REG - GSK PLC - Depemokimab dual filing in China and Japan

GSKAnnouncement

28/01/2025 07:15

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RNS Number : 8470U  GSK PLC  28 January 2025

Issued: 28 January 2025 London UK

 

Depemokimab applications accepted for review in China and Japan for 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 new drug applications have been accepted for review by the China National Medical Products Administration and submitted to the Japanese Ministry of Health, Labour and Welfare for use of depemokimab in two indications.

 

In China, the submitted indications are for an add-on maintenance treatment of
asthma in adult and adolescent patients aged 12 and older with type 2
inflammation characterised by blood eosinophil count, and add-on maintenance
treatment of adult patients with inadequately controlled CRSwNP. In Japan, the
submitted indications are for treatment of severe or refractory bronchial
asthma and CRSwNP inadequately controlled with standard treatment.

 

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.(5) 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)

 

Asthma is a major health burden in China affecting an estimated 46 million
adults with approximately 15.5% reporting to have experienced an exacerbation
requiring a hospital visit in the last 12 months.(13)

CRSwNP is a chronic condition that affects up to 4% of the general population,
of whom 40% have uncontrolled disease.(8,12,14) It is estimated that about 107
million people in China suffer from chronic sinusitis, about 1/3 of whom have
chronic sinusitis with nasal polyps.(8,15-17) In Japan, it is estimated that
there are 2 million people with chronic sinusitis, of which about 200,000 are
subject to surgery due to nasal polyps.(18)

 

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).(1,19) 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.(20)

( )

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)(21) and DESTINY for hypereosinophilic
syndrome (HES).(22)

 

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
(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).(4,22,23) Asthma presents a significant financial burden to
patients as exacerbations place a resource burden on healthcare systems due to
emergency department visits and hospitalisations.(5,24)

 

CRSwNP is caused by inflammation of the nasal lining that can lead to soft
tissue growths, known as nasal polyps.(8,11)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.(5,6,25-29) 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.

 

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References

1.       Jackson DJ, et al. Six Monthly Depemokimab in Severe Asthma
With an Eosinophilic Phenotype. NEJM. Published on September 9 at NEJM.org
(https://www.nejm.org/doi/full/10.1056/NEJMoa2406673) .

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
(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
(https://clinicaltrials.gov/study/NCT05281523%20Accessed%20January%202025) .

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International Association of Providers of AIDS Care (JIAPAC). 2021;20.

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https://ginasthma.org/ (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
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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
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Res Opin. 2020;36(11):1897-1911.

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severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics:
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13.     Huang K, Yang T, Xu J, et al. Prevalence, risk factors, and
management of asthma in China: a national cross-sectional
study. Lancet. 2019; 394:407-418.

14.     van der Veen J, et al. Real-life study showing uncontrolled
rhinosinusitis after sinus surgery in a tertiary referral centre. Allergy.
2017;72(2):282-290.

15.     Liu Z, et al. Chinese Society of Allergy and Chinese Society of
Otorhinolaryngology-Head and Neck Surgery Guideline for Chronic
Rhinosinusitis. Allergy Asthma Immunol Res. 2020;12(2):176-237.

16.     Wu Q, et al. Efficacy and safety of omalizumab in chronic
rhinosinusitis with nasal polyps: a systematic review and meta-analysis of
randomised controlled trials. BMJ Open. 2021 Sep;11(9):e047344.

17.     Wang Chengshuo, Zhang Luo. Biologics for the treatment of chronic
rhinosinusitis with nasal polyps. Chinese Journal of Otolaryngology-Head and
Neck Surgery, 2023, 58(3) : 193-199.

18.     JESREC Study About refractory eosinophilic sinusitis available at
https://jesrec.jp/general/disease.html.
(https://jesrec.jp/general/disease.html.%20Last%20accessed%20September%202023)
Accessed January 2025

19.     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
(https://clinicaltrials.gov/study/NCT05243680) Accessed January 2025.

20.     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
(https://clinicaltrials.gov/study/NCT04718389) Accessed January 2025.

21.     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
(https://clinicaltrials.gov/study/NCT05263934) Accessed January 2025.

22.     ClinicalTrials.gov. Depemokimab in Participants With
Hypereosinophilic Syndrome, Efficacy, and Safety Trial (DESTINY) Available at:
https://clinicaltrials.gov/study/NCT05334368
(https://clinicaltrials.gov/study/NCT05334368) Accessed January 2025.

23.     World Health Organisation. Asthma Key Facts. Available at
https://www.who.int/news-room/fact-sheets/detail/asthma
(https://www.who.int/news-room/fact-sheets/detail/asthma) Accessed January
2025

24.     Israel, E, et al. Severe and Difficult-to-Treat Asthma in Adults.
N Engl J Med 2017;377:965-76.

25.     Buchheit KM, et al. Mepolizumab targets multiple immune cells in
aspirin-exacerbated respiratory disease. J Allergy Clin Immunol.
2021;148(2):574-584.

26.     Barretto KT, et al. Human airway epithelial cells express a
functional IL-5 receptor. Allergy. 2020;75(8):2127-2130.

27.     Bajbouj K, et al. IL-5 receptor expression in lung fibroblasts:
Potential role in airway remodelling in asthma. Allergy. 2023;78(3):882-885.

28.     Siddiqui S, et al. Eosinophils and tissue remodeling: Relevance to
airway disease. J Allergy Clin Immunol. 2023;152(4):841-857.

29.     Bergantini L, et al. Regulatory T cell monitoring in severe
eosinophilic asthma patients treated with mepolizumab. Scand J Immunol.
2021;94(1):e13031.

 

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