REG - GSK PLC - Nucala MATINEE data in COPD published in NEJM

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RNS Number : 9389G  GSK PLC  01 May 2025

Issued: 30 April 2025, London UK

 

Nucala (mepolizumab) delivers clinically meaningful and statistically
significant reduction in COPD exacerbations, with positive MATINEE trial
results published in New England Journal of Medicine

 

·   21% reduction in annualised rate of moderate/severe exacerbations in a
wide COPD population

·    31% reduction in annualised rate of moderate/severe exacerbations in
the sub-group of patients with chronic bronchitis only in post-hoc analysis

·   35% reduction in annualised rate of exacerbations leading to emergency
department visit and/or hospitalisation secondary endpoint*

 

 

 

GSK plc (LSE/NYSE: GSK) today announced positive results for Nucala
(mepolizumab) in the treatment of chronic obstructive pulmonary disease
(COPD), with the full results from the MATINEE phase III trial published in
the New England Journal of Medicine. The trial evaluated mepolizumab, a
monoclonal antibody targeting interleukin-5 (IL-5), in a wide spectrum of
patients with COPD, including the most severe and difficult to treat as
categorised in the Global Initiative for Chronic Obstructive Lung Disease
(GOLD) guidelines.(1) Patients recruited had evidence of type 2 inflammation,
characterised by blood eosinophil count, and included those with chronic
bronchitis, emphysema-only or both.(2) The monthly administration of
mepolizumab demonstrated improvement across all exacerbation endpoints, which
were maintained over the 2-year (up to 104 weeks) study period.(2)

 

In the full population studied, mepolizumab showed a clinically meaningful and
statistically significant 21% reduction in the annualised rate of
moderate/severe exacerbations versus placebo, meeting the primary endpoint for
MATINEE (rate ratio [95% confidence interval (CI)]: 0.79 [0.66, 0.94];
P=0.011) (AER mepolizumab = 0.80 exacerbations per year versus placebo = 1.01)
n= 804; mepolizumab = 403, placebo = 401).(2) In addition, mepolizumab also
showed a 31% reduction in the annualised rate of moderate/severe exacerbations
versus placebo in a post-hoc analysis of patients with clinician assessed
chronic bronchitis only (rate ratio [95% CI]: 0.69 [0.51, 0.93] n=338:
mepolizumab = 170, placebo = 168).(2)

 

A 35% reduction in the annualised rate of exacerbations leading to emergency
department visits and/or hospitalisation was shown with mepolizumab versus
placebo, a secondary endpoint of the MATINEE study (rate ratio [95% CI]: 0.65
[0.43, 0.96] nominally significant after adjustment for multiplicity) (AER
mepolizumab = 0.13 exacerbations per year versus placebo = 0.20)). Mepolizumab
is the only biologic with data that shows a reduction in emergency department
visits and/or hospitalisation in a phase III trial. Reducing hospitalisations
is a key goal of COPD management.(3) COPD-related hospitalisations are a major
healthcare challenge and projected to become the number one cause of medical
admissions.(4) If hospitalised due to COPD, one in ten patients will die
during the stay, up to one in four over the next year and half will lose their
lives within five years.(5,6)

 

Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation
R&D, GSK said: "Today's MATINEE results show that mepolizumab can help
prevent exacerbations, including those leading to emergency department visits
and/or hospitalisation. These exacerbations are devastating for patients,
known to cause irreversible lung damage, worsening of symptoms and increased
mortality. For decades, we have and will continue to push the boundaries of
innovation to prevent disease progression and make a meaningful impact on the
lives of people affected by COPD."

 

Frank Sciurba, Professor of Pulmonary, Allergy and Critical Care Medicine, and
lead author of the MATINEE trial said: "Every physician will know the feeling
of seeing a patient hospitalised due to an exacerbation that could have
possibly been prevented. The MATINEE trial uncovers new possibilities in the
treatment landscape for COPD patients with type 2 inflammation, as we strive
to target drivers of disease and improve the lives of patients suffering with
COPD."

