REG - GSK PLC - ANCHOR results presented at 2025 AAAAI

GSKAnnouncement

03/03/2025 07:15

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RNS Number : 9819Y  GSK PLC  03 March 2025

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%  urn:newsml:reuters.com:*:n=106 versus 79%
 urn:newsml:reuters.com:*:n=101) and ANCHOR-2 (76%  urn:newsml:reuters.com:*:n=98 versus 80%  urn:newsml:reuters.com:*: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-2(6,7)

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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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.

 

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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/stoken/default+domain/REPRINTS_36509/full?redirectUri=/doi/full/10.1056/NEJMoa2406673)
 

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

 

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