Faslodex Demonstrates Progression-Free Survival Advantage in 1st Line Advanced Breast Cancer

Faslodex reduces risk of progression by 20% and extends median
progression-free survival beyond Arimidex

CAMBRIDGE, England–(BUSINESS WIRE)–AstraZeneca today announced data from the Phase III FALCON trial
demonstrating superior median progression-free survival (PFS) for Faslodex
(fulvestrant) 500mg compared to Arimidex (anastrozole) 1mg in the
1st line treatment of postmenopausal women with locally-advanced or
metastatic breast cancer. The primary endpoint was PFS, and the FALCON
trial enrolled 462 patients.¹

The results, announced at the 2016 European Society for Medical Oncology
(ESMO) Congress, show that median PFS was 2.8 months longer with
fulvestrant than anastrozole (Hazard ratio: 0.797; 95% confidence
interval: 0.637-0.999; p=0.0486). The median PFS was 16.6 months in the
fulvestrant arm compared, with 13.8 months in the anastrozole arm.¹
Aromatase inhibitors, such as anastrozole, are the current standard of
care in 1st line treatment for postmenopausal women with
hormone-receptor positive (HR+) advanced breast cancer.^2,3,4

Professor Matthew Ellis, Principal Investigator of the FALCON trial,
said: “These data document a benefit for fulvestrant in delaying disease
progression as a 1st line therapy, an important goal for women with
metastatic breast cancer. The results are supported by a previous trial
which also showed an advantage for fulvestrant over anastrozole. The
results are clinically meaningful and suggest that fulvestrant could be
a 1st line therapy for women with advanced breast cancer.”

The safety and tolerability profile was in line with current experience
with fulvestrant and anastrozole. The most commonly reported adverse
events (AEs) in the fulvestrant and anastrozole arms were arthralgia
(16.7% vs. 10.3%), hot flush (11.4% vs. 10.3%), and nausea (10.5% vs.
10.3%), respectively.

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: “Fulvestrant has over 10
years of clinical evidence to support its use, and we are continuing to
evaluate its full potential in advanced breast cancer, where we believe
patient need is currently the greatest. AstraZeneca has a long, rich
heritage in breast cancer research, and we remain committed to
investigating innovative potential medicines for the treatment of women
with all types of advanced disease.”

Following the results of the FALCON trial, AstraZeneca is now in
discussion with regulatory authorities before making a decision about a
regulatory submission for a potential label extension.

-ENDS-

For more information on AstraZeneca at ESMO, please visit www.twitter.com/AstraZeneca.

NOTES TO EDITORS

About FALCON

The FALCON (Fulvestrant and AnastrozoLe COmpared
in hormonal therapy Naïve advanced breast cancer) trial is a
Phase III, randomised, double-blind, multicentre trial. It compared the
antitumour effects and tolerability profile of a 500mg dose of
fulvestrant plus placebo with a 1mg dose of anastrozole plus placebo, in
postmenopausal women with HR+, locally-advanced or metastatic breast
cancer who had not been treated previously with any hormonal therapy.

The FALCON trial was designed on the basis of positive results from the
Phase II FIRST trial, which demonstrated a median overall survival
nearly six months longer with fulvestrant compared to anastrozole.⁴

About Advanced Breast Cancer

Advanced/metastatic breast cancer refers to Stages III and IV breast
cancer. Stage III disease may be referred to as locally-advanced breast
cancer. Metastatic breast cancer 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 the breast. Since
there is no cure for the disease, the goal of current treatment is to
delay disease progression.⁵

About Fulvestrant

Fulvestrant is indicated for the treatment of postmenopausal women with
oestrogen receptor-positive (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, fulvestrant is also approved, in combination with
palbociclib, for the treatment of women with HR+, HER2- advanced or
metastatic breast cancer, whose cancer has progressed after endocrine
therapy.³ Fulvestrant represents a hormonal therapy approach
that helps to slow tumour growth by blocking and degrading the oestrogen
receptor – a key driver of disease progression.^3,6

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
therapy areas – Respiratory & Autoimmunity, Cardiovascular & Metabolic
Diseases, and Oncology. The Company is also active in inflammation,
infection and neuroscience through numerous collaborations. 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.

Intended audiences

This press release is issued from AstraZeneca Corporate Headquarters in
Cambridge, UK and is intended to provide information about our global
business. Please be aware that information relating to the approval
status and labels of approved products may vary from country to country,
and a country-specific press release on this topic may have been issued
in the countries where AstraZeneca conducts business.

References

1. Ellis M J, et al. FALCON: A phase III randomised trial of
fulvestrant 500 mg vs. anastrozole for hormone receptor-positive
advanced breast cancer. Late Breaking Abstract_LBA14_PR [Oral
Presentation]. Presented at the European Society for Medical Oncology
(ESMO) Congress, 7-11 October 2016. Copenhagen, Denmark.

2. Faslodex Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000540/WC500021174.pdf.
Last accessed September 2016.

3. Faslodex full Prescribing Information. AstraZeneca Pharmaceuticals
LP, Wilmington, DE.

4. Ellis MJ, et al. Fulvestrant 500 mg versus anastrozole 1mg for
the first-line treatment of advanced breast cancer: overall survival
analysis from the phase II ‘FIRST’ study. J Clin Oncol. [Online]
Available at: http://jco.ascopubs.org/content/early/2015/09/14/JCO.2015.61.5831.abstract.
Last accessed September 2016. doi: 10.1200/JCO.2015.61.5831.

5. 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 September 2016.

6. Howell A. Is fulvestrant (“Faslodex”) just another selective estrogen
receptor modulator? Int J Gynecol Cancer. 2006;16 (suppl
2):521-523.

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