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
1.
AZ: positive CHMP
for Tagrisso first-line nsclc
27 April 2018 12:30 BST
TAGRISSO
RECEIVES POSITIVE EU CHMP OPINION FOR
1ST-LINE TREATMENT OF EGFR-MUTATED NON-SMALL CELL LUNG
CANCER
Recommendation based on FLAURA trial data showing unprecedented
median progression-free survival of 18.9 months for Tagrisso versus
10.2 months compared with current standard of care
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency has adopted a positive opinion,
recommending a change to the terms of the Marketing Authorisation
for Tagrisso (osimertinib) to include 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 recommendation 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.
Sean Bohen, Executive Vice President, Global Medicines Development
and Chief Medical Officer at AstraZeneca, said: "This positive
recommendation acknowledges Tagrisso's potential as a new 1st-line standard of care for
patients with EGFR-mutated NSCLC in Europe. It reflects the
strength of the FLAURA data that show Tagrisso delivered a statistically-significant and
clinically-meaningful improvement in progression-free survival over
the EGFR-TKI comparator arm across all pre-specified patient
subgroups, including those with or without central nervous system
metastases."
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)
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136 (49)
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206 (74)
|
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Median PFS (95% 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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HR (95% CI); P-value
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0.46 (0.37, 0.57); P < 0.0001
|
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Overall Survival (OS)
|
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Number of deaths, (25% maturity)
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58 (21)
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83 (30)
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Median OS in months (95% CI)
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NC
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NC
|
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HR (95% CI); P-value
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0.63 (0.45, 0.88); P=0.0068 (NS)*
|
|
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
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Duration of Response (DoR)
|
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Median DoR (95% CI)
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17.2 months (13.8, 22.0)
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8.5 months (7.3, 9.8)
|
*Not statistically significant at current level of
maturity
Safety data for Tagrisso were in line with those observed in prior clinical
trials. Tagrisso was well tolerated, with fewer Grade 3 or higher
adverse events (AEs) than with standard EGFR-TKIs (34% vs. 45%). In
all patients, the most common adverse reactions were rash (58%
[1.1% Grade ≥3] for Tagrisso vs. 78% [6.9% Grade ≥3] for the comparator
arm), diarrhoea (58% [2.2% Grade ≥3] for Tagrisso vs. 57% [2.5% Grade ≥3] for the comparator
arm) and dry skin (36% [<1% Grade ≥3] for
Tagrisso
vs. 36% [1.1% Grade ≥3] for the
comparator arm).
The positive opinion from the CHMP will now be reviewed by the
European Commission, which has the authority to approve medicines
for the 28 EU member countries plus Iceland, Norway and
Liechtenstein. Earlier this month, Tagrisso was approved in the US for the 1st-line treatment
of patients with metastatic NSCLC whose tumours have EGFR mutations
(exon 19 deletions or exon 21 L858R mutations). In addition to the
EU, Tagrisso is under regulatory review in Japan for use in the
1st-line treatment setting with a decision anticipated in the
second half of 2018. Other global health authority reviews and
submissions are also 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 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 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
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:
27 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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