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 April
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
19 April 2018 07:00 BST
US FDA APPROVES TAGRISSO AS
1ST-LINE TREATMENT FOR EGFR-MUTATED NON-SMALL CELL LUNG
CANCER
1st-line use of Tagrisso offers potential new standard of
care
Tagrisso delivered unprecedented median progression-free survival
of 18.9 months versus 10.2 months compared with current standard of
care
AstraZeneca
today announced that the US Food and Drug Administration (FDA) has
approved Tagrisso
(osimertinib) for the 1st-line treatment of patients with
metastatic non-small cell lung cancer (NSCLC) whose tumours have
epidermal growth factor receptor (EGFR) mutations, (exon 19
deletions or exon 21 L858R mutations), as detected by an
FDA-approved test. The approval is based on results from the Phase
III FLAURA trial, which were presented at the European Society of
Medical Oncology 2017 Congress and published in
the New
England Journal of Medicine.
Dave Fredrickson, Executive Vice President, Head of the Oncology
Business Unit at AstraZeneca, said: "Today's FDA approval of
Tagrisso
in the 1st-line setting is an exciting
milestone for patients and our company. Tagrisso delivered unprecedented median
progression-free survival data across all pre-specified patient
subgroups, including patients with or without CNS metastases, and
could prolong the lives of more patients without their tumours
growing or spreading."
Dr.
Suresh S. Ramalingam, Principal Investigator of the FLAURA trial,
from Winship Cancer Institute of Emory University, Atlanta, said:
"The approval of osimertinib in the 1st-line setting represents a
major advance in the treatment of patients with EGFR mutations and
a significant change in the treatment paradigm. Osimertinib
provides robust improvements in progression-free survival with no
unexpected safety signals compared to the previous generation of
EGFR inhibitors."
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. Tagrisso met the primary endpoint of
progression-free survival (PFS) (see table below). PFS results with
Tagrisso were consistent
across all pre-specified patient subgroups, including in patients
with or without central nervous system (CNS) metastases. Overall
survival data were not mature at the time of the final PFS
analysis.
FLAURA Efficacy Results According to Investigator
Assessment
|
|
Tagrisso
(N=279)
|
EGFR-TKI
(gefitinib or erlotinib)
(N=277)
|
|
Progression-Free Survival (PFS)
|
|
Median
PFS
(95%
confidence interval [CI])
|
18.9
months
(15.2,
21.4)
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10.2
months
(9.6,
11.1)
|
|
Hazard
Ratio (95% CI)
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0.46
(0.37, 0.57)
|
|
P-value
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P < 0.0001
|
|
Objective Response Rate (ORR)*
|
|
ORR
(95%
CI)
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77%
(71,
82)
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69%
(63,
74)
|
|
Complete
response
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2%
|
1%
|
|
Partial
response
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75%
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68%
|
|
Duration of Response (DoR)*
|
|
Median
DoR
(95%
CI)
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17.6
months
(13.8,
22.0)
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9.6
months
(8.3,
11.1)
|
|
*Confirmed
responses
|
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 (≥20%) in patients treated with Tagrisso were diarrhoea (58%), rash (58%), dry skin (36%), nail toxicity (35%),
stomatitis (29%), fatigue (21%) and decreased appetite
(20%).
In the
US, Tagrisso is already
approved for the 2nd-line treatment of patients with metastatic
EGFRm NSCLC, whose disease has progressed on or after a 1st-line
EGFR-TKI therapy and who have developed the secondary T790M
mutation, as detected by an FDA-approved test. In 2017,
Tagrisso was granted
Breakthrough
Therapy and Priority
Review designations
by the US FDA in the 1st-line treatment setting. Tagrisso is under regulatory review in
the European Union and Japan for use in the 1st-line treatment
setting with regulatory decisions anticipated in the second half of
2018.
Tagrisso received its first approval for 1st-line use based on
the FLAURA data in Brazil in patients with metastatic EGFRm NSCLC
on April 16, 2018
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 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 the US
and Brazil 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
investigated 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 platform 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
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.
Date:
19 April
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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