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 August
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.
AZ's
Tagrisso approved in Japan for 1st-line NSCLC
21 August 2018
Tagrisso
approved in Japan for 1st-line
treatment
of EGFR-mutated non-small cell lung cancer
1st-line Tagrisso offers a potential new standard of
care
for Japanese lung cancer patients
AstraZeneca
today announced that the Japanese Ministry of Health, Labour and
Welfare (MHLW) has approved Tagrisso (osimertinib) for the 1st-line
treatment of patients with inoperable or recurrent epidermal growth
factor receptor (EGFR) mutation-positive non-small cell lung cancer
(NSCLC), following priority review. The approval is based on
results from the global Phase III FLAURA trial which included
Japanese patients and which were published in the New
England Journal of Medicine.
Dave
Fredrickson, Executive Vice President, Head of the Oncology
Business Unit, said: "Tagrisso is already approved in Japan for the treatment of
patients with EGFR T790M mutation-positive inoperable or recurrent
NSCLC that is resistant to existing 1st-line EGFR-inhibitor
medicines. Today's approval moves the use of Tagrisso to the 1st-line setting, replacing older medicines
which, given the high prevalence of the EGFR mutation in
Japan, offers an important new treatment option for these
patients."
The
FLAURA trial compared Tagrisso to current 1st-line EGFR
tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib in
previously-untreated patients with locally-advanced or metastatic
EGFR-mutated (EGFRm) NSCLC. In the
trial, Tagrisso demonstrated
superior progression-free survival (PFS) of 18.9 months compared
with 10.2 months for the comparator arm (see table below),
and this benefit was consistent across
all subgroups including in patients with or without central nervous
system (CNS) metastases, an important benefit for lung
cancer patients.
FLAURA trial efficacy results according to investigator
assessment
|
Efficacy parameter
|
Tagrisso(N=279)
|
EGFR-TKI comparator (gefitinib or erlotinib)
(N=277)
|
|
PFS
|
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Number of events (62% maturity)
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136 (49)
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206 (74)
|
|
Median PFS (95%
confidence interval [CI])
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18.9 months (15.2, 21.4)
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10.2 months (9.6, 11.1)
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Hazard ratio (HR [95% CI]); p-value
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0.46 (0.37, 0.57); p < 0.0001
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Objective response rate (ORR)
|
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Response rate (95% CI)
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80% (75, 85)
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76% (70, 81)
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Odds ratio (95% CI); p-value
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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)
|
Safety data for Tagrisso in the FLAURA trial were in line with those
observed in prior clinical trials. Tagrisso was generally well tolerated, with Grade 3 or
higher adverse events (AEs) occurring in 34% of patients
taking Tagrisso and 45% in the comparator arm. The most
common adverse reactions in patients treated with Tagrisso were rash/acne (54.5%),
diarrhoea (49.5%), dry skin/eczema (33.3%) and nail disorder
including paronychia (32.6%) (at the time of
supplementary approval).
Tagrisso has now received
approval in 40 countries for the 1st-line treatment of patients
with metastatic EGFRm NSCLC, including the US, Japan and in Europe.
Other global health authority reviews and submissions are
ongoing.
About EGFRm 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. Lung cancer
is broadly split into NSCLC and small cell lung cancer (SCLC), with
80-85% classified as NSCLC. Approximately 10-15% of NSCLC patients
in the US and Europe, and 30-40% of patients in Asia have 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. Approximately 25% of patients with EGFRm
NSCLC have brain metastases at diagnosis, increasing to
approximately 40% within two years of diagnosis. The presence of
brain metastases often reduces median survival to less than 8
months.
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 now received approval in
39 countries, including the US, Japan and in Europe, for 1st-line
EGFRm advanced NSCLC, and more than 75 countries, including the US,
Japan, China and in Europe, for 2nd-line use in patients with EGFR
T790M mutation-positive advanced NSCLC. Tagrisso is also being developed
in the adjuvant setting (ADAURA), in the locally-advanced
unresectable setting (LAURA), and in combination with other
treatments.
About the FLAURA trial
The FLAURA trial assessed the efficacy and safety
of Tagrisso 80mg orally 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 has a comprehensive portfolio of approved and potential
new medicines in late-stage clinical development for the treatment
of lung cancer across all stages of disease and lines of therapy.
We aim to address the unmet needs of patients with EGFRm NSCLC with
our approved medicines, Iressa and Tagrisso, and with the Phase III ADAURA and LAURA
trials.
Our Immuno-Oncology portfolio includes Imfinzi, an anti-PDL1 antibody, which is in development
as monotherapy (ADJUVANT, PACIFIC2, MYSTIC and PEARL trials) and in
combination with tremelimumab and/or chemotherapy (MYSTIC, NEPTUNE,
CASPIAN, and POSEIDON trials).
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 precision 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. 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:
21 August
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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