FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of September 2025
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Update on RESOLUTE Phase III trial
17 September 2025
Update on the
RESOLUTE Phase III trial for Fasenra in
chronic obstructive pulmonary disease
The RESOLUTE Phase III trial of
AstraZeneca's Fasenra (benralizumab), despite showing numerical
improvement, did not achieve statistical significance in the
primary endpoint in patients with chronic obstructive pulmonary
disease (COPD).[i]
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D,
AstraZeneca, said: "COPD, which remains a leading cause of death
worldwide, is a complex, heterogeneous disease and we continue to
advance other promising approaches in our pipeline to address the
unmet needs of patients. With its well-established ability to
target and eliminate eosinophils, Fasenra has helped transform treatment of severe
asthma, and more recently has demonstrated a significant effect in
eosinophilic granulomatosis with polyangiitis and hypereosinophilic
syndrome."
The safety and tolerability profile for Fasenra in the trial was consistent with the known
profile of the medicine.1 The
Company will analyse the full data set from RESOLUTE to further
understand the results, which will be shared with the scientific
community in the future.
Fasenra is currently
approved as an add-on maintenance treatment for severe eosinophilic
asthma (SEA) in more than 80 countries, including the US, Japan, EU
and China.2-5 It
is also approved for SEA in children and adolescents ages six and
above in the US and Japan.6 Fasenra is
also approved in more than 60 countries for the adult treatment of
eosinophilic granulomatosis with polyangiitis
(EGPA),7 and
is under regulatory review for the treatment
of hypereosinophilic syndrome (HES).
Notes
COPD
COPD is a debilitating, irreversible and progressive
disease.8-11 COPD
exacerbations are life-threatening and accelerate disease
progression, irreversible lung damage, increased hospitalisations,
subsequent exacerbations and death.8-12 COPD
is one of the most common chronic respiratory diseases, affecting
391 million people globally,8 and
is among the highest causes of morbidity and mortality
globally.13
RESOLUTE
RESOLUTE is a randomised, double-blind, placebo-controlled Phase
III trial to evaluate the efficacy and safety of benralizumab 100
mg in people with moderate to very severe COPD with a history of
frequent COPD exacerbations and an elevated blood eosinophil count
(BEC) ≥ 300 cells/µL.1,4 Participants
in the trial had a history of at least two COPD exacerbations in
the year prior to enrolment, were on background treatment with
ICS/LABA/LAMA and were a current or former
smoker.14 The
primary endpoint was the annualised rate of moderate or severe
exacerbations in patients with three or more exacerbations in the
previous year. The RESOLUTE trial population was informed by the
analysis from the Phase III GALATHEA and
TERRANOVA trials.
Participants (n=689) were randomised to receive placebo-solution
or Fasenra (100 mg every four weeks for the first three
doses and then every eight weeks thereafter).14 All
participants remained on their background therapy,
ICS/LABA/LAMA.14
In the trial, moderate COPD exacerbations were defined by
symptomatic worsening of COPD requiring the use of systemic
corticosteroids for at least three days and use of
antibiotics.14 Severe
exacerbations were defined by hospitalisation or death due to
COPD.14 Key
secondary endpoints included the annualised rate of severe
exacerbations, change from baseline in SGRQ total score; and change
from baseline in pre-dose/pre-bronchodilator FEV1 at Week
56.14
Fasenra
Fasenra (benralizumab) is
currently approved as an add-on maintenance treatment for adults
with SEA in more than 80 countries, including the US, Japan, EU and
China.2-5 More
than 150,000 patients globally are currently
taking Fasenra.15 In
the US and Japan, Fasenra is also approved in SEA patients six years
and older.6 Fasenra is
also approved in more than 60 countries for the treatment of
eosinophilic granulomatosis with polyangiitis (EGPA) in
adults.7
The NATRON Phase III trial evaluating Fasenra (benralizumab) in people with
hypereosinophilic syndrome (HES) successfully met the primary
endpoint. Fasenra, dosed monthly in a single injection,
demonstrated a statistically significant increase in the time to
first worsening or flare compared to placebo.16
Fasenra was developed by
AstraZeneca and is in-licensed from BioWa, Inc., a wholly owned
subsidiary of Kyowa Kirin Co., Ltd.,
Japan.
