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 February 2018
Commission
File Number: 001-11960
AstraZeneca PLC
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AstraZeneca PLC
INDEX
TO EXHIBITS
AstraZeneca's
IMFINZI approved for Stage III nsclc
This announcement contains inside information
19 February 2018 07:00 GMT
US FDA APPROVES IMFINZI FOR
UNRESECTABLE STAGE III NON-SMALL CELL LUNG CANCER
Imfinzi is the only immunotherapy approved for patients with
unresectable Stage III non-small cell lung cancer
Imfinzi showed an 11.2 month improvement in median progression-free
survival (16.8 months compared to 5.6 months on
placebo)
AstraZeneca
and MedImmune, its global biologics research and development arm,
today announced that the US Food and Drug Administration (FDA) has
approved Imfinzi for the
treatment of patients with unresectable Stage III non-small cell
lung cancer (NSCLC) whose disease has not progressed following
concurrent platinum-based
chemotherapy and radiation therapy (CRT).
Dave
Fredrickson, Executive Vice President, Head of the Oncology
Business Unit at AstraZeneca, said: "The approval of Imfinzi in this earlier stage of
non-small cell lung cancer is a truly meaningful milestone for
patients who, until now, had no FDA-approved treatment options
following chemoradiation therapy. Globally, approximately 30% of
patients with NSCLC present with Stage III disease and we are
excited to launch the first immunotherapy into this
setting."
Scott
J. Antonia, MD, Ph.D., Chair of the Thoracic Oncology Department at
the H. Lee Moffitt Cancer Center and Research Institute in Tampa
and investigator in the PACIFIC trial, said: "Until now, treatment
guidelines have recommended that patients with unresectable Stage
III lung cancer undergo a period of active surveillance following
chemoradiation therapy until disease progression. Given that up to
89% of patients will progress to metastatic disease, it is
important that there is now a new option that can give patients
more time without disease progression. The PACIFIC trial data
supporting today's approval of Imfinzi will change how we treat these
patients."
The
approval of Imfinzi is
based on the positive PFS data from the Phase III PACIFIC
trial
in
which Imfinzi demonstrated
an improvement in median PFS of 11.2 months compared to placebo,
representing a 48% reduction in relative risk of progression or
death vs. placebo in all patients, regardless of PD-L1 status. The
PACIFIC trial is ongoing to evaluate overall survival (OS) in
unresectable Stage III NSCLC. Detailed interim results of the
PACIFIC trial were published online in the New
England Journal of Medicine (NEJM).
|
PFS (co-primary endpoint)1
|
Imfinzi
(N=476)2
|
Placebo
(N=237)2
|
|
Number
(%) of patients with event
|
214
(45%)
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157
(66%)
|
|
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
Overall,
the incidence and severity of adverse events were comparable for
patients receiving Imfinzi
and the patients receiving placebo. In patients receiving Imfinzi, the most common adverse
reactions (greater than or equal to 20% of patients) were cough
(40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%),
upper respiratory tract infections (26%), dyspnoea (25%), and rash
(23%). Discontinuation after concurrent CRT due to adverse
reactions, regardless of causality, occurred in 15% of patients
receiving Imfinzi vs. 10%
of patients receiving placebo.
On 28
September 2017, the National Comprehensive Cancer Network (NCCN)
Clinical Practice Guidelines in Oncology were updated to include
Imfinzi for the treatment
of patients with unresectable Stage III NSCLC with no disease
progression after two or more cycles of concurrent
CRT.
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. This
differentiates it from Stage IV disease, when the cancer has spread
(metastasised) to distant organs.
Stage
III NSCLC represents approximately one-third of NSCLC incidence and
was estimated to affect around 105,000 patients in France, Germany,
Italy, Japan, Spain, the UK and the US in 2016. The majority of
Stage III NSCLC patients are diagnosed with unresectable tumours.
Until now, the current standard of care has been chemotherapy and
radiation therapy, followed by active surveillance to monitor for
progression. The prognosis remains poor and long-term survival
rates are low.
About Imfinzi
Imfinzi (durvalumab), 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 has already received accelerated approval in the US
for the treatment of patients with locally-advanced or metastatic
urothelial carcinoma, who have disease progression during or
following platinum-containing chemotherapy, or whose disease has
progressed within 12 months of receiving platinum-containing
chemotherapy before (neoadjuvant) or after (adjuvant)
surgery.
As part
of a broad development programme, Imfinzi is also being investigated for
the adjuvant treatment of patients with NSCLC in the Canadian
Cancer Trials Group BR31 trial (ADJUVANT). In the MYSTIC, NEPTUNE
and PEARL Phase III trials, Imfinzi is being studied for 1st-line
treatment as monotherapy and/or in combination with tremelimumab,
an anti-CTLA-4 monoclonal antibody and potential new medicine, for
the treatment of metastatic NSCLC. The POSEIDON trial is
investigating Imfinzi with
and without tremelimumab in combination with chemotherapy in a
similar patient population.
About AstraZeneca in Lung Cancer
AstraZeneca
is committed to developing medicines to help every patient with
lung cancer. We have three approved medicines and a growing
pipeline that targets genetic changes in tumour cells and boosts
the power of the immune response against cancer. Our unrelenting
pursuit of science aims to deliver more breakthrough therapies with
the goal of extending and improving the lives of patients across
all stages of disease and lines of therapy.
About AstraZeneca's Approach to Immuno-Oncology
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
durvalumab (anti-PD-L1) as monotherapy and in combination with
tremelimumab (anti-CTLA-4) 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 advance Oncology as a growth platform 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 & 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 & Metabolic
Diseases 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:
19 FEBRUARY
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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