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 July 2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
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This announcement contains inside information
27 July 2017 07:10 BST
ASTRAZENECA REPORTS INITIAL RESULTS
FROM THE ONGOING MYSTIC TRIAL IN STAGE IV LUNG CANCER
Imfinzi plus tremelimumab combination did not meet a primary
endpoint of progression-free survival compared to
chemotherapy
The MYSTIC trial continues as planned to assess the additional
primary endpoints of overall survival for Imfinzi monotherapy and
for the Imfinzi plus tremelimumab combination
AstraZeneca
and MedImmune, its global biologics research and development arm,
today announced progression-free survival (PFS) results for the
Phase III MYSTIC trial, a randomised,
open-label, multi-centre, global trial of Imfinzi (durvalumab) monotherapy or Imfinzi 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).
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 (as determined by the VENTANA PD-L1
(SP263) assay).
As a
secondary endpoint, although not formally tested, Imfinzi monotherapy would not have met
a pre-specified threshold of PFS benefit over SoC in this disease
setting.
The
trial will continue to assess two additional primary endpoints of
overall survival (OS) for Imfinzi monotherapy and OS for the
Imfinzi plus tremelimumab
combination. Final OS data from both primary endpoints are expected
during the first half of 2018.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: “While the
results from the MYSTIC trial for progression free survival in
first-line Stage IV non-small cell lung cancer compared with
standard of care are disappointing, the trial was designed to
assess overall survival and we look forward to evaluating the
remaining primary endpoints of overall survival for both mono- and
combination therapy.”
AstraZeneca recently received accelerated approval from the US FDA
for Imfinzi in previously-treated patients with locally
advanced or metastatic urothelial carcinoma
(mUC).
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.
Lung cancer is an unapproved use of Imfinzi.
The
trial is being conducted in 167 centres across 17 countries,
including the US, Canada, Europe, parts of Asia including Japan,
Korea, Thailand, Taiwan and Vietnam, and in Russia and Australia.
Primary endpoints include PFS and OS.
About Imfinzi
Imfinzi (durvalumab), 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 be studied in multiple monotherapy
trials and combination trials with tremelimumab and other potential
new medicines in immuno-oncology. Imfinzi is being
assessed in Phase III trials as a monotherapy in various stages of
NSCLC, in small-cell lung cancer (SCLC), in mUC and in head and
neck squamous cell carcinoma (HNSCC). The combination of
Imfinzi and
tremelimumab is being assessed in Phase III trials in mUC, NSCLC,
SCLC and HNSCC and in Phase I/II trials in hepatocellular carcinoma
(HCC) and haematological malignancies.
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, mUC,
HNSCC, HCC 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 (durvalumab), an anti-PDL1
antibody, which is in development as monotherapy (ADJUVANT,
PACIFIC, MYSTIC, PEARL and ARCTIC trials) and in combination with
tremelimumab, an anti-CTLA-4 (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 vast majority of patients.
We are
pursuing a comprehensive clinical trial programme that includes
Imfinzi
(anti-PDL1) 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 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, 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, 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
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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
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Date:
27 July 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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