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 April 2018
Commission
File Number: 001-11960
AstraZeneca PLC
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Francis Crick Avenue
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca:high
level results of the ARCTIC trial
24
April 2018 07:00 BST
ASTRAZENECA REPORTS RESULTS FROM THE ARCTIC
TRIAL IN THIRD-LINE NON-SMALL CELL LUNG CANCER
AstraZeneca
and MedImmune, its global biologics research and development arm,
today announced high-level results from the Phase III ARCTIC trial
in patients with locally-advanced or metastatic non-small cell lung
cancer (NSCLC) who have received at least two prior treatments.
This randomised, open-label, multi-centre trial assessed the
efficacy and safety of the combination of Imfinzi (durvalumab) plus tremelimumab,
as well as Imfinzi and
tremelimumab monotherapies, versus standard-of-care chemotherapy
(SoC) in patients with PDL1-low/negative NSCLC (sub-study
B), and Imfinzi monotherapy versus SoC in
patients with PDL1-high NSCLC (sub-study A).
In
sub-study B, the combination of Imfinzi plus tremelimumab in patients
with PD-L1 low/negative NSCLC did not meet the primary endpoints of
a statistically-significant and clinically-meaningful improvement
in progression-free survival (PFS) and overall survival (OS)
compared to SoC. Activity and safety of monotherapy arms of
sub-study B were consistent with prior published data.
Sub-study
A was not powered for statistical significance; however,
Imfinzi monotherapy showed
a clinically-meaningful reduction in the risk of death compared to
chemotherapy.
Full
data from the ARCTIC trial will be presented at a forthcoming
medical meeting.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer, said: "While we are disappointed that the
combination of Imfinzi plus
tremelimumab did not result in a statistically-significant survival
benefit in this heavily pre-treated patient population, we are
encouraged by the activity of Imfinzi monotherapy observed in this
trial and look forward to presenting the full data from the ARCTIC
trial at an upcoming medical meeting."
AstraZeneca recently received approval from the US FDA for
Imfinzi
for the treatment of patients with
unresectable, Stage III NSCLC whose disease has not progressed
following concurrent platinum-based chemotherapy and radiation
therapy.
About ARCTIC
The
ARCTIC trial was a randomised, open-label, multi-centre, global
Phase III trial containing two sub-studies: sub-study A (1:1
randomisation of patients with PDL1-high tumours to Imfinzi (durvalumab) vs. SoC) and
sub-study B (2:3:1:2 randomisation of patients with
PDL1-low/negative tumours to Imfinzi monotherapy, Imfinzi plus tremelimumab or
tremelimumab vs SoC). Tumour PD-L1 expression was assessed with the
Ventana PD-L1 (SP263) assay with PD-L1 high defined as ≥25%
of tumour cells with membrane staining.
About Imfinzi
Imfinzi 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.
In
February 2018, Imfinzi
received US FDA approval for the treatment of patients with
unresectable, Stage III NSCLC whose disease has not progressed
following concurrent platinum-based chemotherapy and radiation
therapy. Imfinzi also
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 tested as a
monotherapy and in combination with tremelimumab, an anti-CTLA-4
monoclonal antibody and potential new medicine, as a first-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 tremelimumab
Tremelimumab
is a human monoclonal antibody and potential new medicines that
targets the activity of cytotoxic T-lymphocyte-associated protein 4
(CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing
to T cell activation and boosting the immune response to cancer.
Tremelimumab is being tested in an extensive clinical-trial
programme in combination with Imfinzi in NSCLC, locally-advanced or
metastatic urothelial carcinoma, head and neck cancer, liver cancer
and blood cancers.
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 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 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, an anti-PDL1 antibody, which
is in development as monotherapy (ADJUVANT, PACIFIC, MYSTIC, PEARL
and ARCTIC trials) and in combination with tremelimumab (MYSTIC,
NEPTUNE, ARCTIC and POSEIDON trials).
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
Imfinzi (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 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. 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:
24 April
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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