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
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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This
announcement contains inside information
27 July 2017 07:15 BST
TAGRISSO SIGNIFICANTLY IMPROVES PROGRESSION-FREE SURVIVAL IN THE
PHASE III FLAURA TRIAL FOR LUNG CANCER
Tagrisso met the primary endpoint,
demonstrating a statistically-significant and clinically-meaningful
progression-free survival benefit in 1st-line EGFRm non-small cell
lung cancer compared to current standard-of-care
treatment
AstraZeneca
today announced that the Phase III FLAURA trial showed a
statistically-significant and clinically-meaningful
progression-free survival (PFS) benefit with Tagrisso (osimertinib) compared to
current 1st-line standard-of-care treatment (erlotinib or
gefitinib) in previously-untreated patients with locally-advanced
or metastatic epidermal growth factor receptor mutation-positive
(EGFRm) non-small cell lung cancer (NSCLC).
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "The strong results
from the FLAURA trial are very exciting news for patients with EGFR
mutation-positive non-small cell lung cancer, providing physicians
with a potential new first-line treatment option to improve
outcomes in this disease. We will now initiate discussions with
global health authorities on the data and regulatory
submissions."
The
efficacy, safety and tolerability profiles for Tagrisso, erlotinib and gefitinib were
consistent with current knowledge. A full evaluation of the FLAURA
data is ongoing. Further results will be presented at a forthcoming
medical meeting.
About NSCLC
Lung
cancer is the leading cause of cancer death among both men and
women, accounting for about one-quarter of all cancer deaths, more
than breast, prostate and colorectal cancers combined.
Approximately 10-15% of patients in the US and Europe, and 30-40%
of patients in Asia have EGFRm NSCLC. These patients are
particularly sensitive to treatment with currently-available
EGFR-TKIs, which block the cell signalling pathways that drive the
growth of tumour cells. However, tumours almost always develop
resistance to EGFR-TKI treatment leading to disease progression.
Approximately half of patients develop resistance to approved
EGFR-TKIs such as gefitinib and erlotinib due to the resistance
mutation, EGFR T790M. Tagrisso targets this secondary mutation that
leads to disease progression. There is also a need for agents with
improved CNS efficacy since approximately 25% of patients with
EGFRm NSCLC have brain metastases at diagnosis, increasing to
approximately 40% within two years of diagnosis.
About Tagrisso
Tagrisso is a third generation, irreversible EGFR tyrosine
kinase inhibitor (TKI) designed to inhibit both EGFR sensitising
and EGFR T790M resistance mutations, with clinical activity against
central nervous system (CNS) metastases. Tagrisso (osimertinib) 40mg and 80mg
once-daily oral tablets have been approved in more than 50
countries, including the US, EU, Japan and China, for patients with
EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being investigated in
the adjuvant and metastatic first-line settings, including in
patients with and without CNS metastases, in leptomeningeal
metastases, and in combination with other treatments.
About FLAURA
FLAURA
assessed the efficacy and safety of Tagrisso 80mg once-daily
treatment versus standard-of-care EGFR-TKIs (either erlotinib
[150mg orally, once daily] or gefitinib [250mg orally, once daily])
in previously untreated patients with locally advanced or
metastatic EGFR mutation-positive NSCLC. The trial was a
double-blinded, randomised study, with 556 patients across 30
countries.
The
primary endpoint of the trial was PFS, and secondary endpoints
included overall survival, objective response rate, duration of
response, disease control rate, safety and measures of
health-related quality of life (HRQoL).
About AstraZeneca in Lung Cancer
AstraZeneca
is using ground-breaking science to develop a wide range of
medicines for patients with lung cancer. We are pioneering
precision medicines that target molecular mutations in tumour
cells, as well as those that aim to boost the power of the immune
response against cancer. We are committed to transforming outcomes
for patients with lung cancer, whose treatment options are
currently limited.
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 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
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.
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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