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 (July 2018)
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. CHMP recommends Imfnizi for Stage III nsclc
This announcement contains inside information
27 July 2018 14:00 BST
Imfinzi receives positive
EU CHMP opinion for locally-
advanced, unresectable non-small cell lung cancer
Recommended marketing authorisation for patients
whose tumours express PD-L1 on ≥1% of tumour
cells
Imfinzi is the first immunotherapy recommended for
approval
for the treatment of locally-advanced, unresectable
NSCLC
AstraZeneca
and MedImmune, its global biologics research and development arm,
today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency has adopted a positive
opinion, recommending a marketing authorisation
of Imfinzi (durvalumab)
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 recommendation is based on the progression-free survival (PFS)
and overall survival (OS) primary endpoints of the Phase III
PACIFIC trial, and post-hoc subgroup analyses by PD-L1 expression
requested by the CHMP.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "The CHMP positive
opinion brings European patients closer to having a treatment
following chemoradiation therapy. There have been no new treatments
in this setting for decades. With approximately a third of European
non-small cell lung cancer patients presenting with this stage of
disease, we are excited by this potential new standard of care in
this curative-intent setting."
In the
PACIFIC trial, Imfinzi
demonstrated a statistically-significant and clinically-meaningful
improvement in PFS and OS in "all-comer" patients. The recommended
label reflects most of the patients in the trial with a known PD-L1
status.
Overall
survival results from the PACIFIC trial will be presented at a
forthcoming medical meeting.
The
positive opinion from the CHMP will now be reviewed by the European
Commission, which has the authority to approve medicines for the 28
European Union member countries plus Iceland, Norway and
Liechtenstein. Earlier this year, Imfinzi was approved for
unresectable, Stage III NSCLC in the US, Canada, Switzerland,
India, Japan and Brazil based on the Phase III PACIFIC trial. In
addition to the EU, other global health authority reviews and
submissions are ongoing.
About Stage III NSCLC
Stage
III (locally advanced) NSCLC is commonly 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 randomised, double-blinded, placebo-controlled,
multi-centre trial of Imfinzi as treatment in 'all-comer'
patients (i.e. regardless of PD-L1 status) with unresectable, Stage
III 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, and Japan based on the Phase III
PACIFIC trial.
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. The portfolio includes Imfinzi, an anti-PDL1 antibody, which
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.
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Adrian Kemp
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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:
27 July
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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