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 March 2025
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi approved in EU for limited-stage SCLC
17 March 2025
Imfinzi approved
in the EU as first and only immunotherapy
for limited-stage small cell lung cancer
Approval based on ADRIATIC Phase III trial results which
showed a 27% reduction in the risk of death versus
placebo
AstraZeneca's Imfinzi (durvalumab) has been approved in the
European Union (EU) as monotherapy for the treatment of adults with
limited-stage small cell lung cancer (LS-SCLC) whose disease has
not progressed following platinum-based chemoradiation therapy
(CRT).
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 ADRIATIC Phase
III trial, which were published in The
New England Journal of Medicine.
SCLC is a highly aggressive form of lung cancer, with an estimated
8,000 people treated for LS-SCLC across the five major European
countries each year.1-2 LS-SCLC
typically recurs and progresses rapidly, despite initial response
to standard-of-care chemotherapy and
radiotherapy.3-4 The
prognosis for LS-SCLC is particularly poor, as only 15-30% of
patients survive for five years after diagnosis.5
Suresh Senan, PhD, radiation oncologist at the Amsterdam University
Medical Centers, The Netherlands, and principal investigator in the
trial, said: "This approval marks a turning point for patients with
limited-stage small cell lung cancer in Europe, bringing them an
immunotherapy option for the first time. An unprecedented 57% of
patients treated with durvalumab were still alive at three years in
the ADRIATIC trial. This significant advance establishes a new
benchmark in a setting where the standard of care has remained
unchanged for decades."
Dave Fredrickson, Executive Vice President, Oncology Haematology
Business Unit, AstraZeneca, said: "Imfinzi has the potential to transform how
limited-stage small cell lung cancer is treated as the first
immunotherapy approved in Europe in this setting. As the only
immunotherapy approved for both early and late-stage
disease, Imfinzi is poised to become the foundation for
transforming outcomes for people with small cell lung
cancer."
In the trial, results showed Imfinzi reduced the risk of death by 27% versus
placebo (based on an overall survival [OS] hazard ratio [HR] of
0.73; 95% confidence interval [CI] 0.57-0.93; p=0.0104). Estimated
median OS was 55.9 months for Imfinzi versus 33.4 months for placebo. An estimated
57% of patients treated with Imfinzi were alive at three years compared to 48%
for placebo.
Imfinzi also reduced the
risk of disease progression or death by 24% (based on a
progression-free survival [PFS] HR of 0.76; 95% CI 0.61-0.95;
p=0.0161) versus placebo. Median PFS was 16.6 months
for Imfinzi versus 9.2 months for placebo. An estimated
46% of patients treated with Imfinzi had not experienced disease progression at
two years compared to 34% for placebo.
The safety profile for Imfinzi was generally manageable and consistent with
the known profile of this medicine. No new safety signals were
observed.
Imfinzi is
approved in the US and several other countries in this setting
based on the ADRIATIC results. Regulatory applications are
currently under review in Japan and several other countries for
this indication. Imfinzi is
also approved in combination with chemotherapy for the treatment of
extensive-stage SCLC based on the CASPIAN Phase III
trial.
Notes
Small cell 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 non-small cell lung cancer (NSCLC) and
SCLC, with about 15% of cases classified as
SCLC.8
LS-SCLC (Stage I-III) accounts for approximately 30% of SCLC
diagnoses and is classified when the disease is generally only in
one lung or one side of the chest.9 The
prognosis for patients with LS-SCLC remains poor despite
curative-intent treatment with standard-of-care concurrent CRT
(cCRT).10
ADRIATIC
The ADRIATIC trial is a randomised, double-blind,
placebo-controlled, multi-centre global Phase III trial
evaluating Imfinzi monotherapy and Imfinzi plus Imjudo (tremelimumab) versus placebo in the
treatment of 730 patients with LS-SCLC who had not progressed
following cCRT. In the experimental arms, patients were randomised
to receive a 1500mg fixed dose of Imfinzi with or without Imjudo 75mg every four weeks for up to four
doses/cycles each, followed by Imfinzi every four weeks for up to 24
months.
The dual primary endpoints were PFS and OS
for Imfinzi monotherapy versus placebo. Key secondary
endpoints included OS and PFS for Imfinzi plus Imjudo versus placebo, safety and quality of life
measures. The trial included 164 centres in 19 countries across
North and South America, Europe 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 SCLC, Imfinzi is also the global standard of care based on
OS in the curative-intent setting of unresectable, Stage III NSCLC
in patients whose disease has not progressed after CRT.
Additionally, Imfinzi is approved as a perioperative treatment in
combination with neoadjuvant chemotherapy in resectable NSCLC; and
in combination with a short course of Imjudo and chemotherapy for the treatment of
metastatic NSCLC.
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 event-free survival in the MATTERHORN Phase
III trial in resectable gastric and gastroesophageal junction
cancers.
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. National Cancer Institute. NCI Dictionary - Small
Cell Lung Cancer. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer.
Accessed March 2025.
2. AstraZeneca PLC. Investor
Relations Epidemiology Spreadsheet. Available
at: https://www.astrazeneca.com/investor-relations.html.
Accessed March 2025.
3. Qin A, Kalemkerian GP. Treatment
Options for Relapsed Small-Cell Lung Cancer: What Progress Have We
Made? J Oncol
Pract.
2018;14(6):369-370.
4. Cheng Y, et al. Durvalumab after
Chemoradiotherapy in Limited-Stage Small-Cell Lung
Cancer. N Engl J
Med.
2024;391(14):1313-1327.
5. Bebb DG, et al. Symptoms and
Experiences with Small Cell Lung Cancer: A Mixed Methods Study of
Patients and Caregivers. Pulm
Ther.
2023;9:435-450.
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 March 2025.
7. World Health Organization.
International Agency for Research on Cancer. World Fact Sheet.
Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf.
Accessed March 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 March 2025.
9. American Cancer Society. Small
Cell Lung Cancer Stages. Available at: https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/staging-sclc.html.
Accessed March 2025.
10. Senan S, et al. ADRIATIC: A phase
III trial of durvalumab ± tremelimumab after concurrent
chemoradiation for patients with limited stage small cell lung
cancer. Ann
Oncol.
2019;30(suppl. 2):ii25.
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:
17 March 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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