a4121j
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 2024
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.
Imfinzi improved OS & PFS in limited-stage SCLC
05 April 2024
Imfinzi significantly
improved overall survival and progression-free survival for
patients with limited-stage small cell lung cancer in ADRIATIC
Phase III trial
First and only immunotherapy to demonstrate survival benefit in
this setting in a global Phase III trial
Positive high-level results of the ADRIATIC Phase III trial showed
AstraZeneca's Imfinzi (durvalumab)
demonstrated a statistically significant and clinically meaningful
improvement in the dual primary endpoints of overall survival (OS)
and progression-free survival (PFS) in patients with limited-stage
small cell lung cancer (LS-SCLC) who had not progressed following
concurrent chemoradiotherapy (cCRT) compared to placebo after
cCRT.
Small cell lung cancer (SCLC) is a highly aggressive form of lung
cancer that typically recurs and progresses rapidly despite initial
response to chemotherapy and radiotherapy in LS-SCLC
patients.1,2 The
prognosis is particularly poor for LS-SCLC, as
only 15-30%
of these patients will be alive five years after
diagnosis.3
Suresh Senan, PhD, Professor of Clinical
Experimental Radiotherapy at the Amsterdam University Medical
Center, The Netherlands, and principal
investigator in the trial said:
"Many patients treated for limited-stage small cell lung cancer
face disease recurrence and the standard of care has remained
unchanged for decades. ADRIATIC is the first global Phase III
immunotherapy trial to deliver significant, clinically meaningful
improvement in survival in
this setting, marking a breakthrough for patients with this
devastating disease."
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "These exciting results build on the
transformative efficacy of Imfinzi in extensive-stage small cell lung cancer
and demonstrate the potential to bring a curative-intent
immunotherapy treatment to this earlier-stage setting of small cell
lung cancer for the first time. These data, together with the
PACIFIC data in unresectable, Stage III non-small cell lung cancer,
underscore the pioneering role of Imfinzi in the treatment of early lung cancer
following chemoradiotherapy."
The safety profile for Imfinzi was consistent with its known profile, and
no new safety signals were identified.
These data will be presented at a forthcoming medical meeting and
shared with global regulatory authorities.
The second experimental arm testing the efficacy
of Imjudo (tremelimumab) added
to Imfinzi as a secondary endpoint remains blinded and
will continue to the next planned analysis.
Imfinzi is
approved in the US, EU, Japan, China and many other countries
around the world for the treatment of extensive-stage SCLC
(ES-SCLC) based on the CASPIAN Phase III trial. Imfinzi is
also the only approved immunotherapy and the global standard of
care in the curative-intent setting of unresectable, Stage
III non-small
cell lung cancer (NSCLC) in
patients whose disease has not progressed after CRT based on the
PACIFIC Phase III trial.
Notes:
Small cell lung cancer
Lung cancer is the leading cause of cancer death among men and
women and accounts for about one-fifth of all cancer
deaths.4 Lung
cancer is broadly split into NSCLC and SCLC, with about 15% of
cases classified as SCLC.5
LS-SCLC (Stage I-III) is classified as SCLC that is generally only
in one lung or one side of the chest.6 LS-SCLC
accounts for approximately 30% of SCLC diagnoses and the prognosis
remains poor despite curative-intent treatment with
standard-of-care cCRT.7
ADRIATIC
The ADRIATIC trial is a randomised, double-blind,
placebo-controlled, multi-centre global Phase III trial
evaluating Imfinzi monotherapy
and Imfinzi plus Imjudo 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 are 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 includes 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 unresectable, Stage III NSCLC and
ES-SCLC, Imfinzi is currently approved in a number of
countries in combination with a short course
of Imjudo and chemotherapy for the treatment of
metastatic NSCLC.
Imfinzi is
also approved in a number of countries in combination with
chemotherapy 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 and in previously treated patients with advanced bladder cancer
in a small number of countries.
Since the first approval in May 2017, more than 220,000 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 cancers and other solid
tumours.
Imjudo
Imjudo (tremelimumab)
is a human monoclonal antibody that targets the activity of
cytotoxic T-lymphocyte-associated protein 4
(CTLA-4). Imjudo blocks
the activity of CTLA-4, contributing to T-cell activation, priming
the immune response to cancer and fostering cancer cell
death.
In addition to its approved indications in combination
with Imfinzi in liver and lung cancers, the combination
of Imjudo and Imfinzi is being evaluated across multiple tumour
types including locoregional HCC (EMERALD-3) and bladder cancer
(VOLGA and NILE).
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 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 operates in over
100 countries and its innovative medicines are 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 April
2024.
2. Qin A and Kalemkerian GP. Treatment
Options for Relapsed Small-Cell Lung Cancer: What Progress Have We
Made? J Oncol
Pract.
2018;14(6):369-370.
3. 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.
4. 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 2024.
5. LUNGevity
Foundation. Types of Lung Cancer. Available at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed April 2024.
6. American
Cancer Society. Treatment Choices by Stage for Small Cell Lung
Cancer. Available at: https://www.cancer.org/cancer/lung-cancer/treating-small-cell/by-stage.html. Accessed April
2024.
7. 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.
Date:
5 April 2024
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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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