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 December 2016
Commission
File Number: 001-11960
AstraZeneca PLC
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12g3-2(b): 82-_____________
06 December 2016 09:30
TAGRISSO DEMONSTRATES
SUPERIORITY OVER CHEMOTHERAPY IN EGFR T790M MUTATION-POSITIVE
NON-SMALL CELL LUNG CANCER
First randomised Phase III trial (AURA3) of Tagrisso against
chemotherapy
Tagrisso reduced risk of disease progression by 70% and improved
progression-free survival (PFS) by almost six months
Patients with central nervous system metastases achieved similar
benefit as the overall patient population in pre-specified
exploratory subgroup analysis
AstraZeneca
today presented data from the AURA3 trial that is supportive of
Tagrisso (osimertinib)
potentially becoming the new standard of care for 2nd-line
treatment of patients with epidermal growth factor receptor (EGFR)
T790M mutation-positive locally-advanced or metastatic non-small
cell lung cancer (NSCLC). The first randomised Phase III data
showed that Tagrisso
2nd-line therapy improved progression-free survival (PFS) by 5.7
months compared with standard platinum-based doublet chemotherapy
(Hazard Ratio [HR]=0.3). The results were presented at the 17th
World Conference on Lung Cancer (WCLC) in Vienna, Austria, hosted
by the International Association for the Study of Lung Cancer, and
published simultaneously online in The New England Journal of
Medicine.
http://www.rns-pdf.londonstockexchange.com/rns/0793R_-2016-12-6.pdf
Sean Bohen, Executive Vice President, Global
Medicines Development and Chief Medical Officer at AstraZeneca,
said: "The confirmatory Phase III data suggest the potential
for Tagrisso to replace chemotherapy as the standard of care
for patients who have progressed following EGFR tyrosine kinase
inhibitor treatment. As lung cancer is the most common type of
cancer to spread to the brain, it is also encouraging to see the
activity of Tagrisso in patients with central nervous system
metastases whose prognosis is often particularly
poor."
AURA3
data showed Tagrisso offered a
statistically-significant improvement in PFS versus standard
platinum-based doublet chemotherapy (10.1 months vs 4.4 months,
hazard ratio [HR] 0.30; 95% confidence interval (CI):0.23, 0.41;
p<0.001). In the 34% of patients with central nervous system
(CNS) metastases at baseline, PFS was also significantly greater
with Tagrisso than with
platinum-based doublet chemotherapy (8.5 months vs 4.2 months, HR
0.32; 95% CI: 0.21, 0.49).
Dr.
Vassiliki A Papadimitrakopoulou, from the University of Texas MD
Anderson Cancer Center, Houston, Texas, USA, said: "The results of
AURA3 are not only statistically significant, but clinically
meaningful because it is the first time a targeted medicine like
Tagrisso
has shown improvement in
progression-free survival over standard platinum-pemetrexed
chemotherapy. It's very rewarding to be able to give this type of
news to patients, as it highlights the major advances we are making
in targeted lung cancer treatments."
Professor Tony Mok,
from the Chinese University of Hong Kong, Hong Kong said: "The
superiority of Tagrisso in progression free
survival and response rate over platinum-pemetrexed chemotherapy
suggests we may be moving towards a new standard of care for
patients with resistance to EGFR TKI. With the publication of the
AURA3 data, clinicians should perform T790M mutation testing
to ensure Tagrisso be given
to patients who are most likely to benefit."
The
AURA3 safety data for Tagrisso were in line with previous
experience. Grade ≥3 drug-related adverse events (AEs) were
reported in 6% of patients (n=16) treated with Tagrisso and 34% (n=46) treated with
platinum-based doublet chemotherapy. The most common drug-related
AEs in the Tagrisso group,
were diarrhoea (29% overall; 1% Grade ≥3) and rash (28%
overall; <1% Grade ≥3) and, in the chemotherapy group,
they were nausea (47% overall; 3% Grade ≥3) and
decreased appetite (32% overall; 3% Grade ≥3).
