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2018-08-21

AstraZeneca: 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 (http://www.nejm.org/doi/full/10.1056/NEJMoa1713137).

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 |EGFR-TKI comparator |
| |(N=279) |(gefitinib or |
| | |erlotinib)(N=277) |
+--------------------+------------+-----------------------+
|PFS |
+--------------------+------------+-----------------------+
|Number of events |136 (49) |206 (74) |
|(62% maturity) | | |
+--------------------+------------+-----------------------+
|Median PFS |18.9 months |10.2 months (9.6, 11.1)|
|(95%confidence |(15.2, 21.4)| |
|interval [CI]) | | |
+--------------------+------------+-----------------------+
|Hazard ratio (HR |0.46 (0.37, |
|[95% CI]); p-value |0.57); |
| |p < 0.0001 |
+--------------------+------------+-----------------------+
|Objective response |
|rate (ORR) |
+--------------------+------------+-----------------------+
|Response rate (95% |80% (75, 85)|76% (70, 81) |
|CI) | | |
+--------------------+------------+-----------------------+
|Odds ratio (95% CI);|1.3 (0.9, |
|p-value |1.9); |
| |p=0.2421 |
+--------------------+------------+-----------------------+
|Duration of response |
|(DoR) |
+--------------------+------------+-----------------------+
|Median DoR (95% CI) |17.2 months |8.5 months (7.3, 9.8) |
| |(13.8, 22.0)| |
+--------------------+------------+-----------------------+

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
40 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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