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.
Imfinzi
approved in Japan for Stage III nsclc
02 July 2018 07:00 BST
Imfinzi approved in Japan for unresectable Stage III non-small cell
lung cancer
Imfinzi is the only immunotherapy approved for unresectable Stage
III NSCLC
Approval is based on the Phase III PACIFIC trial
AstraZeneca
and MedImmune, its global biologics research and development arm,
today announced that the Japanese Ministry of Health, Labour and
Welfare approved Imfinzi (durvalumab) as maintenance
therapy after definitive chemoradiation therapy (CRT) in
locally-advanced (Stage III), unresectable non-small cell lung
cancer (NSCLC).
Dave
Fredrickson, Executive Vice President, Head of the Oncology
Business Unit said: "Non-small cell lung cancer is a leading cause
of death in Japan, and we are dedicated to bringing new treatment
options to patients as quickly as possible. As the only
immunotherapy approved in the curative-intent, Stage III lung
cancer setting, Imfinzi has
the potential to change the treatment paradigm for patients
diagnosed with this disease."
The
approval of Imfinzi is
based on positive progression-free survival (PFS) data from the
Phase III PACIFIC trial in unresectable Stage III NSCLC. In the
trial, Imfinzi demonstrated
an improvement in median PFS of 11.2 months compared to placebo.
Imfinzi improved other
meaningful outcomes such as time to distant metastasis or death and
overall response rates. Detailed results of the PACIFIC trial were
published in the New
England Journal of Medicine (NEJM).
|
PFS (first primary
endpoint)1
|
Imfinzi
(N=476)2
|
Placebo
(N=237)2
|
|
Median
in months
(95%
CI)
|
16.8
(13,
18.1)
|
5.6
(4.6,
7.8)
|
|
Hazard
ratio
(95%
CI)3,
4
|
0.52
(0.42, 0.65)
|
|
p-value3,
5
|
<0.0001
|
1 Blinded Independent Central Review
(BICR).
2 Among the ITT population, 7% in the Imfinzi arm and 10% in the placebo arm
had non-measurable disease as assessed by BICR according to RECIST
v1.1.
3 Stratified by sex, age, and smoking history.
4 Pike estimator.
5 Compared with allocated a of 0.0104 (Lan DeMets spending
function approximating O'Brien Fleming boundary) for interim
analysis.
The
incidence and severity of adverse events were comparable for
patients receiving Imfinzi
vs. patients receiving placebo. The most frequent adverse reactions
were rash which occurred in 73 subjects (15.4%), hypothyroidism
which occurred in 50 subjects (10.5%), diarrhoea which occurred in
46 subjects (9.7%) and interstitial lung disease which occurred in
46 subjects (9.7%).
In May
2018, AstraZeneca announced that the PACIFIC trial met its second
primary endpoint, showing statistically-significant and
clinically-meaningful overall survival (OS) in patients
receiving Imfinzi compared to placebo. Full
results will be presented at a forthcoming medical
meeting.
Imfinzi is also approved in the US, Canada, Switzerland and
India based on the Phase III PACIFIC trial. Regulatory reviews in
the EU and other jurisdictions are ongoing with an EU decision
expected in the second half of 2018.
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. Before the PACIFIC trial, the standard of
care was chemotherapy and radiation therapy, followed by active
surveillance to monitor for progression.
About PACIFIC
The
PACIFIC trial is a randomised, double-blinded, placebo-controlled,
multi-centre trial of Imfinzi as treatment in patients with
Stage III unresectable NSCLC whose disease has not progressed
following platinum-based chemoradiation therapy (CRT).
The
trial has been 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.
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 1st-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, PACIFIC-2, MYSTIC
and PEARL trials) and in combination with tremelimumab and/or
chemotherapy (MYSTIC, NEPTUNE, CASPIAN, and POSEIDON
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 South
San Francisco, 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. The Company also is selectively active
in the areas of autoimmunity, neuroscience and infection.
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
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:
02 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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