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 December
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.
Update
on the Phase III EAGLE trial of Imfinzi
7
December 2018 07:00 GMT
Update on the Phase III EAGLE trial of Imfinzi and
tremelimumab in advanced head and neck cancer
AstraZeneca and MedImmune, its global biologics research and
development arm, today announced overall survival (OS) results for
the Phase III EAGLE trial. EAGLE is a randomised, open-label,
multi-centre trial evaluating Imfinzi (durvalumab)
monotherapy or Imfinzi in combination with tremelimumab, an
anti-CTLA4 antibody, versus standard-of-care
(SoC) chemotherapy in
patients with recurrent or metastatic head and neck squamous cell
carcinoma (HNSCC) who experienced disease progression following
platinum-based chemotherapy, regardless of their PD-L1 tumour
status.
Imfinzi monotherapy and
the combination of Imfinzi plus tremelimumab did not meet the primary
endpoints of improving OS compared to SoC chemotherapy in these
hard-to-treat patients. The safety and tolerability profiles
for Imfinzi and the combination with tremelimumab were
consistent with previous experience.
Sean Bohen, Executive Vice President, Global Medicines Development
and Chief Medical Officer, said: "The prognosis for recurrent or
metastatic head and neck squamous cell cancer is very poor and new
treatments for this group of cancers are urgently needed. While
these results are disappointing, we remain committed to evaluating
the potential of Imfinzi and other innovative medicines for patients
with head and neck cancer. We look forward to seeing the results of
the Phase III KESTREL trial of Imfinzi and tremelimumab in patients who have not
received prior chemotherapy for recurrent or metastatic head and
neck squamous cell carcinoma in the first half of
2019."
AstraZeneca will submit the results from the Phase III EAGLE trial
for presentation at a forthcoming medical meeting.
About EAGLE
The EAGLE trial is a randomised, open-label, multi-centre, global,
Phase III trial of Imfinzi (durvalumab) monotherapy
or Imfinzi in combination with tremelimumab compared to
standard-of-care chemotherapy in patients with recurrent or
metastatic HNSCC who experienced progression following
platinum-based chemotherapy, regardless of their PD-L1 tumour
status.
The trial was conducted at 169 centres across 24 countries
including the US, Europe, South America, Japan, Korea, Taiwan,
Israel and Australia. The primary endpoint of the trial was OS, and
secondary endpoints included progression-free survival, landmark
OS, objective response rate and duration of response.
About HNSCC
Approximately 880,000 patients were diagnosed with head and neck
cancer around the world in 2018. Two-thirds of patients diagnosed
with head and neck cancer are in advanced stages (Stage III or IV),
while the remaining one third are in the early stages of disease
(Stage I or II). More than 90% of all head and neck cancers start
in the squamous cells that line the mouth, nose and throat called
head and neck squamous cell carcinomas (HNSCC).
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 non-small cell lung cancer (NSCLC) in more
than 40 countries including the US, EU, and Japan based on the
Phase III PACIFIC trial. Imfinzi is also approved for previously-treated
patients with advanced bladder cancer in the US, Canada, Brazil,
Israel, India, United Arab Emirates, Australia and Hong
Kong.
As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in
combination with tremelimumab, an anti-CTLA4 monoclonal antibody
and potential new medicine, as a treatment for patients with NSCLC,
small-cell lung cancer (SCLC), bladder cancer, head and neck cancer
and other solid tumours.
About tremelimumab
Tremelimumab is a human monoclonal antibody and potential new
medicine 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 a
clinical trial programme in combination
with Imfinzi in NSCLC, SCLC, bladder cancer, head and
neck squamous cell carcinoma, liver cancer and blood
cancers.
About AstraZeneca's approach to 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
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 from 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 key 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. 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:
07 December
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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