Issued: 21
May 2024, London UK
GSK
announces positive results from phase III severe asthma trials of
depemokimab
· Primary endpoints met in SWIFT-1 and SWIFT-2 trials with
statistically significant and clinically meaningful reductions in
exacerbations over 52 weeks vs. placebo
· Depemokimab has the potential to be the first approved
ultra-long-acting biologic with a six-month
dosing schedule for severe asthma
· Six-month dosing could simplify treatment to support millions
of patients with severe asthma
GSK plc (LSE/NYSE: GSK) today
announced positive headline results from the phase III clinical
trials SWIFT-1 and SWIFT-2, which assessed the efficacy and safety
of depemokimab versus placebo in adults and adolescents with
severe asthma with
type 2 inflammation characterised by blood eosinophil
count.1,2 Both SWIFT-1 and
SWIFT-2 met their primary endpoints of a reduction in the
annualised rate of clinically significant exacerbations (asthma
attacks) over 52 weeks.1,2 Across both trials the overall incidence and severity of
treatment-emergent adverse events were similar in patients treated with either depemokimab or
placebo. Further analysis of these data is
ongoing.
Depemokimab is the first ultra-long-acting
biologic to be evaluated in phase III trials with a
binding affinity and high potency for interleukin-5 (IL-5),
enabling six-month dosing intervals for patients with severe
asthma.1,2,3
IL-5 is known to be a key cytokine (protein) in
type 2 inflammation.4,5 This inflammation, typically
identified by elevated blood eosinophil
count, is the underlying pathology responsible for more than 80% of
people with severe asthma and can lead to unpredictable
exacerbations.5,6
Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology
R&D, said: "These results add to
the established body of evidence that
targeted inhibition of IL-5 plays a key role in reducing type 2 inflammation that
drives severe asthma exacerbations. Depemokimab could offer the possibility of
sustained inhibition of this
pathway, with a dosing schedule of just two
injections per year. This is important
as research shows that 73%
of physicians7 believe longer dosing
intervals would be beneficial to patients
who are often juggling multiple therapies."
Expertise in respiratory diseases
and the science of IL-5 has informed the ongoing evidence
generation program evaluating the impact of six-month dosing of sustained
IL-5 inhibition in patients achieving clinical remission in
severe asthma.5 The full
results of SWIFT-1 and SWIFT-2 will be presented at an upcoming
scientific congress and will be used to support
regulatory submissions to
health authorities worldwide.
Depemokimab is currently not
approved anywhere in the world.
About the depemokimab development programme
The phase III programme consists
of SWIFT-1 and SWIFT-2 in
severe asthma,
along with an open label extension study
(AGILE).1,2,8 SWIFT-1 and SWIFT-2 were replicate
52-week, randomised, double-blind, placebo-controlled,
parallel-group, multi-centre phase III clinical
trials.1,2 The trials assessed
the efficacy and safety of depemokimab adjunctive therapy in 375
and 380 participants who were randomised to receive depemokimab or
a placebo, in addition to their standard of care treatment with
medium to high-dose inhaled corticosteroids plus at least one
additional controller.1,2
An additional study (NIMBLE) is underway to
assess the efficacy and safety of depemokimab when participants
with severe asthma are switched from mepolizumab
or benralizumab.9
Depemokimab's extended half-life
has the potential to provide sustained inhibition of broad
inflammatory functions and is being investigated in a variety of
type 2 inflammatory conditions.1,2,8-13
Depemokimab is also currently being evaluated in
phase III trials across a range of other IL-5 mediated diseases, including eosinophilic granulomatosis with
polyangiitis (EGPA), chronic rhinosinusitis with nasal polyps
(CRSwNP) and hypereosinophilic syndrome
(HES).9-12
About severe asthma and type
2 inflammation
Severe asthma is defined as asthma
that requires treatment with high-dose inhaled corticosteroids plus
a second controller (and/or systemic corticosteroids) or biologic
therapy, to prevent it from becoming 'uncontrolled' or which
remains 'uncontrolled' despite therapy.5,14 In more than 80% of
patients with severe asthma, their condition is driven by type 2
inflammation in which patients exhibit elevated
levels of eosinophils (a type of white blood
cell).5,6 Blood eosinophils count can be measured via a simple blood
test. IL-5 is a core cytokine
(protein) in type 2 inflammation alongside IL-4 and
IL-13.5 Type 2 inflammation
drives the underlying pathology in a variety of immune-mediated
conditions. IL-5 is responsible for the growth, activity and
survival of eosinophils.5
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 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.
GSK
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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 Q1 Results for 2024.
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References:
1.
ClinicalTrials.gov. Placebo-controlled Efficacy and Safety Study of
GSK3511294 (Depemokimab) in Participants With Severe Asthma With an
Eosinophilic Phenotype - (SWIFT-1) Available at: https://classic.clinicaltrials.gov/ct2/show/NCT04719832
Last accessed May 2024.
2.
ClinicalTrials.gov. A Study of GSK3511294
(Depemokimab) in Participants With Severe Asthma With an
Eosinophilic Phenotype (SWIFT-2) Available at:
https://classic.clinicaltrials.gov/ct2/show/NCT04718103
Accessed May 2024.
3.
Singh D, et al. A Phase 1 study of the long-acting
anti-IL-5 monoclonal antibody GSK3511294 in patients with asthma.
Br J Clin Pharmacol.
2022;88:702-712.
4.
Principe S, et
al. Severe asthma: Targeting the IL-5 pathway. Clin Exp
Allergy. 2021 Aug;51(8):992-1005
5.
Global Initiative for Asthma. Global Strategy for
Asthma Management and Prevention,2024. Updated May 2024. Available
at: https://ginasthma.org/.
Accessed May 2024.
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.
Research Partnership Quant uptake Market Research,
200 HCPs Top two box on a seven-point scale where seven equaled
"highly beneficial".
8.
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
Last accessed May 2024.
9.
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 May 2024.
10. 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 May 2024.
11. 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 May 2024
12. 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 May 2024.
13. ClinicalTrials.gov. Depemokimab in
Participants With Hypereosinophilic Syndrome, Efficacy, and Safety
Trial (DESTINY) Available at:
https://clinicaltrials.gov/study/NCT05334368
Accessed May 2024.
14. GINA Difficult-to-treat and severe asthma in adolescent and
adult patients: diagnosis and management. Global Strategy for
Asthma Management and Prevention 2021. Available at:
https://ginasthma.org/wp-content/uploads/2021/08/SA-Pocket-guide-v3.0-SCREEN-WMS.pdf.
Accessed May 2024.