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca
BioPharmaceuticals, is a key disease area and growth driver to the
Company.
AstraZeneca is an established leader in respiratory care with a
50-year heritage and a growing portfolio of medicines in
immune-mediated diseases. The Company is committed to addressing
the vast unmet needs of these chronic, often debilitating, diseases
with a pipeline and portfolio of inhaled medicines, biologics and
new modalities aimed at previously unreachable biologic targets.
Our ambition is to deliver life-changing medicines that help
eliminate COPD as a leading cause of death, eliminate asthma
attacks and achieve clinical remission in immune-mediated
diseases.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca's innovative
medicines are sold in more than 125 countries and used by millions
of patients worldwide. Please visit astrazeneca.com and
follow the Company on social media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team,
please click
here. For Media
contact, click
here.
References
1. Wechsler ME, et al. Benralizumab
versus Mepolizumab for Eosinophilic Granulomatosis with
Polyangiitis. N Engl J
Med.
2024;390(10):911-921.
2. Fasenra (benralizumab) US
prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761070s021lbl.pdf.
[Last accessed: September 2025].
3.
EMA Fasenra Product Information. Available at:
https://www.ema.europa.eu/en/documents/product-information/fasenra-epar-product-information_en.pdf.
[Last accessed: September 2025].
4. AstraZeneca news release. Available
at: https://www.astrazeneca.com/media-centre/press-releases/2024/fasenra-approved-in-china-for-the-treatment-of-severe-eosinophilic-asthma.html [Last
accessed: September 2025]
5. AstraZeneca news release. Available
at: https://www.astrazeneca.com/media-centre/press-releases/2018/fasenra-recieves-approval-in-japan-19012018.html# [Last
accessed: September 2025].
6. AstraZeneca Annual Report 2024.
Available at: Annual report
2024. [Last accessed: September
2025].
7.
AstraZeneca Data on File. 2025. Fasenra Program Update August 2025.
REF-287072.
8.
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;6(10):447-456
9. Kim G-D, et al. Macrophage
Polarization and Functions in Pathogenesis of Chronic Obstructive
Pulmonary Disease. Int J Mol
Sci. 2024;25(11):5632.
10. Vogelmeier CF, AstraZeneca H1 and Q2
Results. Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/h1-and-q2-2025.html.
[Last accessed: September 2025]Goals of COPD treatment: Focus on
symptoms and exacerbations. Respir Med. 2020;166:105938.
11. Quaderi SA, Hurst JR. The unmet global
burden of COPD. Global Health, Epid and
Geno. 2018;3,e4.
12. Alwafi H, et al. Trends in hospital
admissions and prescribing due to chronic obstructive pulmonary
disease and asthma in England and Wales between 1999 and 2020: an
ecological study. BMC Pulm
Med.
2023;34(2):49.
13. WHO Fact Sheet. The Top 10 Causes
of Death. Available at: https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death.
[Last accessed: September 2025].
14. Clinicaltrial.gov. Efficacy and Safety
of Benralizumab in Moderate to Very Severe Chronic Obstructive
Pulmonary Disease (COPD) With a History of Frequent Exacerbations
(RESOLUTE). Available at: https://clinicaltrials.gov/study/NCT04053634. [Last
accessed: September 2025].
15.
AstraZeneca Data on File. 2025. Fasenra Number of Cumulative
Patients. REF-279705.
16. AstraZeneca H1 and Q2 Results 2025.
Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/h1-and-q2-2025.html.
[Last accessed: September 2025].
Matthew Bowden
Company Secretary
AstraZeneca PLC
[i] The
primary endpoint was the annualised rate of moderate or severe
chronic obstructive pulmonary disease (COPD)
exacerbations.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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AstraZeneca
PLC
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Date: 17 September 2025
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By: /s/
Matthew Bowden
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Name:
Matthew Bowden
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Title:
Company Secretary
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