ASTRAZENECA'S FASLODEX MET PRIMARY ENDPOINT IN FIRST-LINE TREATMENT OF ADVANCED BREAST CANCER

AstraZeneca today announced positive results from the Phase III FALCON trial
comparing Faslodex 500mg (fulvestrant) to Arimidex 1mg (anastrozole) for the
treatment of locally-advanced or metastatic breast cancer, in post-menopausal
women who have not had prior hormonal treatment for hormone-receptor-positive
(HR+) breast cancer.

Faslodex 500mg demonstrated superiority compared with Arimidex 1mg in FALCON,
and met its primary endpoint of extended progression-free survival. The trial
showed an adverse event profile generally consistent with current knowledge of
the safety profile of the medicines.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief
Medical Officer at AstraZeneca, said: "The FALCON results bring us closer to
offering more and earlier treatment options to postmenopausal women with HR+
locally-advanced or metastatic breast cancer; the potential to delay disease
progression is important for these patients as there is currently no cure.
Faslodex has over 10 years of clinical evidence and we are committed to
exploring its potential along with the rest of our outstanding oncology
portfolio."

A full evaluation of the data is ongoing and the results are expected to be
presented at a medical meeting in 2016.

Aromatase inhibitors (such as Arimidex) are the current standard of care in
first-line treatment for postmenopausal women with advanced HR+ breast cancer.i

Faslodex 500mg is approved for the treatment of postmenopausal women with
oestrogen-receptor (ER)-positive locally-advanced or metastatic breast cancer
whose cancer has progressed following anti-oestrogen therapy.ii Most recently,
on 2 March 2016, the US Food and Drug Administration approved Faslodex 500mg, in
combination with palbociclib, for the treatment of women with hormone-receptor
-positive, human-epidermal-growth-factor-receptor 2-negative (HER2-) advanced or
metastatic breast cancer (MBC), whose cancer has progressed after endocrine
therapy.iii

About FALCON

The FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy Naive
advanced breast cancer) trial is a Phase III, randomised, double-blind,
multicentre trial. The trial compared the anti-tumour effects and tolerability
profile of a 500mg dose of Faslodex plus placebo with a 1mg dose of Arimidex
plus placebo, in postmenopausal women with hormone-receptor-positive, locally
-advanced or metastatic breast cancer who have not been treated previously with
any hormonal therapy.

About Advanced breast cancer (ABC)

ABC is the most advanced stage of breast cancer (stage IV), and occurs when
cancer cells have spread beyond the initial tumour site to other parts of the
body outside of the breast. Since there is no cure for ABC, the goal of current
treatment is to delay disease progression.iv

About Faslodex 500mg (fulvestrant)

Faslodex 500mg is indicated for the treatment of postmenopausal women with ER+,
locally-advanced or metastatic breast cancer for disease relapse on or after
adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti
-oestrogen.2

In the US, Faslodex 500mg is also approved, in combination with palbociclib, for
the treatment of US women with HR+, human epidermal growth factor receptor 2
-negative (HER2-) advanced or metastatic breast cancer (MBC), whose cancer has
progressed after endocrine therapy. Faslodex 500mg represents a hormonal therapy
approach that helps to slow tumour growth by blocking and degrading the
oestrogen receptor - a key driver of disease progression.v

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 6 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, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialisation of prescription
medicines, primarily for the treatment of diseases in three main therapy areas -
respiratory, inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology - as well as in infection and
neuroscience. 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

References

i Journal of Clinical Oncology. Endocrine Therapy for Hormone Receptor-Positive
Metastatic Breast Cancer: American Society of Clinical Oncology Guideline.
Available at:
http://jco.ascopubs.org/content/early/2016/05/19/JCO.2016.67.1487.full.pdf+html.
Last accessed 25.05.2016

ii FASLODEX Summary of Product Characteristics. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/h
u 
man (http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Informat
i 
on/human/000540/WC500021174.pdf)
/000540/WC500021174.pdf (http://www.ema.europa.eu/docs/en_GB/document_library/EP
A 
R__Product_Information/human/000540/WC500021174.pdf). Last accessed 25/02/2016

iii FASLODEX full Prescribing Information. AstraZeneca Pharmaceuticals LP,
Wilmington, DE

iv National Cancer Institute. What Is Cancer?: Metastatic Cancer. Available
online at: http://www.cancer.gov/about-cancer/what-is-cancer/metastatic-fact
-sheet. Last accessed 25/04/2016.

v Howell A. Is fulvestrant ("Faslodex") just another selective estrogen receptor
modulator? Int J

Gynecol Cancer. 2006;16 (suppl 2):521-523.

CONTACTS

Media Enquiries
Neil Burrows         UK/Global                 +44 7842 350541
Vanessa Rhodes       UK/Global                 +44 7880 400690
Karen Birmingham     UK/Global                 +44 7818 524012
Jacob Lund           Sweden                    +46 8 553 260 20
Michele Meixell      US                        +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen                            +44 7818 524185
Nick Stone           RIA, CVMD                 +44 7717 618834
Henry Wheeler        Oncology                  +44 7788 354619
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Christer Gruvris     ING, Consensus Forecasts  +44 7827 836825
US
Lindsey Trickett     CVMD, Oncology            +1 240 543 7970
Mitchell Chan        Oncology                  +1 240 477 3771
Dial / Toll-Free                               +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and
Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal



27 May 2016

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