 

High response rates were observed in Patient Reported Outcomes (PROs) in the
mepolizumab group, however there was no difference observed for St George's
Respiratory Questionnaire (SGRQ), the COPD Assessment Test (CAT) and the
Evaluating Respiratory Symptoms (E-RS) in the full study population versus
placebo.(2) The incidence of adverse events were similar between mepolizumab
and placebo (mepolizumab vs placebo: 74% vs 77%), with the most frequent being
exacerbation or worsening of COPD (mepolizumab vs placebo: 12% vs 15%) and
COVID-19 infection (12% vs 12%).(2)

 

Nucala is not approved for the treatment of COPD in any country. Regulatory
submissions are under review in several countries, including the US, China and
the EU. The US FDA has provided a PDUFA date of May 7, 2025.

 

*Nominally significant after adjustment for multiplicity

 

About MATINEE

MATINEE is a phase III, randomised (1:1), double-blind, parallel-group trial
assessing the efficacy and safety of mepolizumab 100 mg as add-on therapy,
administered subcutaneously every 4 weeks for 52-104 weeks, versus placebo in
addition to optimal inhaled triple therapy (dual long-acting bronchodilators
plus inhaled corticosteroid).(2)

 

Positive results were achieved in a wide population of patients with COPD. The
efficacy and safety of mepolizumab was assessed in patients with COPD with
evidence of type 2 inflammation, characterised by a blood eosinophil count
(≥300 cells/µL). Patients could participate with a range of clinical
presentations of COPD including chronic bronchitis, emphysema only or a
combination of both. The condition of patients ranged in severity from
moderate to very severe, or stages 2-4 as assessed by the medically recognised
scale of Global Initiative for Chronic Obstructive Lung Disease (GOLD).(2) The
full analysis of MATINEE included 403 patients enrolled on the mepolizumab arm
and 401 on placebo, all of whom had experienced exacerbations in the previous
year despite receiving optimised inhaled maintenance therapy.(2)

 

About chronic obstructive pulmonary disease (COPD) and type 2 inflammation

COPD is a progressive and heterogeneous inflammatory lung disease that
includes chronic bronchitis and/or emphysema.(3) It affects more than 390
million people globally and is the third leading cause of death.(7,8) Patients
with COPD experience persistent respiratory symptoms such as breathlessness,
cough, and sputum along with progressive airflow obstruction due to the
chronic inflammation, that impact daily life.(3) Type 2 inflammation is
present in a variety of immuno-inflammatory conditions and is a major
contributor to symptoms and exacerbations in up to 40% of people with
COPD.(2,9)

 

Despite inhaled triple therapy, many patients experience persistent symptoms
and exacerbations.(10) Exacerbations are acute episodes of worsening COPD
symptoms, which can result in hospitalisation and irreversible lung damage.(3)
Early intervention is important in preventing exacerbations and cumulative
lung damage.(3)

 

About Nucala

Nucala is a monoclonal antibody that targets and binds to interleukin-5
(IL-5), a key messenger protein (cytokine) in type 2 inflammation. Nucala has
been developed for the treatment of a range of IL-5 mediated diseases
associated with type 2 inflammation. It is currently approved for use in the
US and Europe across four IL-5 mediated conditions. Nucala is currently not
indicated for COPD in any country.

 

For product and important safety information please consult the country
relevant summary of product characteristics.

EU available
at: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf
(https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf)
. The US prescribing information is available at:
NUCALA-PI-PIL-IFU-COMBINED.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-COMBINED.PDF)
.

 

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 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.

 

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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 in
the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q1 Results for 2025.

 

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References:

1.    Hoffman M. Lung Disease & Respiratory Health. COPD Stages and the
GOLD Criteria. WebMD. Available at:
https://www.webmd.com/lung/copd/gold-criteria-for-copd. 14 May 2023. Last
accessed April 2025.

