Blueprint
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
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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reports under cover of Form 20-F or Form 40-F.
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Exchange Act of 1934.
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assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
EMA approves AZ's
Imfinzi for Stage III NSCLC
24 September 2018 16:10 BST
European Commission
approves Imfinzi
for locally-advanced, unresectable NSCLC
Phase III PACIFIC trial demonstrated compelling overall
survival
benefit and progression-free survival of more than 11
months
Imfinzi is the only immunotherapy medicine approved
for
the treatment of locally-advanced, unresectable NSCLC
AstraZeneca and MedImmune, its global biologics research and
development arm, today announced that the European Commission has
granted marketing authorisation for Imfinzi (durvalumab) as monotherapy for the
treatment of locally-advanced, unresectable non-small cell lung
cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1%
of tumour cells and whose disease has not progressed following
platinum-based chemotherapy and radiation therapy (CRT). The
approval is based on results from the Phase III PACIFIC
trial.
Dave Fredrickson, Executive Vice President, Head of the Oncology
Business, said: "Patients in Europe diagnosed with
locally-advanced, unresectable non-small cell lung cancer now have
a new treatment option. Imfinzi is the only immunotherapy to be approved in
this curative-intent setting, and we are proud to bring a new
standard of care for this difficult disease."
Dr. Luis Paz-Ares, co-principal investigator of the PACIFIC trial,
from the Hospital Universitario Doce de Octubre, Madrid, Spain,
said: "Lung cancer is the leading cause of cancer-related death in
Europe and approximately a third of European patients with NSCLC
present with locally-advanced disease. For decades, the standard of
care for these patients has been chemotherapy and radiation therapy
followed by active surveillance, after which the majority of
patients progress to advanced disease. Imfinzi has demonstrated a compelling survival
benefit for these patients in this area of significant unmet
need."
The approval follows the positive
opinion on 27 July 2018
from the CHMP of the European Medicines Agency.
The most common adverse reactions (greater than or equal to 20% of
patients) of Imfinzi versus placebo were cough (40.2% vs.
30.3%), upper respiratory tract infections (26.1% vs 11.5%)
and rash (21.7% vs 12.0%). 12.8% of patients experienced a
grade 3 or 4 AE with Imfinzi vs 9.8% with placebo.
Imfinzi is approved for
the treatment of patients with unresectable, Stage III
(locally-advanced) NSCLC in the US, Canada, Switzerland,
India, Japan and Brazil. Other global health authority reviews
and submissions are ongoing.
About Stage III NSCLC
Stage III (locally-advanced) NSCLC is divided into three
sub-categories (IIIA, IIIB and IIIC), defined by how much the
cancer has spread locally and the possibility of surgery. Stage III
disease is different from Stage IV disease, when the cancer has
spread (metastasised) to distant organs, as Stage III is currently
treated with curative intent.
Stage III NSCLC represents approximately one-third of NSCLC
incidence and was estimated to affect around 105,000 patients in
the top-eight countries (China, France, Germany, Italy, Japan,
Spain, UK, US) in 2017. The majority of Stage III NSCLC patients
are diagnosed with unresectable tumours. No new treatments beyond
chemoradiation therapy, followed by active surveillance to monitor
for progression, have been available to patients for
decades.
About PACIFIC
The PACIFIC trial is a Phase III, randomised, double-blinded,
placebo-controlled, multi-centre trial of Imfinzias treatment in 'all-comer' patients (i.e.
regardless of PD-L1 status) with unresectable, Stage III
(locally-advanced) NSCLC whose disease has not progressed following
platinum-based chemotherapy and radiation therapy
(CRT).
The trial is being conducted in 235 centres across 26 countries
involving 713 patients. The primary endpoints of the trial are PFS
and OS, and secondary endpoints include landmark PFS and OS,
objective response rate, and duration of response.
About Imfinzi
Imfinzi (durvalumab) is a
human monoclonal antibody that binds to PD-L1 and blocks the
interaction of PD-L1 with PD-1 and CD80, countering the tumour's
immune-evading tactics and releasing the inhibition of immune
responses.
Imfinzi is approved for
unresectable, Stage III NSCLC in the US, Canada, Switzerland,
India, Japan, and Brazil based on the Phase III PACIFIC
trial. Imfinzi is also approved for the treatment of
patients with locally-advanced or metastatic urothelial carcinoma
in the US, Canada, Brazil, Israel, Hong Kong, and
India.