The
data for AURA3 are consistent with those previously presented in
the Phase II trials, AURA2 and AURA extension. This consistency
extends to testing of tissue and plasma samples for the detection
of the EGFR T790M resistance mutation. In AURA3, approximately half
of patients with T790M in tumour tissue also had the T790M mutation
detected in plasma. Clinical benefits were reported with
Tagrisso compared to
platinum-based doublet chemotherapy, irrespective of whether the
T790M mutation was identified by plasma ctDNA or tissue testing.
When feasible, tissue testing is recommended for patients with a
negative plasma T790M test.
Tagrisso was granted accelerated approval by the US Food and
Drug Administration (FDA) in November 2015 for the treatment of
patients with metastatic epidermal growth factor receptor (EGFR)
T790M mutation-positive non-small cell lung cancer (NSCLC), as
detected by an FDA-approved test, who have progressed on or after
EGFR tyrosine kinase inhibitor (TKI) therapy. In the EU,
Tagrisso was granted
conditional marketing authorisation for adult patients with locally
advanced or metastatic EGFR T790M NSCLC, irrespective of previous
EGFR-TKI treatment by the European Medicines Agency (EMA) in
February 2016.
In
addition, Tagrisso received
approval in Japan in March 2016 for the treatment of patients with
EGFR T790M mutation-positive inoperable or recurrent NSCLC that is
resistant to EGFR TKI therapy, and it is currently under fast frack
review in China, where nearly half of lung cancer patients are
thought to have the EGFR mutation.
To view
and download additional supporting materials including
backgrounders, infographics and images, please visit:
https://www.astrazeneca.com/oncology-events.html, where they
are available throughout WCLC 2016.
About AURA3
AURA3
compared the efficacy and safety of Tagrisso 80mg once daily and
platinum-based doublet chemotherapy (platinum-pemetrexed) in 419
patients with EGFR T790M mutation-positive, locally-advanced or
metastatic NSCLC whose disease had progressed on or after treatment
with a previous EGFR tyrosine kinase inhibitor (TKI). The trial was
carried out in more than 130 locations worldwide, including the
USA, Canada, Europe, China, Japan, Korea, Taiwan and
Australia.
The
primary endpoint of the trial was PFS, and secondary endpoints
included overall survival (OS), overall response rate (ORR),
duration of response (DoR), disease control rate (DCR), safety and
measures of health-related quality of life (HRQoL).
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-third of all cancer deaths and more
than breast, prostate and colorectal cancers combined. Among
patients with lung cancer, 25% to 40% have brain metastases at some
time in the course of their disease. Patients who have the EGFRm
form of NSCLC, which occurs in 10-15% of NSCLC patients in the US
and Europe and 30-40% of NSCLC patients in Asia, are
particularly sensitive to treatment with currently-available
EGFR-TKIs, which block the cell signalling pathways that drive the
growth of tumour cells. However, tumours almost always develop
resistance to treatment, leading to disease progression.
Approximately two-thirds of patients develop resistance to approved
EGFR-TKIs such as gefitinib and erlotinib due to the secondary
mutation, T790M.
About Tagrisso
Tagrisso (osimertinib, AZD9291) 80mg once daily tablet
is approved in the US, EU, Japan, Canada, Switzerland, Israel,
Mexico, Australia and a number of other countries as the first
treatment for patients with locally-advanced or metastatic EGFR
T790M mutation-positive NSCLC. Tagrisso is also approved in South Korea in the same
indication. Eligibility for treatment with Tagrisso is
dependent on confirmation that the EGFR T790M mutation is present
in the tumour.
Tagrisso has one of the fastest development programmes,
from start of clinical trials to approval in just over two and a
half years. Tagrisso is as an irreversible
EGFR inhibitor, born out of scientific exploration and engineered
to combat the mechanism of resistance by targeting the T790M
resistance mutation. Tagrisso is also investigated in the
adjuvant and metastatic first-line settings, including in patients
with and without brain metastases, in leptomeningeal disease, and
in combination with other treatments.
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 New Oncology as one of AstraZeneca's six
Growth Platforms 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, the genetic drivers of cancer 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 main therapy areas - Oncology, Cardiovascular &
Metabolic Diseases 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.
AstraZeneca
PLC
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Date:
06 December 2016
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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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