2.    Sciurba F, et al. Mepolizumab to prevent exacerbations in COPD with
an eosinophilic phenotype. NEJM Published 1 May issue. Available at
https://www.nejm.org/stoken/default+domain/REPRINTS_36868_2/full?redirectUri=/doi/full/10.1056/NEJMoa2413181
(https://urldefense.com/v3/__https:/www.nejm.org/stoken/default*domain/REPRINTS_36868_2/full?redirectUri=*doi*full*10.1056*NEJMoa2413181__;Ky8vLy8!!AoaiBx6H!08WAwSP1DtfWMyYZAStaU8GdJl5V7CmWFDaxRbWlpQ2F625TyC3fNBAOdVTRa-aFC2BSA1V5uarcb1wTlQ$)

3.    Global Initiative for Chronic Obstructive Lung Disease. 2025 Gold
Report. Available at: https://goldcopd.org/ (https://goldcopd.org/) Last
accessed April 2025.

4.    Khakban A, et al. The Projected Epidemic of Chronic Obstructive
Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based
Perspective. Am J Respir Crit Care Med. 2017;195(3):287-291.
https://www.atsjournals.org/doi/10.1164/rccm.201606-1162PP
(https://www.atsjournals.org/doi/10.1164/rccm.201606-1162PP) Waeijen-Smit K,
et al. Global mortality and readmission rates following COPD
exacerbation-related hospitalisation: a meta-analysis of 65 945 individual
patients. ERJ Open Res. 2024 Feb 26;10(1):00838-2023. doi:
https://publications.ersnet.org/content/erjor/10/1/00838-2023
(https://publications.ersnet.org/content/erjor/10/1/00838-2023)

5.    van Hirtum PV, et al. Long term survival after admission for COPD
exacerbation: A comparison with the general population. Respir Med.
2018;137:77-82. doi:
https://www.resmedjournal.com/article/S0954-6111(18)30052-0/fulltext
(https://www.resmedjournal.com/article/S0954-6111(18)30052-0/fulltext)

6.    Adeloye D, et al. Global, regional, and national prevalence of, and
risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a
systematic review and modelling analysis. Lancet Respir Med.
2022;10(5):447-458. doi: https://pmc.ncbi.nlm.nih.gov/articles/PMC9050565/
(https://pmc.ncbi.nlm.nih.gov/articles/PMC9050565/)

7.    Chen S, et al. The global economic burden of chronic obstructive
pulmonary disease for 204 countries and territories in 2020-50: a
health-augmented macroeconomic modelling study. Lancet Glob Health.
2023;11(8):e1183-e1193. doi:
https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(23)00217-6/fulltext
(https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(23)00217-6/fulltext)

8.    Rabe KF, et al. Targeting Type 2 Inflammation and Epithelial Alarmins
in Chronic Obstructive Pulmonary Disease: A Biologics Outlook. Am J Respir
Crit Care Med. 2023;208(4):395-405. doi:
https://www.atsjournals.org/doi/10.1164/rccm.202303-0455CI
(https://www.atsjournals.org/doi/10.1164/rccm.202303-0455CI)

9.    Chen S, Miravitlles M, Rhee CK, et al. Patients with Chronic
Obstructive Pulmonary Disease and Evidence of Eosinophilic Inflammation
Experience Exacerbations Despite Receiving Maximal Inhaled Maintenance
Therapy. Int J Chron Obstruct Pulmon Dis. 2022 Sep 9;17:2187-2200. doi:
https://www.dovepress.com/patients-with-chronic-obstructive-pulmonary-disease-and-evidence-of-eo-peer-reviewed-fulltext-article-COPD
(https://www.dovepress.com/patients-with-chronic-obstructive-pulmonary-disease-and-evidence-of-eo-peer-reviewed-fulltext-article-COPD)

 

 

 

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