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 June
2018
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
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Act of 1934.
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assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
EU APPROVES
TAGRISSO FOR 1ST-LINE NSCLC
08 June 2018 17:30BST
The EU approves Tagrisso
for 1st-line treatment of EGFR-mutated non-small cell lung
cancer
1st-line Tagrisso offers a potential new standard of
care
Today the European Commission has granted marketing authorisation
for Tagrisso (osimertinib) as monotherapy for the 1st-line
treatment of adult patients with locally-advanced or metastatic
non-small cell lung cancer (NSCLC) with activating epidermal growth
factor receptor (EGFR) mutations. The approval is based on results
from the Phase III FLAURA trial published in
the New
England Journal of Medicine.
Dave Fredrickson, Executive Vice President, Head of the Oncology
Business Unit at AstraZeneca, said: "Today's approval is an
exciting advance in bringing a potential new standard of care to
patients with EGFR-mutated NSCLC in the EU. This milestone is also
a step forward for our Company, marking another regional approval
for Tagrisso in the 1st-line setting."
Dr. David Planchard, Associate Professor of Medicine, Head of
Thoracic Group, Gustave Roussy cancer center, France said: "The
FLAURA trial is changing medical practice in the 1st-line treatment
of EGFR-mutated NSCLC. The progression-free survival benefit seen
in the trial is unprecedented for patients with an EGFR mutation,
and this benefit was consistent across all subgroups including in
patients with or without central nervous system metastases.
Further, the preliminary overall survival data, while not
statistically significant at the time of the interim analysis, is
promising, with a 37 percent reduction in the risk of
death."
The
approval follows the positive
opinion from the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency.
FLAURA efficacy results according to investigator
assessment
|
Efficacy parameter
|
Tagrisso(N=279)
|
EGFR-TKI comparator (gefitinib or erlotinib)
(N=277)
|
|
Progression-free survival (PFS)
|
|
Number
of events (62% maturity)
|
136
(49)
|
206
(74)
|
|
Median
PFS (95% CI)
|
18.9
months (15.2, 21.4)
|
10.2
months (9.6, 11.1)
|
|
HR (95%
CI); p-value
|
0.46
(0.37, 0.57); p < 0.0001
|
|
Overall survival (OS)
|
|
Number
of deaths, (25% maturity)
|
58
(21)
|
83
(30)
|
|
Median
OS in months (95% CI)
|
NC
|
NC
|
|
HR (95%
CI); p-value
|
0.63 (0.45, 0.88); p=0.0068 (NS)*
|
|
Objective response rate (ORR)
|
|
Response
rate (95% CI)
|
80%
(75, 85)
|
76%
(70, 81)
|
|
Odds
ratio (95% CI); p-value
|
1.3
(0.9, 1.9); p=0.2421
|
|
Duration of response (DoR)
|
|
Median
DoR (95% CI)
|
17.2
months (13.8, 22.0)
|
8.5
months (7.3, 9.8)
|
*Not
statistically significant at current level of
maturity.
Safety data for Tagrisso from the FLAURA, AURA3, AURA and AURA2 trials were
evaluated. Tagrisso was well tolerated, with most adverse reactions
Grade 1 or 2 in severity. In all patients, the most common adverse
reactions were decreased leucocytes (68% [1.5% Grade ≥3]),
decreased lymphocytes (67% [7.2% Grade ≥3]), decreased
platelet count (54% [1.6% Grade ≥3]), diarrhoea (49% [1.2%
Grade ≥3]), rash (47% [0.9% Grade ≥3]), decreased
neutrophils (35% [4.1% Grade ≥3]), dry skin (33% [0.1% Grade
≥3]), paronychia (31% [0.3% Grade ≥3]), stomatitis (20%
[0.2% Grade ≥3]), and pruritus (17% [0.1% Grade
≥3]).
In the EU, Tagrisso is already indicated for the treatment of patients
with locally-advanced or metastatic EGFR T790M mutation-positive
NSCLC. Today's approval follows the recent approvals of
Tagrisso
for the 1st-line treatment of patients
with metastatic EGFR-mutated (EGFRm) NSCLC in the US, Brazil and
the Russian Federation. Tagrisso is also under regulatory review in Japan for use
in the 1st-line treatment setting with a decision anticipated in
the second half of 2018, with other global health authority reviews
and submissions ongoing.
About NSCLC
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.
Approximately 10-15% of patients in the US and Europe, and 30-40%
of patients in Asia have EGFR-mutated (EGFRm) NSCLC. These patients
are particularly sensitive to treatment with EGFR-TKIs, which block
the cell-signalling pathways that drive the growth of tumour cells.
Tumours almost always develop resistance to EGFR-TKI treatment,
however, leading to disease progression. Approximately half of
patients develop resistance to approved EGFR-TKIs such as
gefitinib, erlotinib and afatinib due to the EGFR T790M resistance
mutation. There is also a need for medicines 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 (osimertinib) is
a third-generation, irreversible EGFR-TKI designed to inhibit both
EGFR-sensitising and EGFR T790M-resistance mutations, with clinical
activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral
tablets have been approved in four countries, including the US and
EU, for 1st-line EGFRm advanced NSCLC, and in more than 75
countries including the US, EU, Japan and China for patients with
EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being tested in the adjuvant setting
and in combination with other treatments.
About the FLAURA trial
The FLAURA trial assessed the efficacy and safety
of Tagrisso 80mg once daily vs. 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 EGFRm NSCLC. The trial was
double-blinded and randomised, with 556 patients across 29
countries.
About AstraZeneca in Lung Cancer
AstraZeneca is committed to developing medicines to help every
patient with lung cancer. We have three approved medicines and a
growing pipeline that targets genetic changes in tumour cells and
boosts the power of the immune response against cancer. Our
unrelenting pursuit of science aims to deliver more breakthrough
therapies with the goal of extending and improving the lives of
patients across all stages of disease and lines of
therapy.
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, Cardiovascular, Renal &
Metabolism 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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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:
08 June 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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