REG - GSK PLC - Positive results of ANCHOR trials of depemokimab

GSKAnnouncement

14/10/2024 07:00

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RNS Number : 9614H  GSK PLC  14 October 2024

Issued: 14 October 2024, London UK

 

GSK announces positive phase III results from ANCHOR trials for depemokimab in
chronic rhinosinusitis with nasal polyps

 

·  Primary endpoints met with statistically significant reduction in nasal
polyp size and nasal obstruction versus placebo plus standard of care, at 52
weeks

·  Depemokimab is an ultra-long-acting biologic administered once every six
months

·  Patients with chronic rhinosinusitis with nasal polyps (CRSwNP)
experience a range of symptoms which are widely underestimated and often
sub-optimally treated

 

 

GSK plc (LSE/NYSE: GSK) today announced positive headline results from the
phase III clinical trials ANCHOR-1 and ANCHOR-2, which assessed the efficacy
and safety of depemokimab versus placebo in adults with CRSwNP. Both trials
met their co-primary endpoints of a change from baseline in total endoscopic
nasal polyp score at 52 weeks and change from baseline in mean nasal
obstruction score from weeks 49 to 52. The overall incidence and severity of
treatment-emergent adverse events across both trials were similar in patients
treated with either depemokimab or placebo. Further analysis of these data is
ongoing. The full results of ANCHOR-1 and ANCHOR-2 will be presented at an
upcoming scientific congress.

 

Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D at
GSK, said: "Globally millions of people suffer from uncontrolled CRSwNP, the
majority of whom will exhibit markers of type 2 inflammation. These patients
have high corticosteroid exposure and often experience recurrence of nasal
polyps following surgery. We're very encouraged by the results from the ANCHOR
studies, which demonstrate the potential for depemokimab to offer targeted and
sustained suppression of a key inflammatory pathway underlying nasal polyp
growth and nasal obstruction. Today's data, along with recent phase III data
in severe asthma, will be used in regulatory filings around the world."

Depemokimab is the first ultra-long-acting biologic to be evaluated in phase
III trials with an extended half-life and high binding affinity and potency
for interleukin-5 (IL-5), which could enable dosing once every six-months for
patients with CRSwNP.(1-3) IL-5 is present at high levels in nasal polyp
tissue and is a key cytokine (protein) in type 2 inflammation.(1,4-7)

These data are part of GSK's aspirations to advance treatment goals for those
with type 2 inflammatory conditions like CRSwNP. Being able to deliver
sustained suppression of inflammation that drives the disease and its
progression, has the potential to benefit patients and clinicians by reducing
the risk of inflammation reoccurring due to missed doses. Increased dosing
intervals may also reduce the need for regular clinic time.

CRSwNP is a chronic condition that affects up to 4% of the general population,
of whom 40% have uncontrolled disease.(8,9) It is caused by inflammation of
the nasal lining that can lead to soft tissue growths, known as nasal
polyps.(4,10) People with CRSwNP experience symptoms such as nasal
obstruction, loss of smell, facial pressure, sleep disturbance, infections and
nasal discharge that can significantly affect their emotional and physical
well-being.(4,10 )

 

Up to 80% of people with CRSwNP show evidence of type 2 airway inflammation,
typically detected by blood eosinophil count as a biomarker, which is
associated with more severe disease and symptoms.(4-7,11)These patients are
likely to have a history of sinonasal surgery, which is accompanied by a high
risk of nasal polyp recurrence and have high OCS use that is known to be
associated with severe complications.(7,10,11)

 

Data from ANCHOR-1 and ANCHOR-2 along with data from SWIFT-1 and SWIFT-2, the
phase III trials of depemokimab in severe asthma, will be used  in regulatory
filings around the world. Depemokimab is currently not approved anywhere.

 

About ANCHOR-1 and ANCHOR-2(1,2)

ANCHOR-1 and ANCHOR-2 were replicate phase III clinical trials assessing the
safety and efficacy of depemokimab in patients with CRSwNP. Both were 52-week,
randomised, double-blind, parallel group, placebo controlled, multi-centre
trials. Number of subjects included in the Full Analysis Set of ANCHOR-1:
depemokimab = 143, placebo = 128 and in ANCHOR-2: depemokimab = 129, placebo =
128.

 

About the depemokimab development programme

Depemokimab's extended half-life, high potency and high binding affinity for
IL-5 means it has the potential to provide sustained inhibition of broad
inflammatory functions with dosing once every six-months. The phase III
programme includes evaluation of depemokimab in other IL-5 mediated diseases.
These include severe asthma,(3,13,14) eosinophilic granulomatosis with
polyangiitis (EGPA)(14) and hypereosinophilic syndrome (HES).(15) 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.(3)

 

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.

 

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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 Q2 Results for 2024.

 

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References

1.    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 Oct 2024

2.    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 Oct 2024
(https://clinicaltrials.gov/study/NCT05281523%20Accessed%20Oct%202024)

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

4.    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.

5.    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.

6.    Kato A, et al. Endotypes of chronic rhinosinusitis: Relationships to
disease phenotypes, pathogenesis, clinical findings, and treatment approaches.
Allergy. 2022;77(3):812-826.

7.    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.

8.    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.

9.    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.

10.  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.

11.  Laidlaw TM, et al. Chronic Rhinosinusitis with Nasal Polyps and Asthma.
J. Allergy Clin. Immunol. 2001;9(3):1133-1141.

12.  Silver J, et al. Biologic use and treatment patterns in patients with
chronic rhinosinusitis with nasal polyps: a US real-world study. Allergy
Asthma Clin Immunol. 2023;19(1):104.

13.  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) Last accessed May 2024.

14.  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 May 2024.

15.  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 May 2024.

16.  ClinicalTrials.gov. Depemokimab in Participants With Hypereosinophilic
Syndrome, Efficacy, and Safety Trial (DESTINY). Available at:
https://clinicaltrials.gov/study/NCT05334368 Accessed May 2024
(https://clinicaltrials.gov/study/NCT05334368%20Accessed%20May%202024) .

 

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