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 August
2019
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.
Tagrisso
significantly improves overall survival
9 August 2019 07:00 BST
Tagrisso significantly
improves overall survival in the Phase III FLAURA trial for
1st-line EGFR-mutated non-small cell lung
cancer
Tagrisso is the only medicine demonstrating
statistically-significant overall survival benefit in this setting.
Also increased the time patients with central nervous
system metastases lived without disease
progression
AstraZeneca today
announced positive overall survival (OS) results from the Phase III
FLAURA trial, a randomised, double-blinded, multi-centre trial
of Tagrisso (osimertinib)
in previously-untreated patients with locally-advanced
or metastatic non-small cell lung cancer (NSCLC) whose
tumours have epidermal growth factor receptor (EGFR)
mutations.
Tagrisso showed a
statistically-significant and clinically-meaningful improvement in
OS, a secondary endpoint in the FLAURA Phase III
trial, compared with erlotinib or gefitinib both of which were
previous standard-of-care (SoC) treatments in this
setting. The FLAURA trial met its primary
endpoint in July 2017,
showing a statistically-significant and clinically-meaningful
improvement in progression-free survival (PFS), increasing the
time patients lived without disease progression or death from any
cause. The safety and tolerability
of Tagrisso was consistent with its established
profile.
José Baselga,
Executive Vice President, Oncology R&D said: "Today's positive
results show that Tagrissoprovides
an unprecedented survival outcome versus previous
standard-of-care epidermal growth factor
receptor tyrosine kinase inhibitors,
reaffirming Tagrisso as
the 1st-line standard-of-care for EGFR-mutated metastatic non-small
cell lung cancer."
AstraZeneca plans to present the OS results from the FLAURA trial
at a forthcoming medical meeting.
Tagrisso is currently
approved in 74 countries, including the US, Japan and the EU, for
1st-line EGFRm metastatic NSCLC.
About lung cancer
Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-fifth of all cancer deaths, more
than breast, prostate and colorectal cancers
combined.1 Lung
cancer is broadly split into NSCLC and small cell lung cancer
(SCLC), with 80-85% classified as NSCLC.2Approximately
10-15% of NSCLC patients in the US and Europe, and 30-40% of
patients in Asia have EGFR-mutated (EGFRm)
NSCLC.3-5 These
patients are particularly sensitive to treatment with EGFR-tyrosine
kinase inhibitors (TKI) which block the cell-signalling pathways
that drive the growth of tumour cells. Approximately 25% of
patients with EGFRm NSCLC have brain metastases at diagnosis,
increasing to approximately 40% within two years of
diagnosis.6 The
presence of brain metastases often reduces median survival to less
than eight months.7
About Tagrisso
Tagrisso (osimertinib) is
a third-generation, irreversible EGFR-TKI designed to inhibit both
EGFR-sensitising and EGFR T790M-resistance mutations, with clinical
activity against central nervous system
metastases. Tagrisso 40mg and 80mg once-daily oral tablets have
now received approval in more than 70 countries, including the US,
Japan and the EU, for 1st-line EGFRm advanced NSCLC, and in more
than 80 countries, including the US, Japan, China and the EU, for
2nd-line use in patients with EGFR T790M mutation-positive advanced
NSCLC. Tagrisso is also being developed in the adjuvant
setting (ADAURA trial), in the locally-advanced unresectable
setting (LAURA), in combination with chemotherapy (FLAURA2) and
with potential new medicines (SAVANNAH,
ORCHARD).
About FLAURA
The FLAURA trial assessed
the efficacy and safety of Tagrisso 80mg
orally once daily vs. comparator EGFR-TKIs (either erlotinib [150mg
orally, once daily] or gefitinib [250mg orally, once daily]) in
previously-untreated patients with locally-advanced or metastatic
EGFRm NSCLC. The trial was double-blinded and randomised, with 556
patients across 29 countries.
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, lines of therapy and modes of action. 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 (gefitinib) and Tagrisso, and ongoing Phase III trials ADAURA, LAURA,
FLAURA and FLAURA2 as well as the Phase II combination trials
SAVANNAH and ORCHARD.3-5
Our extensive late-stage Immuno-Oncology programme focuses on lung
cancer patients without a known genetic mutation which represents
up to 50% of all patients with lung
cancer. Imfinzi (durvalumab),
an anti-PDL1 antibody, is in development as monotherapy (Phase III
trials ADJUVANT BR.31, PACIFIC-4, PACIFIC-5, and PEARL) and in
combination with tremelimumab and/or chemotherapy (Phase III trials
AEGEAN, PACIFIC-2, NEPTUNE, POSEIDON, ADRIATIC and
CASPIAN).
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 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, CVRM and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit astrazeneca.com and
follow us on Twitter @AstraZeneca.
Media Relations
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Gonzalo
Viña
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+44 203 749 5916
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Rob
Skelding
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Oncology
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+44 203 749 5821
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Rebecca
Einhorn
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Oncology
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+1 301 518 4122
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Matt
Kent
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BioPharmaceuticals
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+44 203 749 5906
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Jennifer
Hursit
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Other
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+44 203 749 5762
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Christina
Malmberg Hägerstrand
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Sweden
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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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BioPharmaceuticals (cardiovascular, metabolism)
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+44 203 749 5711
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Nick
Stone
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BioPharmaceuticals (respiratory, renal)
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+44 203 749 5716
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Josie
Afolabi
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Other medicines
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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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Kretzmann
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US
toll-free
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. World Health Organization. International Agency for Research on
Cancer. Globocan Worldwide Fact Sheet 2018. Available at
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessed
May 2019.
2. LUNGevity Foundation. Types of Lung Cancer. Available
at https://www.lungevity.org/about-lung-cancer/lung-cancer-101/types-of-lung-cancer.
Accessed May 2019.
3. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on
Cytological and Histological Samples in Non-Small Cell Lung Cancer:
a Polish, Single Institution Study and Systematic Review of
European Incidence. Int J Clin Exp Pathol. 2013:6;2800-12. Accessed
May 2019.
4. Keedy VL, et al. American Society of Clinical Oncology
Provisional Clinical Opinion: Epidermal Growth Factor Receptor
(EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell
Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor
Therapy. J Clin Oncol. 2011:29;2121-27. Accessed May
2019.
5. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review
of Available Methods and Their Use for Analysis of Tumour Tissue
and Cytology Samples. J Clin Pathol. 2013:66;79-89. Accessed May
2019.
6. Rangachari, et al. Brain Metastases in Patients with
EGFR-Mutated or ALK-Rearranged Non-Small-Cell Lung Cancers. Lung
Cancer. 2015;88,108-111. Accessed May 2019.
7. Ali A, et al. Survival of Patients with Non-small-cell Lung
Cancer After a Diagnosis of Brain Metastases. Curr Oncol.
2013;20(4):e300-e306. Accessed May 2019.
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:
09 August
2019
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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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