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 April 2025
Commission
File Number: 001-11960
AstraZeneca PLC
1
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi approved in EU for AEGEAN
04 April 2025
Imfinzi-based perioperative regimen approved in the EU
for
resectable non-small cell lung cancer
Approval based on AEGEAN Phase III trial results which showed
a 32% reduction in the risk of recurrence, progression or death vs.
neoadjuvant chemotherapy alone
AstraZeneca's Imfinzi (durvalumab) in combination with
chemotherapy has been approved in the European Union (EU) for the
treatment of adults with resectable non-small cell lung cancer
(NSCLC) at high risk of recurrence and no epidermal growth factor
receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)
rearrangements. In this regimen, patients are treated
with Imfinzi in combination with neoadjuvant chemotherapy
before surgery and as adjuvant monotherapy after
surgery.
The approval by the European Commission follows
the positive
opinion of the Committee
for Medicinal Products for Human Use and is based on results from
the pivotal AEGEAN trial,
which were published in The
New England Journal of Medicine.
Each year in Europe, there are more than 450,000 people diagnosed
with lung cancer.1 Around
25-30% of all patients with NSCLC, the most common form of lung
cancer, are diagnosed at an early stage to have surgery with
curative intent.2-3 However,
the majority of patients with resectable disease will develop
recurrence and only 36-46% of patients with Stage II disease will
survive for five years.4-5 This
decreases to 24% for patients with Stage IIIA disease and 9% for
patients with Stage IIIB disease, reflecting a high unmet medical
need.4
Professor Martin Reck, Head of the Department of Thoracic Oncology
at the Lung Clinic Grosshansdorf, Germany, member of the AEGEAN
Steering Committee and investigator in the trial, said: "Today's
approval provides an important new treatment option that should
become a backbone combination approach for patients in Europe with
resectable non-small cell lung cancer, who have historically faced
high rates of recurrence and a poor prognosis. When added to
neoadjuvant chemotherapy, perioperative durvalumab meaningfully
improved outcomes in this curative-intent setting, significantly
extending the time patients lived without their cancer
returning."
Dave Fredrickson, Executive Vice President, Oncology Haematology
Business Unit, AstraZeneca, said: "Today's approval marks an
important step towards improving outcomes for patients in Europe
with resectable non-small cell lung cancer, enabling more patients
to access this important immunotherapy-based regimen. This new
indication builds on the established role
of Imfinzi in unresectable disease and underscores our
commitment to transforming care in the early stages of lung cancer
where there is the greatest potential for
cure."
Results from a planned interim analysis of event-free survival
(EFS) showed a statistically significant and clinically meaningful
32% reduction in the risk of recurrence, progression events or
death versus neoadjuvant chemotherapy alone in patients treated
with the Imfinzi-based perioperative regimen (32% data maturity;
EFS hazard ratio [HR] 0.68; 95% confidence interval [CI] 0.53-0.88;
p=0.003902). In a final analysis of pathologic complete response
(pCR), treatment with Imfinzi plus neoadjuvant chemotherapy before surgery
resulted in a pCR rate of 17.2% versus 4.3% for patients treated
with neoadjuvant chemotherapy alone (difference in pCR 13.0%; 95%
CI 8.7-17.6).
Additionally, interim overall survival (OS) results presented at
the 2024 World Conference on Lung Cancer showed a favourable trend
with the Imfinzi-based perioperative regimen (35% data maturity;
median OS: not reached [NR] versus 53.2 months; HR=0.89; 95% CI
0.70-1.14). The OS data were not tested for statistical
significance at this interim analysis and will continue to be
assessed as a key secondary endpoint at final
analysis.
Imfinzi was
generally well tolerated, and no new safety signals were observed
in the neoadjuvant and adjuvant settings. Further,
adding Imfinzi to
neoadjuvant chemotherapy was consistent with the known profile for
this combination and did not compromise patients' ability to
complete surgery versus chemotherapy alone.
Imfinzi is
approved in the US, China and several other countries in this
setting based on the AEGEAN results. Regulatory applications are
currently under review in Japan and additional countries in this
indication.
