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 March
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
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as permitted by Regulation S-T Rule 101(b)(1):
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as permitted by Regulation S-T Rule 101(b)(7): ______
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by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
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82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
ASTRAZENECA UPDATES
MYSTIC TRIAL TIMELINE
12 March 2018 07:00 GMT
ASTRAZENECA PROVIDES UPDATE ON MYSTIC TRIAL TIMELINE
AstraZeneca
and MedImmune, its global biologics research and development arm,
today announced an updated timeline for the final analysis of the
Phase III MYSTIC trial of Imfinzi (durvalumab) as monotherapy and
in combination with tremelimumab, versus platinum-based
standard-of-care (SoC) chemotherapy in previously-untreated
patients with metastatic (Stage IV) 1st-line non-small cell lung
cancer (NSCLC).
MYSTIC
is an event-driven clinical trial and continues per protocol. Based
on current predictions, the final analysis of overall survival (OS)
is now expected in the second half of 2018 (previously anticipated
in the first half).
About MYSTIC
The
MYSTIC trial is a randomised, open-label, multi-centre, global
Phase III trial of Imfinzi
monotherapy or Imfinzi in
combination with tremelimumab versus SoC in treatment of patients
with epidermal growth factor receptor (EGFR) and anaplastic
lymphoma kinase (ALK) wild-type locally-advanced or metastatic
(Stage IV) 1st-line NSCLC.
The
trial is being conducted in 167 centres across 17 countries,
including the US, Canada, Europe, Russia, Australia and parts of
Asia including Japan, Korea, Thailand, Taiwan and Vietnam. Primary
endpoints include progression-free survival (in combination), which
read out in July 2017, and OS in monotherapy and in
combination.
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 has 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 investigated as a
monotherapy and/or 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 an investigational human monoclonal antibody 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 investigated 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 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 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, US., one of AstraZeneca's three global R&D
centres, with additional sites in Cambridge, UK, and Mountain View,
US. 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 is also 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:
12 March
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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