two key clinical measures
of disease severity, versus placebo.6,7 Additionally,
a pooled analysis of the two trials showed improvements
(reductions) from baseline versus placebo measured
by:
●
Nasal
polyp score (NPS, 0-8) at 52 weeks (treatment difference [95% CI],
-0.7 [-0.9, -0.4], nominal p<0.001).
●
Mean
nasal obstruction scores (verbal response scale [VRS, 0-3]) over
weeks 49-52 (treatment difference [95% CI], -0.24 [-0.39, -0.08],
nominal p=0.003).
ANCHOR-1 and ANCHOR-2 recruited a broad patient population with
heterogenous symptom severity, reflective of real-world clinical
practice. The treatment benefits were observed by the first
assessment and sustained to week 52.6,7
Kaivan Khavandi, SVP and Global Head, Respiratory,
Immunology/Inflammation R&D, said: "Today's
data build on the body of evidence supporting depemokimab as an
ultra-long-acting treatment and demonstrate significant reductions
in nasal polyps with a twice-yearly dosing regimen. With nearly 40%
of patients needing repeat surgeries and many requiring long-term
systemic corticosteroids, there
is a clear medical need for alternative treatment options to
provide sustained symptom improvement and help alleviate the
debilitating burden of this disease." 8,9
In pooled analyses of the secondary endpoints from both studies,
nominally significant improvements in favour of depemokimab versus
placebo were observed. These include changes from baseline in
rhinorrhoea VRS score, loss of smell VRS score, in addition to the
Lund-Mackay CT score, a sinus imaging assessment, and SNOT-22, a
disease-related quality of life measure.6,7
By week 52 in the pooled ANCHOR studies, 74% (n=200) of patients in
the depemokimab arm and 64% (n=164) patients in the placebo arm did
not have intervention with SCS, surgery, or disease modulating
medication (odds ratio [95% CI]: 0.58 [0.40, 0.86], nominal
p=0.006).6,7 When
considering intervention with surgery or disease modulating
medication alone, the results still trended in depemokimab's favour
with 88% (n=239) of depemokimab-treated patients not having surgery
or disease modulating medication vs. 83% (n=213) in the placebo
group (hazard ratio [95% CI]: 0.713 [0.453, 1.124],
p=0.146).
The proportion of patients who experienced adverse events (AEs) was
similar between the depemokimab and placebo groups in ANCHOR-1 (74%
[n=106] versus 79% [n=101]) and ANCHOR-2 (76% [n=98] versus 80%
[n=102]).6,7 These
are consistent with results from SWIFT-1 and SWIFT-2, the phase III
trials of depemokimab in patients with asthma with type 2
inflammation. 1 Additionally,
<1% of patients (n=2) receiving depemokimab and 1% (n=3) on
placebo, across both ANCHOR-1 and -2, discontinued treatment or
withdrew from the study due to AEs. No serious adverse events were
considered related to study treatment by
investigators.6,7
CRSwNP is a chronic condition that affects up to 4% of the general
population.5 The
current SOC, including surgery and SCS use, is suboptimal to
address the long-term impact of CRSwNP, and almost half of patients
live with poorly controlled symptoms. Although
short-term SCS temporarily improves symptoms, repeated use is known
to cause serious adverse events such as increased risk of diabetes,
cardiovascular disease, cataracts and osteoporosis. Surgery also
improves symptoms, but up to 40% of patients experience recurrence
of nasal polyps and symptoms within 18 months due to the underlying
inflammation not fully suppressed by surgery.10
Findings from ANCHOR-1 and -2, along with data from SWIFT-1 and
SWIFT-2, are being used to support regulatory filings in both
asthma with type 2 inflammation and CRSwNP in different countries
around the world. Depemokimab is not currently approved in any
country for either of these indications.
About ANCHOR-1 and
ANCHOR-26,7
The ANCHOR-1 and ANCHOR-2 clinical trials assessed the safety and
efficacy of depemokimab in patients with CRSwNP. Both were global,
52-week, randomised, double-blind, parallel group, placebo
controlled, multi-centre trials. The
full analysis set in ANCHOR-1 included 143 patients in the
depemokimab plus SOC arm and 128 in the placebo plus SOC arm; in
ANCHOR-2, 129 patients were included in the depemokimab plus SOC
arm and 128 in the placebo plus SOC arm.
All 528 patients had
inadequately controlled CRSwNP, including nasal polyps in both
nasal cavities (an endoscopic bilateral NPS ≥5), and had
either undergone previous surgery for CRSwNP, had received previous
treatment with SCS or were intolerant to SCS. Patients received
depemokimab or placebo at six-monthly intervals (26 weeks) in
addition to SOC (maintenance
intranasal corticosteroids).
About CRSwNP
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.2-4,10 IL-5
is a key cytokine (protein) in type 2 inflammation and is present
in up to 85% of people with CRSwNP.2-5,10 IL-5
is frequently found in high concentrations in sinus and nasal polyp
tissue of patients with CRSwNP and is associated with more severe
disease.
About depemokimab
Depemokimab, a monoclonal antibody that targets IL-5, is the first
ultra-long-acting biologic to be evaluated in phase III trials of
patients with CRSwNP. Depemokimab's extended half-life,
high-binding affinity and potency, supported six-month (26 week)
dosing regimens in the ANCHOR trials.6,7 In
these trials, depemokimab demonstrated early and sustained
inhibition of blood eosinophils, a key marker of IL-5
activity. 6,7,11
The
phase III programme includes evaluation of depemokimab
in other IL-5 mediated diseases. These include
severe asthma, eosinophilic granulomatosis with polyangiitis (EGPA)
and hypereosinophilic syndrome (HES). 1,12,13, 14 The first phase III trials in severe
asthma, SWIFT-1 and SWIFT-2, have been reported and published in
the New England Journal of
Medicine.1
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, GSK is 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.
Footnote
[I] The term nominal significance refers to results with a p-value
<0.05 where there was no control for multiple comparisons or
where the test was performed after a break in the multiplicity
hierarchy.
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Investor
Relations:
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Annabel
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James
Dodwell
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Mountifield
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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.
Han JK, et al.
Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE):
a randomised, double-blind, placebo-controlled, phase 3
trial. Lancet Respir
Med. 2021;9(10):1141-1153.
3.
Kato A, et al. Endotypes of
chronic rhinosinusitis: Relationships to disease phenotypes,
pathogenesis, clinical findings, and treatment
approaches. Allergy.
2022;77(3):812-826.
4.
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.
5. 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.
6.
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.
7.
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.
8. 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.
9. Global
Initiative for Asthma (GINA). Global strategy for asthma management
and prevention. 2021 main report. https://ginasthma.org/gina-reports/.
Accessed February 2025.
10. 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.
11.
Kato A, et al. Endotypes of chronic rhinosinusitis: Relationships
to disease phenotypes, pathogenesis, clinical findings, and
treatment approaches. Allergy. 2022;77(3):812-826.
12.
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.
13.
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.
14.
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.
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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