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2018-06-09

AstraZeneca: The EU approves Tagrisso for 1st-line treatment of EGFR-mutated non-small cell lung cancer

1st-line Tagrisso offers a potential new standard of care

Today the European Commission has granted marketing authorisation for
Tagrisso (osimertinib) as monotherapy for 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 approval is based on results from the Phase III
FLAURA trial 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 at AstraZeneca, said: "Today's approval is an exciting
advance in bringing a potential new standard of care to patients with
EGFR-mutated NSCLC in the EU. This milestone is also a step forward
for our Company, marking another regional approval for Tagrisso in
the 1st-line setting."

Dr. David Planchard, Associate Professor of Medicine, Head of Thoracic
Group, Gustave Roussy cancer center, France said: "The FLAURA trial
is changing medical practice in the 1st-line treatment of
EGFR-mutated NSCLC. The progression-free survival benefit seen in the
trial is unprecedented for patients with an EGFR mutation, and this
benefit was consistent across all subgroups including in patients
with or without central nervous system metastases. Further, the
preliminary overall survival data, while not statistically
significant at the time of the interim analysis, is promising, with a
37 percent reduction in the risk of death."

The approval follows the positive opinion
(https://www.astrazeneca.com/media-centre/press-releases/2018/tagrisso-re...)
from the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency.

FLAURA efficacy results according to investigator assessment

+----------------+------------+-----------------------+
|Efficacy |Tagrisso |EGFR-TKI comparator |
|parameter |(N=279) |(gefitinib or |
| | |erlotinib)(N=277) |
+----------------+------------+-----------------------+
|Progression-free |
|survival (PFS) |
+----------------+------------+-----------------------+
|Number of events|136 (49) |206 (74) |
|(62% maturity) | | |
+----------------+------------+-----------------------+
|Median PFS (95% |18.9 months |10.2 months (9.6, 11.1)|
|CI) |(15.2, 21.4)| |
+----------------+------------+-----------------------+
|HR (95% CI); p |0.46 (0.37, |
|-value |0.57); |
| |p < 0.0001 |
+----------------+------------+-----------------------+
|Overall survival |
|(OS) |
+----------------+------------+-----------------------+
|Number of |58 (21) |83 (30) |
|deaths, (25% | | |
|maturity) | | |
+----------------+------------+-----------------------+
|Median OS in |NC |NC |
|months (95% CI) | | |
+----------------+------------+-----------------------+
|HR (95% CI); p |0.63 (0.45, |
|-value |0.88); |
| |p=0.0068 |
| |(NS)* |
+----------------+------------+-----------------------+
|Objective |
|response rate |
|(ORR) |
+----------------+------------+-----------------------+
|Response rate |80% (75, 85)|76% (70, 81) |
|(95% CI) | | |
+----------------+------------+-----------------------+
|Odds ratio (95% |1.3 (0.9, |
|CI); p-value |1.9); |
| |p=0.2421 |
+----------------+------------+-----------------------+
|Duration of |
|response (DoR) |
+----------------+------------+-----------------------+
|Median DoR (95% |17.2 months |8.5 months (7.3, 9.8) |
|CI) |(13.8, 22.0)| |
+----------------+------------+-----------------------+

*Not statistically significant at current level of maturity.

Safety data for Tagrisso from the FLAURA, AURA3, AURA and AURA2 trials
were evaluated. Tagrisso was well tolerated, with most adverse
reactions Grade 1 or 2 in severity. In all patients, the most common
adverse reactions were decreased leucocytes (68% [1.5% Grade ?3]),
decreased lymphocytes (67% [7.2% Grade ?3]), decreased platelet count
(54% [1.6% Grade ?3]), diarrhoea (49% [1.2% Grade ?3]), rash (47%
[0.9% Grade ?3]), decreased neutrophils (35% [4.1% Grade ?3]), dry
skin (33% [0.1% Grade ?3]), paronychia (31% [0.3% Grade ?3]),
stomatitis (20% [0.2% Grade ?3]), and pruritus (17% [0.1% Grade ?3]).

In the EU, Tagrisso is already indicated for the treatment of patients
with locally-advanced or metastatic EGFR T790M mutation-positive
NSCLC. Today's approval follows the recent approvals of Tagrisso for
the 1st-line treatment of patients with metastatic EGFR-mutated
(EGFRm) NSCLC in the US, Brazil and the Russian Federation. Tagrisso
is also under regulatory review in Japan for use in the 1st-line
treatment setting with a decision anticipated in the second half of
2018, with other global health authority reviews and submissions
ongoing.

-ENDS-

Notes to Editors

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 four
countries, including the US and EU, 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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