As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in
combination with chemotherapy, radiation therapy, small molecules,
and tremelimumab, an anti-CTLA4 monoclonal antibody, as a first or
second-line treatment for patients with NSCLC, small-cell lung
cancer, locally-advanced or metastatic urothelial carcinoma, head
and neck cancer and other solid tumours.
About AstraZeneca in Lung Cancer
Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-third of all cancer
deaths.
AstraZeneca has a comprehensive portfolio of approved and potential
new medicines in late-stage clinical development for the treatment
of different forms of lung cancer across all stages of disease and
lines of therapy. We aim to address the unmet needs of patients
with EGFR-mutated tumours as a genetic driver of disease, which
occur in 10-15% of NSCLC patients in the US and EU and 30-40% of
NSCLC patients in Asia, with our approved
medicines Iressa and Tagrisso and ongoing FLAURA, ADAURA and LAURA Phase
III trials. Our extensive late-stage immuno-oncology programme
focuses on 75-80% of patients with lung cancer without a known
genetic mutation. Imfinzi, an anti-PDL1 antibody is in development as
monotherapy (ADJUVANT BR.31, PACIFIC2, MYSTIC and PEARL Phase III
trials) and in combination with tremelimumab and/or chemotherapy
(MYSTIC, NEPTUNE, POSEIDON and CASPIAN Phase III
trials).
About AstraZeneca's Approach to Immuno-Oncology (IO)
Immuno-Oncology (IO) is a therapeutic approach designed to
stimulate the body's immune system to attack tumours. At
AstraZeneca and MedImmune, our biologics research and development
arm, our IO portfolio is anchored by immunotherapies that have been
designed to overcome anti-tumour immune suppression. We believe
that IO-based therapies will offer the potential for life-changing
cancer treatments for the clear majority of patients.
We are pursuing a comprehensive clinical trial programme that
includes Imfinzi (anti-PDL1) as monotherapy and in
combination with tremelimumab (anti-CTLA4) in multiple tumour
types, stages of disease, and lines of therapy, using the PD-L1
biomarker as a decision-making tool to define the best potential
treatment path for a patient. In addition, the ability to combine
our IO portfolio with small, targeted molecules from across our
Oncology pipeline, and with those of our research partners, may
provide new treatment options across a broad range of
tumours.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a
quickly-growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With at
least six new medicines to be launched between 2014 and 2020, and a
broad pipeline of small molecules and biologics in development, we
are committed to advancing Oncology as a growth driver for
AstraZeneca, focused on lung, ovarian, breast and blood cancers. In
addition to our core capabilities, we actively pursue innovative
partnerships and investments that accelerate the delivery of our
strategy as illustrated by our investment in Acerta Pharma in
haematology.
By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment and, one day, eliminate cancer as a cause
of death.
About MedImmune
MedImmune is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
small-molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology; Respiratory; Cardiovascular, Renal & Metabolic
Diseases; and Infection and Vaccines. The MedImmune headquarters is
located in Gaithersburg, MD, one of AstraZeneca's three global
R&D centres, with additional sites in Cambridge, UK, and
Mountain View, CA. For more information, please
visit www.medimmune.com.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide.
For more information, please visit www.astrazeneca.com and
follow us on Twitter @AstraZeneca.
CONTACTS
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Media Relations
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Karen
Birmingham
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UK/Global
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+44 203 749 5634
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Rob
Skelding
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UK/Global
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+44 203 749 5821
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Matt
Kent
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UK/Global
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+44 203 749 5906
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Gonzalo
Viña
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UK/Global
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+44 203 749 5916
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Jacob
Lund
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Sweden
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+46 8 553 260 20
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Michele
Meixell
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US
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+1 302 885 2677
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Investor Relations
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Thomas Kudsk
Larsen
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+44 203 749 5712
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Henry
Wheeler
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Oncology
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+44 203 749 5797
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Christer
Gruvris
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Cardiovascular; Metabolism
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+44 203 749 5711
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Nick
Stone
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Respiratory; Renal
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+44 203 749 5716
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Josie
Afolabi
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Other
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+44 203 749 5631
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Craig
Marks
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Finance; Fixed Income
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+44 7881 615 764
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Jennifer
Kretzmann
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Retail Investors
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+44 203 749 5824
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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:
24 September
2018
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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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