Imfinzi is
the global standard of care based on OS in the curative-intent
setting of unresectable, Stage III NSCLC in patients whose disease
as not progressed after chemoradiotherapy (CRT) based on the
PACIFIC Phase III trial.
Notes
Lung cancer
Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-fifth of all cancer
deaths.6-7 Lung
cancer is broadly split into NSCLC and small cell lung cancer
(SCLC), with 80-85% of patients diagnosed with
NSCLC.8-9 An
estimated 28,000 people are treated for resectable NSCLC across the
five major European countries each year.10
Early-stage lung cancer diagnoses are often only made when the
cancer is found on imaging for an unrelated
condition.11-12 The
majority of patients with resectable disease eventually develop
recurrence despite complete tumour resection and adjuvant
chemotherapy.5
AEGEAN
AEGEAN is a randomised, double-blind, multi-centre,
placebo-controlled global Phase III trial
evaluating Imfinzi as perioperative treatment for patients with
resectable Stage IIA-IIIB (Eighth Edition AJCC Cancer Staging
Manual) NSCLC, irrespective of PD-L1 expression. Perioperative
therapy includes treatment before and after surgery, also known as
neoadjuvant/adjuvant therapy. In the trial, 802 patients were
randomised to receive a 1500mg fixed dose
of Imfinzi plus chemotherapy or placebo plus
chemotherapy every three weeks for four cycles prior to surgery,
followed by Imfinzi or placebo every four weeks (for up to 12
cycles) after surgery. Patients with known EGFR or ALK genomic
tumour aberrations were excluded from the primary efficacy
analyses.
In the AEGEAN trial, the primary endpoints were pCR, defined as no
viable tumour in the resection specimen (including lymph nodes)
following neoadjuvant therapy, and EFS, defined as the time from
randomisation to an event like tumour recurrence, progression
precluding definitive surgery, or death. Key secondary endpoints
were major pathologic response, defined as residual viable tumour
of less than or equal to 10% in the resected primary tumour
following neoadjuvant therapy, disease-free survival, OS, safety
and quality of life. The final pathologic response analyses were
performed after all patients had the opportunity for surgery and
pathology assessment per the trial protocol. The trial enrolled
participants from 264 centres in more than 25 countries including
in the US, Canada, Europe, South America and Asia.
Imfinzi
Imfinzi (durvalumab)
is a human monoclonal antibody that binds to the PD-L1 protein and
blocks the interaction of PD-L1 with the PD-1 and CD80 proteins,
countering the tumour's immune-evading tactics and releasing the
inhibition of immune responses.
In addition to its indications in resectable, early-stage
(IIA-IIIB) NSCLC and unresectable, Stage III
NSCLC, Imfinzi is also approved for use in combination
with a short course of Imjudo (tremelimumab) and chemotherapy for the
treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage SCLC in
patients whose disease has not progressed following concurrent
platinum-based CRT; and in combination with chemotherapy (etoposide
and either carboplatin or cisplatin) for the treatment of
extensive-stage SCLC.
Imfinzi is also approved
in combination with chemotherapy (gemcitabine plus cisplatin) in
locally advanced or metastatic biliary tract cancer and in
combination with Imjudo in unresectable hepatocellular carcinoma
(HCC). Imfinzi is also approved as a monotherapy in
unresectable HCC in Japan and the EU.
In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy met
the primary endpoint of EFS in the MATTERHORN Phase III trial in
resectable gastric and gastroesophageal junction
cancers.
Imfinzi is
also approved as a perioperative treatment in combination with
neoadjuvant chemotherapy for muscle-invasive bladder cancer in the
US.
Imfinzi in combination
with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line
treatment for primary advanced or recurrent endometrial cancer
(mismatch repair deficient disease only in US and
EU). Imfinzi in combination with chemotherapy followed
by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch
repair proficient advanced or recurrent endometrial cancer in EU
and Japan.
Since the first approval in May 2017, more than 374,000 patients
have been treated with Imfinzi. As part of a broad development
programme, Imfinzi is being tested as a single treatment and in
combinations with other anti-cancer treatments for patients with
SCLC, NSCLC, bladder cancer, breast cancer, several
gastrointestinal and gynaecologic cancers, and other solid
tumours.
AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer to
cure through the detection and treatment of early-stage disease,
while also pushing the boundaries of science to improve outcomes in
the resistant and advanced settings. By defining new therapeutic
targets and investigating innovative approaches, the Company aims
to match medicines to the patients who can benefit
most.
The Company's comprehensive portfolio includes leading lung cancer
medicines and the next wave of innovations,
including Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi and Imjudo; Enhertu (trastuzumab deruxtecan)
and Datroway (datopotamab deruxtecan) in collaboration
with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with
HUTCHMED; as well as a pipeline of potential new medicines and
combinations across diverse mechanisms of
action.
AstraZeneca is a founding member of the Lung Ambition Alliance, a
global coalition working to accelerate innovation and deliver
meaningful improvements for people with lung cancer, including and
beyond treatment.
AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of
immunotherapy into dedicated clinical areas of high unmet medical
need. The Company has a comprehensive and diverse IO portfolio and
pipeline anchored in immunotherapies designed to overcome evasion
of the anti-tumour immune response and stimulate the body's immune
system to attack tumours.
AstraZeneca strives to redefine cancer care and help transform
outcomes for patients with Imfinzi as a monotherapy and in combination
with Imjudo as well as other novel immunotherapies and
modalities. The Company is also investigating next-generation
immunotherapies like bispecific antibodies and therapeutics that
harness different aspects of immunity to target cancer, including
cell therapy and T-cell engagers.
AstraZeneca is pursuing an innovative clinical strategy to bring
IO-based therapies that deliver long-term survival to new settings
across a wide range of cancer types. The Company is focused on
exploring novel combination approaches to help prevent treatment
resistance and drive longer immune responses. With an extensive
clinical programme, the Company also champions the use of IO
treatment in earlier disease stages, where there is the greatest
potential for cure.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition
to provide cures for cancer in every form, following the science to
understand cancer and all its complexities to discover, develop and
deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers. It
is through persistent innovation that AstraZeneca has built one of
the most diverse portfolios and pipelines in the industry, with the
potential to catalyse changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
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 contacts, click here.
References
1. Ferlay J, et al. Cancer incidence and mortality
patterns in Europe: Estimates for 40 countries and 25 major cancers
in 2018. Eur J
Cancer.
2018;103:356-387.
2. Cagle PT, et al. Lung Cancer
Biomarkers: Present Status and Future
Developments. Arch Pathol
Lab Med.
2013;137(9):1191-1198.
3. Le Chevalier T. Adjuvant
Chemotherapy for Resectable Non-Small-Cell Lung Cancer: Where is it
Going? Ann
Oncol.
2010;21(suppl 7):vii196-198.
4. Goldstraw P, et al. The IASLC
Lung Cancer Staging Project: proposals for the revision of the TNM
stage groupings in the forthcoming (seventh) edition of the TNM
Classification of malignant tumours. J Thorac
Oncol.
2007;2(8):706-14.
5. Pignon JP, et al. Lung Adjuvant
Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative
Group. J Clin
Oncol.
2008;26(21):3552-3559.
6. World Health Organization.
International Agency for Research on Cancer. Lung Fact Sheet.
Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf.
Accessed April 2025.
7. World Health Organization.
International Agency for Research on Cancer. All Cancers Fact
Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/39-all-cancers-fact-sheet.pdf.
Accessed April 2025.
8. LUNGevity Foundation. Types of
Lung Cancer. Available at: https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed April 2025.
9. Cheema PK, et al. Perspectives on
treatment advances for stage III locally advanced unresectable
non-small-cell lung cancer. Curr
Oncol.
2019;26(1):37-42.
10. AstraZeneca PLC. Investor
Relations Epidemiology Spreadsheet. Available
at: https://www.astrazeneca.com/investor-relations.html.
Accessed April 2025.
11. Sethi S, et al. Incidental Nodule
Management - Should There Be a Formal
Process? J Thorac
Dis.
2016:8(Suppl 6);S494-S497.
12. LUNGevity Foundation. Screening
and Early Detection. Available at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection.
Accessed April 2025.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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:
04 April 2025
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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