a0812k
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 December 2022
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 PEARL Phase III trial of Imfinzi
monotherapy in Stage IV non-small cell lung cancer
19 December 2022 07:05 GMT
Update on PEARL Phase III trial
of Imfinzi monotherapy
in Stage IV non-small cell lung cancer
The PEARL Phase III trial for
AstraZeneca's Imfinzi (durvalumab)
did not achieve statistical significance for the primary endpoints
of improving overall survival (OS) versus platinum-based
chemotherapy as a monotherapy treatment of patients with Stage IV
(metastatic) non-small cell lung cancer (NSCLC) whose tumour cells
express high levels (25% or more) of PD-L1, or in a subgroup of
patients at low risk of early mortality. There was an improvement
in OS with Imfinzi monotherapy, which was clinically meaningful
in the subset of patients with PD-L1 tumour expression greater than
50%, a secondary endpoint. The trial was conducted primarily in
Asia.
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "With PEARL, we set out to answer important
scientific questions in the treatment of metastatic non-small cell
lung cancer at a time when patient selection for immune checkpoint
inhibitors was still evolving. We are encouraged to see patients in
the metastatic setting at a higher level of PD-L1 tumour expression
demonstrate the most benefit with Imfinzi monotherapy treatment, as is commonly seen
in this class. We remain steadfast in our dedication to developing
new and improved medicines and regimens for patients with lung
cancer across our diverse portfolio."
The safety and tolerability profile for Imfinzi was broadly consistent with the known
profile of the medicine, and no new safety signals were
identified. The data will be shared in due
course.
Notes
Stage IV NSCLC
Lung cancer is the second most common form of cancer globally, with
more than two million patients diagnosed in
2020.1 Lung
cancer is broadly split into NSCLC and small-cell lung cancer
(SCLC), with 80-85% classified as NSCLC.2,3 Within
NSCLC, patients are classified as squamous, representing 25-30% of
patients, or non-squamous, representing approximately 70-75% of
patients.3-5
PEARL
PEARL was a randomised, open-label, multicentre, global Phase III
trial of Imfinzi monotherapy versus platinum-based
chemotherapy (investigator's choice) as a 1st-line treatment in
patients with metastatic NSCLC.
Eligible patients had tumours expressing high levels of PD-L1,
defined as ≥25% of tumour cells (TC). The predominantly Asian
trial population included both smokers and non-smokers and patients
of squamous and non-squamous histology. PEARL excluded patients
with certain epidermal growth factor receptor (EGFR) mutations or
anaplastic lymphoma kinase (ALK) fusions.
The two primary endpoints were OS in patients whose tumours
expressed high levels of PD-L1 (TC≥25%) and OS in a subgroup
of patients identified
as being at
low risk of early mortality using
a model developed by AstraZeneca that evaluates various clinical
parameters prior to treatment. The
trial included centres in Asia, Europe and
Australia.
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.
Imfinzi in
combination with Imjudo (tremelimumab) plus platinum-based
chemotherapy is approved in the US for the treatment of Stage IV
(metastatic) NSCLC based on the POSEIDON Phase III trial.
Additionally, Imfinzi is the only approved immunotherapy and the
global standard of care in the curative-intent setting of
unresectable, Stage III NSCLC in patients whose disease has not
progressed after chemoradiation therapy based on the PACIFIC Phase
III trial. Imfinzi is also approved in the US, the EU, Japan,
China and many other countries around the world for the treatment
of extensive-stage small cell lung cancer based on the CASPIAN
Phase III trial.
In addition to its approved indications in lung
cancer, Imfinzi is the only approved immunotherapy in
unresectable or metastatic biliary tract cancer and is also
approved in unresectable hepatocellular carcinoma in combination
with Imjudo. It is also approved for previously treated
patients with advanced bladder cancer in several
countries.
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, several gastrointestinal cancers,
ovarian cancer, endometrial cancer, 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 (durvalumab) and Imjudo (tremelimumab); 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 aims to reimagine cancer care and help transform
outcomes for patients with Imfinzi as
a single treatment and in combination
with Imjudo as
well as other novel immunotherapies and modalities. The Company is
also exploring next-generation immunotherapies like bispecific
antibodies and therapeutics that harness different aspects of
immunity to target cancer.
AstraZeneca is boldly 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. 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 Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. WHO. International
Agency of Cancer Research. Lung Fact Sheet. Available
at: https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed December 2022.
2. 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.
3. Abernethy
AP, et
al. Real-world first-line
treatment and overall survival in non-small cell lung cancer
without known EGFR mutations or ALK rearrangements in US community
oncology setting. PLoS ONE. 2017;12(6):e0178420.
4. 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.
5. Cancer.net. Lung
Cancer - Non-Small Cell: Introduction. Available
at: https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/introduction. Accessed
December 2022.
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:
19 December 2022
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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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