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 November
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.
AstraZeneca
provides update on Phase III MYSTIC
This announcement contains inside information
16 November 2018 07:00 GMT
AstraZeneca provides update on the Phase III MYSTIC trial
of
Imfinzi and tremelimumab in Stage IV non-small cell
lung cancer
AstraZeneca and MedImmune, its global biologics research and
development arm, today announced final overall survival (OS)
results for the Phase III MYSTIC trial, a randomised, open-label,
multi-centre, global trial of Imfinzi (durvalumab) monotherapy and the combination
of Imfinziand tremelimumab, an anti-CTLA4 antibody, versus
standard-of-care (SoC) platinum-based chemotherapy in
previously-untreated patients with Stage IV (metastatic) non-small
cell lung cancer (NSCLC).
In the primary analysis population of patients, whose tumours
express PD-L1 on 25% or more of their cancer cells as determined by
the VENTANA PD-L1 (SP263) Assay, Imfinzi monotherapy and the combination
of Imfinzi plus tremelimumab did not meet the primary
endpoints of improving OS compared to SoC chemotherapy. While the
OS result did not meet statistical significance, a hazard ratio
(HR) of 0.76 (97.54% CI 0.564-1.019; nominal p=0.036) was observed
with Imfinzimonotherapy. The combination therapy had an HR of
0.85 (98.77% CI 0.611-1.173; nominal p=0.202); the data support
further analysis in exploratory subgroups.
The safety and tolerability profiles for Imfinzi and the Imfinzi plus tremelimumab combination were
consistent with previous trials.
Sean Bohen, Executive Vice President, Global Medicines Development
and Chief Medical Officer, said: "We are encouraged to see
that Imfinzi monotherapy activity is in-line with that of
the anti-PD-1 class in previously-untreated patients with Stage IV
non-small cell lung cancer; however, we are disappointed that these
results missed statistical significance. We remain confident
in Imfinzias the cornerstone of our IO programme and
continue to evaluate its potential in ongoing non-small cell lung
cancer trials, including Imfinzi and Imfinzi plus tremelimumab in combination with
chemotherapy."
Imfinzi is approved for
unresectable, Stage III NSCLC in more than 40 countries, including
the US, EU and Japan, based on the Phase III PACIFIC
trial. Imfinzi is currently being tested in a range of
Phase III trials for Stage IV NSCLC.
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Immuno-oncology Phase III trials in Stage IV, 1st-line
NSCLC
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PEARL
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Imfinzi monotherapy vs SoC chemotherapy
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NEPTUNE
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Imfinzi + tremelimumab vs SoC chemotherapy
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POSEIDON
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Imfinzi + chemotherapy or Imfinzi + tremelimumab +
chemotherapy
vs SoC
chemotherapy
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About MYSTIC
The MYSTIC trial is a randomised, open-label, multi-centre, global
Phase III trial of Imfinzi(durvalumab) monotherapy
or Imfinzi in combination with tremelimumab versus SoC
chemotherapy in the 1st-line treatment of patients with epidermal
growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK)
wild-type, locally-advanced or metastatic (Stage IV) non-small cell
lung cancer.
The trial was 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 included progression-free survival (PFS) for the
combination, and OS in monotherapy and in combination therapy. The
combination of Imfinzi and tremelimumab did not meet the primary
endpoint of improving PFS compared to SoC in patients whose tumours
express PD-L1 on 25% or more of their cancer cells in July
2017.
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 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, urothelial carcinoma, head and
neck squamous cell carcinoma, hepatocellular carcinoma and blood
cancers.
About Stage IV NSCLC
Lung cancer is the leading cause of cancer death among both men and
women and accounts for about one-fifth of all cancer deaths: more
than breast, prostate and colorectal cancers combined. Lung cancer
is broadly split into NSCLC and SCLC, with 80-85% classified as
NSCLC. Stage IV is the most advanced form of lung cancer and is
often referred to as metastatic disease. Approximately 85% of Stage
IV patients are diagnosed after the tumour has spread outside of
the lung. For these patients, prognosis is particularly poor, as
only 1 in 10 will be alive five years after diagnosis.
About AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and potential
new medicines in late-stage clinical development for the treatment
of different forms of lung cancer spanning several stages of
disease and lines of therapy. We aim to address the 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, ADAURA and LAURA Phase
III trials.
Our extensive late-stage Immuno-Oncology programme focuses on
75-80% of patients with lung cancer without a known genetic
mutation. Imfinzi, an anti-PDL1 antibody is in development as
monotherapy (ADJUVANT BR.31, PACIFIC-2, PACIFIC-5, MYSTIC and PEARL
Phase III trials) and in combination with tremelimumab and/or
chemotherapy (MYSTIC, NEPTUNE, POSEIDON, ADRIATIC and CASPIAN Phase
III trials).
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.
CONTACTS
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Media
Relations
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Karen
Birmingham
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UK/Global
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+44 203
749 5634
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Rob
Skelding
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UK/Global
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+44 203
749 5821
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Matt
Kent
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UK/Global
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+44 203
749 5906
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Gonzalo
Viña
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UK/Global
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+44 203
749 5916
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Jennifer
Hursit
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UK/Global
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+44 2033749
5762
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Jacob
Lund
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Sweden
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+46
8 553 260 20
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Michele
Meixell
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US
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+1 302
885 2677
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Investor
Relations
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Thomas
Kudsk Larsen
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+44 203
749 5712
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Henry
Wheeler
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Oncology
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+44 203
749 5797
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Christer
Gruvris
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Cardiovascular;
Metabolism
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+44 203
749 5711
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Nick
Stone
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Respiratory;
Renal
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+44 203
749 5716
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Josie
Afolabi
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Other
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+44 203
749 5631
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Craig
Marks
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Finance;
Fixed Income
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+44
7881 615 764
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Jennifer
Kretzmann
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Retail
Investors
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+44 203
749 5824
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US
toll-free
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+1 866
381 7277
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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:
16 November
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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