ASTRAZENECA

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 (F ulvestrant and A nastrozoL e CO mpared in hormonal therapy N aïve 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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