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 May 2017
Commission
File Number: 001-11960
AstraZeneca PLC
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12g3-2(b): 82-_____________
This announcement contains inside information
12 May
2017 07:00 BST
IMFINZI SIGNIFICANTLY
REDUCES THE RISK OF DISEASE WORSENING OR DEATH IN THE PHASE III
PACIFIC TRIAL FOR STAGE III UNRESECTABLE LUNG CANCER
Imfinzi met a primary endpoint of statistically-significant and
clinically-meaningful progression-free survival (PFS) in
'all-comer' patients with locally-advanced, unresectable (Stage
III) non-small cell lung cancer in a planned interim
analysis
Imfinzi is the first immuno-oncology medicine to show superior PFS
in this setting
Plans for regulatory submission under active discussion with
authorities
AstraZeneca
and MedImmune, its
global biologics research and development arm, today
announced positive results for the Phase III PACIFIC trial, a
randomised, double-blinded, placebo-controlled multi-centre trial
of Imfinzi (durvalumab) as
sequential treatment in patients with locally-advanced,
unresectable (Stage III) non-small cell lung cancer
(NSCLC) who had not progressed following standard
platinum-based chemotherapy concurrent with radiation
therapy.
A
planned interim analysis conducted by an Independent Data
Monitoring Committee (IDMC) concluded that the trial has already
met a primary endpoint by showing statistically-significant and
clinically-meaningful PFS, as assessed by blinded independent
central review, in patients receiving Imfinzi compared to placebo. The
results also demonstrate a favourable benefit/risk profile. The
trial will also evaluate overall survival (OS), the other primary
endpoint, which will be assessed in due course as specified by the
protocol. AstraZeneca plans to submit the initial results from the
PACIFIC trial for presentation at a forthcoming medical
meeting.
Sean Bohen, Executive Vice President, Global Medicines Development
and Chief Medical Officer at AstraZeneca, said: "These
are highly encouraging results for patients with locally-advanced
lung cancer for whom surgery is not an option. We look forward to
working with regulatory authorities around the world to bring
Imfinzi to lung cancer
patients as soon as possible. Alongside this, we continue to
explore Imfinzi's full
potential as monotherapy as well as in combination with
tremelimumab and other medicines in areas of continued unmet need
across multiple types of cancer."
Stage
III lung cancer represents approximately one third of NSCLC
incidence and was estimated to affect around 100,000 patients in
the G7 countries in 2016[i].
About half of these patients have tumours that are unresectable.
The prognosis remains poor and long-term survival rates are
low.
AstraZeneca
recently received accelerated approval from the US FDA for
Imfinzi in previously
treated patients with advanced bladder cancer. Imfinzi is also being tested in the
1st-line treatment of patients with NSCLC as monotherapy in the
MYSTIC and PEARL Phase III trials. It is also being developed in
combination with tremelimumab, a checkpoint inhibitor that targets
CTLA-4, as part of the MYSTIC, NEPTUNE and POSEIDON Phase III
trials.
About PACIFIC
The
PACIFIC trial is a randomised, double-blinded, placebo-controlled
multi-centre trial of Imfinzi as sequential treatment in
unselected patients with locally-advanced, unresectable (Stage III)
NSCLC who have not progressed following platinum-based chemotherapy
concurrent with radiation therapy.
The
trial is being conducted in 235 centres across 26 countries,
including the US, Canada, Europe, South and Central America, Japan,
Korea, Taiwan, South Africa and Australia. 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, previously known as MEDI4736), a human
monoclonal antibody directed against PD-L1, blocks PD-L1
interaction with PD-1 and CD80 on T cells, countering the tumour's
immune-evading tactics and inducing an immune
response.
Imfinzi continues to advance in multiple monotherapy trials
and combination trials with tremelimumab and other potential new
medicines in IO. Imfinzi is
being assessed in Phase III trials as a monotherapy in various
stages of NSCLC, in small-cell lung cancer (SCLC), in urothelial
bladder cancer and in head and neck squamous cell carcinoma
(HNSCC). The combination of Imfinzi and tremelimumab is being
assessed in Phase III trials in urothelial bladder cancer, NSCLC,
SCLC and HNSCC and in Phase I/II trials in gastric cancer,
pancreatic cancer, hepatocellular carcinoma and haematological
malignancies.
About AstraZeneca in NSCLC
Lung
cancer is the leading cause of cancer death among both men and
women, accounting for about one-third of all cancer deaths and more
than breast, prostate and colorectal cancers combined.
AstraZeneca
has a comprehensive portfolio of approved and potential new
medicines in late-stage clinical development for the treatment of
NSCLC across all stages of disease and lines of therapy. We aim to
address unmet needs of patients with EGFR-mutated tumours as a
genetic driver of disease, which occur in 15-20% of NSCLC patients
globally and 30-40% of NSCLC patients in Asia, with our approved
medicines Iressa and
Tagrisso and on-going
FLAURA and ADAURA trials. Our extensive late-stage immuno-oncology
programme focuses on 75-80% of patients with NSCLC without a known
genetic mutation. Our portfolio includes Imfinzi (durvalumab), an anti-PDL1
antibody, which is in development as monotherapy (ADJUVANT,
PACIFIC, MYSTIC, PEARL and ARCTIC trials) and in combination with
tremelimumab, anti-CTLA-4 (MYSTIC, NEPTUNE and POSEIDON
trials).
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 vast majority of patients.
We are
pursuing a comprehensive clinical trial programme that includes
Imfinzi (anti-PDL1)
monotherapy and in combination with tremelimumab (anti-CTLA-4) in
multiple tumour types, stages of disease, and lines of therapy, and
where relevant 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 New Oncology as one of AstraZeneca's five Growth
Platforms 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, the genetic drivers of cancer 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 commercialization 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 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 main
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
[i] Kantar, other market research based on 2016 patient
numbers; Globocan 2012. G7 countries include the US, Japan,
Germany, the UK, France, Italy and Canada.
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.
AstraZeneca
PLC
Date:
12 May 2017
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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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