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2017-09-09

AstraZeneca: AstraZeneca's Tagrisso shows potential as a new standard of care in 1st-line EGFR-mutated lung cancer at ESMO...

Phase III FLAURA trial results show Tagrisso reduced the risk of
progression or death by more than half, with consistent benefit
across all subgroups, including patients with and without brain
metastases

Unprecedented median progression-free survival (PFS) of 18.9 months
compared with 10.2 months for the current standard of care

Clinically-meaningful preliminary overall survival benefit

AstraZeneca has presented the full results of the Phase III FLAURA
trial, which support Tagrisso's (osimertinib) clear potential as a
new standard of care (SoC) in the 1st-line treatment of adult
patients with locally-advanced or metastatic epidermal growth factor
receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

Results of the Phase III FLAURA trial were included at the
Presidential Symposium I of the European Society of Medical Oncology
(ESMO) 2017 Congress in Madrid, Spain, and demonstrate a superior,
clinically-meaningful PFS advantage with Tagrisso compared with
current SoC EGFR-TKIs (erlotinib or gefitinib).

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "The FLAURA data are
truly exciting. Until now, even with the therapeutic advances offered
by the first- and second-generation EGFR inhibitors, less than 20% of
EGFR mutation-positive NSCLC patients survive for five years. The
FLAURA data suggest early and sustained benefit with Tagrisso that
has the potential to significantly impact long-term patient outcomes
and help address the considerable unmet need that remains."

Dr. Suresh S. Ramalingam, Principal Investigator of the FLAURA trial,
from the Winship Cancer Institute of Emory University, Atlanta, USA,
said: "The FLAURA data for osimertinib are likely to result in a
major paradigm shift in the treatment of patients with EGFR
mutation-positive advanced lung cancer. Not only did the trial
demonstrate a robust improvement in efficacy with osimertinib when
compared to other commonly-used EGFR inhibitors, the side effects
profile was also more favourable with osimertinib".

Summary of key efficacy results:

+--------------+--------+--------------------+----------------------------+
|Endpoint |Tagrisso|SoC |Hazard ratio (HR)/ |
| | | |Odds ratio (OR) |
+--------------+--------+--------------------+----------------------------+
|PFS |18.9 |10.2 months (median)|HR 0.46 |
|(primary |months | |95% CI, 0.37-0.57, p<0.0001 |
|endpoint) |(median)| | |
+--------------+--------+--------------------+----------------------------+
|OS at 25% |N/A |N/A | HR 0.63 |
|maturity | | |95% CI, 0.45-0.88, p=0.0068*|
+--------------+--------+--------------------+----------------------------+
|Duration of |17.2 |8.5 months(median) |N/A |
|Response (DoR)|months | | |
| |(median)| | |
+--------------+--------+--------------------+----------------------------+
|Objective |80% |76% |OR 1.28 |
|Response Rate | | |0.85-1.93, p=0.2335 |
|(ORR) | | | |
+--------------+--------+--------------------+----------------------------+

*0.0015 was the threshold required for statistical significance at the
current level of maturity. A final OS analysis is planned at a later
stage.

Additional highlights from the FLAURA data include:

· Superior progression-free survival (PFS): Patients on Tagrisso had
less than half the risk of progression or death compared with
patients on erlotinib or gefitinib (hazard ratio [HR] 0.46; 95%
confidence interval [CI] 0.37-0.57; p<0.0001). The median PFS was
18.9 months for patients on Tagrisso vs.10.2 months for patients in
the comparator arm.

· Clinically-meaningful preliminary overall survival (OS) data at
25% maturity: The hazard ratio for OS was 0.63 (95% CI: 0.45-0.88;
p=0.0068) favouring Tagrisso. Overall survival data were 25% mature
at the time of the interim analysis (21% of the patients on Tagrisso
had died and 30% of the patients on the comparator arm had died). The
p-value of 0.0068 was not below the threshold of 0.0015 required for
statistical significance at the current level of maturity. A final OS
analysis is planned at a later stage.

· PFS improvements consistent across subgroups: Improvements in PFS
with Tagrisso were consistent across all pre-specified patient
subgroups, with at least a 40% reduction in the risk of progression
or death, including in patients with/without central nervous system
(CNS) metastases at study entry, Asian/non-Asian patients, patients
with/without prior smoking history, and patients with exon 19
deletion/L858R.

· Impressive duration of response (DoR) and objective response rate
(ORR): Patients treated with Tagrisso had more than double the median
DoR than those on the comparator arm (17.2 months vs. 8.5 months),
and an ORR (a measurement of tumour shrinkage) of 80% vs. 76% with
the comparator arm (odds ratio 1.28 [0.85-1.93], p=0.2335).

The FLAURA safety data for Tagrisso were in line with those observed
in prior clinical trials, with a low rate of Grade ?3 adverse events
(AEs). In patients treated with Tagrisso, the most common AEs were
diarrhoea (58% [2% Grade ?3]) and dry skin (32% [<1% Grade ?3]), and
in the comparator arm group, the most common AEs were diarrhoea (57%
[3% Grade ?3]) and dermatitis acneiform (48% [5% Grade ?3]). Of the
patients on Tagrisso, 33.7% had a Grade ?3 AE, compared with 44.8% in
the comparator arm, and 13.3% of patients on Tagrisso had an AE
leading to treatment discontinuation compared with 18.1% in the
comparator arm.

AstraZeneca is in discussions with global health authorities regarding
regulatory submissions for Tagrisso based on the FLAURA data. A
status of regulatory submissions is usually provided with the
Company's quarterly results announcement.

Tagrisso is currently approved in more than 50 countries, including
the US, EU, Japan and China, as 2nd-line treatment for patients with
advanced NSCLC who progress following treatment with an EGFR-TKI due
to the EGFR T790M resistance mutation.

-ENDS-

Notes to Editors

About EGFR-mutated NSCLC

Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-quarter 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 currently-available EGFR-TKIs, which block the cell
signalling pathways that drive the growth of tumour cells. However,
tumours almost always develop resistance to EGFR-TKI treatment,
leading to disease progression. Approximately half of patients
develop resistance to approved EGFR-TKIs such as gefitinib and
erlotinib due to the resistance mutation, EGFR T790M. Tagrisso also
targets this secondary mutation that leads to disease progression.
There is also a need for agents 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 FLAURA

FLAURA 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 a double-blinded, randomised study, with
556 patients across 30 countries.

The primary endpoint of the trial was PFS, and secondary endpoints
included OS, ORR, DOR, disease control rate (DCR), safety, and
measures of health-related quality of life (HRQoL).

About Tagrisso

Tagrisso is a third-generation, irreversible EGFR tyrosine kinase
inhibitor (TKI) designed to inhibit both EGFR sensitising and EGFR
T790M resistance mutations, with clinical activity against central
nervous system (CNS) metastases. Tagrisso (osimertinib) 40mg and 80mg
once-daily oral tablets have been approved in more than 50 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 and metastatic 1st-line settings, including in
patients with and without CNS metastases, in leptomeningeal
metastases, and in combination with other treatments.

About AstraZeneca in Lung Cancer

AstraZeneca is committed to developing therapies to help every patient
with lung cancer. We have two approved therapies 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 New Oncology as one of AstraZeneca's five 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, 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 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 innovativ...

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