New Faslodex(TM) (Fulvestrant) Data Fill 'Treatment Gap' for Women With Advanced Breast Cancer

San Antonio, Texas (ots/PRNewswire) -

- First Randomised Phase III Trial in Advanced Breast Cancer to
Demonstrate That Endocrine Options Show Favourable Clinical Activity
Post NSAI, Even in Patients With Visceral Involvement

For Health Professional Press Only

FOR INTERNATIONAL JOURNALISTS - NOT FOR US MEDIA

AstraZeneca (NYSE:AZN) today announced the first results from a
major clinical trial, EFECT (Evaluation of Faslodex vs Exemestane
Clinical Trial), at the annual San Antonio Breast Cancer Symposium
(SABCS).(1) The data confirm that FASLODEX(TM) (fulvestrant) - an
oestrogen receptor antagonist, and the first of a new type of
endocrine therapy - is a valuable treatment option for women with
hormone-receptor positive (HR+) advanced breast cancer. EFECT is the
first clinical trial to explore the use of 'Faslodex' in
postmenopausal women who have progressed or recurred after treatment
with non-steroidal aromatase inhibitor (NSAI) therapy.

Tamoxifen, previously considered the standard of care for
postmenopausal women with HR+ breast cancer, has been displaced in
recent years by the more effective and better tolerated aromatase
inhibitors (AIs), in both advanced breast cancer and, increasingly,
in women at earlier stages of the disease. This has resulted in a
'treatment gap', with a need for physicians to have proven
therapeutic options for women who have progressed or recurred on NSAI
therapy, to ensure that treatment goals can continue to be achieved.

Dr Stephen Chia, Assistant Professor of Medicine, British Columbia
Cancer Agency - Vancouver Cancer Centre commented, "The primary goal
of treatment for advanced breast cancer is to slow or halt the
progression of the disease without compromising a woman's quality of
life. Until recently, treatment options for women progressing or
recurring after NSAI therapy were uncertain due to the lack of
clinical data in this setting. As more women continue to receive AIs
earlier in the treatment sequence, EFECT provides the first
large-scale study to examine an alternative endocrine option for this
important patient population."

EFECT was designed to examine whether 'Faslodex' was able to
extend the time to progression (TTP) in advanced breast cancer
patients who had already received NSAI therapy. The 693 women
participating in the double-blind phase III trial came from 138
centres in 15 countries, making it one of the largest advanced breast
cancer studies in this patient population. Patients were randomised
to receive either 'Faslodex' via intramuscular injection loading dose
regimen (500 mg day one; 250 mg days 14 and 28, and every 28 days
thereafter), or exemestane, a steroidal AI, 25mg tablets once daily
in a double-blind, double-dummy design.

At the time of analysis, 288 patients (82.1%) receiving the
'Faslodex' regimen had progressed compared with 299 (87.4%) receiving
exemestane with a median TTP of 3.7 months in both groups (HR: 0.963;
95% CI 0.819 - 1.133; p=0.6531).

One of the most encouraging results from EFECT is the Clinical
Benefit (CB) rate, which includes both responding patients and those
in whom the disease remains stable for at least six months. Long-term
disease stabilisation is known to be as beneficial to the patient in
terms of overall survival as achieving a complete or partial
response.(2,3) Despite a majority of evaluable patients (67%) having
visceral metastases - recognised by clinicians as a difficult to
treat population - CB rates reached over 30% ('Faslodex' 32.2% vs.
exemestane 31.5%). This makes EFECT the first randomised phase III
trial to demonstrate that endocrine options show favourable clinical
activity post NSAI, even in a certain proportion of patients with
visceral involvement.

Furthermore, the EFECT data confirm previous studies(4,5) that
show 'Faslodex' is potentially effective and produces durable
responses in the advanced breast cancer setting, with a median
duration of CB of 9.3 months for 'Faslodex' vs. 8.3 months for
exemestane (retrospective analysis, no statistical analysis
performed).

"The EFECT data are extremely valuable to clinicians, as they
provide a robust foundation upon which treatment decisions can be
made in this growing patient population,' added Dr Chia. 'They also
confirm fulvestrant as an important additional endocrine option in
the overall treatment sequence, particularly as it has shown
promising Clinical Benefit rates in a poor prognosis population."

Additional compliance benefits for 'Faslodex'

As a once-monthly intramuscular injection, administered by a nurse
or physician, 'Faslodex' offers an alternative to oral, once-daily
tablets in the advanced breast cancer setting. A recent study showed
that approximately 50% of these patients admitted they sometimes
forgot, or chose not to

take their current oral medication.(6) This study also indicated
that, from the patients' perspective, while the potential for
non-adherence was a major disadvantage of oral treatment, adherence
and convenience were the two main points of preference for an
injection rather than a tablet.

"A benefit of a once-a-month injection is that it provides women
with a greater period of freedom from thinking about their cancer and
the treatment needed for it," said Dr Stephen Chia. "It also provides
them with reassurance of regular contact with their doctor or nurse.
Indeed for some women, once-a-month visits may be a less frequent
reminder of their illness than a daily tablet - and we as physicians
are assured they are getting the full benefit from treatment."

Cost effectiveness of 'Faslodex' - additional new data

Understanding the cost effectiveness of different sequencing
options remains an important consideration when optimising breast
cancer treatment. New data from a health economic model, also
presented today at SABCS, show that the 'Faslodex' approved dose (250
mg / month), when used as second- or third-line therapy versus a
treatment sequence without 'Faslodex', offers a cost effective
addition to the overall treatment sequence in advanced breast
cancer.(7) By introducing an additional endocrine agent in the
treatment sequence, patients can delay or reduce the need for often
toxic and expensive chemotherapy.

Future potential of 'Faslodex' in advanced breast cancer

EFECT is one of several major trials ongoing with 'Faslodex' to
fully define its optimal role and place in the treatment of hormone
receptor-positive breast cancer. This includes investigating
'Faslodex' at higher doses and in combination with other treatments.
Because of its unique mechanism of action, 'Faslodex' is an ideal
candidate for combination therapy, both with other endocrine agents
such as 'Arimidex' (anastrozole) and with novel agents. This
potential was supported today by the initial results from a
pre-clinical investigation of 'Falsodex' and AvastinTM (bevacizumab)
in combination, which demonstrated a marked suppression of breast
tumour growth in vivo.

Notes to Editors

- 'Faslodex' is indicated for the treatment of postmenopausal
women with oestrogen receptor positive, locally advanced or
metastatic breast cancer for disease relapse on or after adjuvant
antioestrogen therapy or disease progression on therapy with an
antioestrogen.

- 'Faslodex' works by finding oestrogen receptors in the cells and
binding to them. In doing so, it blocks oestrogen from binding to
them. The binding of 'Faslodex' also causes the receptors to change
shape and increases the rate at which they are degraded. 'Faslodex'
is given once a month as an intramuscular injection into the buttock.

Breast cancer

- Breast cancer is the most common cancer affecting women. More
than 1,150,000 new cases are diagnosed each year, and there are more
than 400,000 deaths from the disease annually.(8) Approximately 20%
of all women diagnosed with breast cancer have advanced disease
(stage IV), where the cancer has spread to other parts of the body.
The average period of survival for women with metastatic disease is
18-24 months, but this can vary widely between individual
patients.(9)

AstraZeneca

- AstraZeneca is a major international healthcare business engaged
in the research, development, manufacture and marketing of
prescription pharmaceuticals and the supply of healthcare services.
It is one of the world's leading pharmaceutical companies with
healthcare sales of US$23.95 billion and leading positions in sales
of gastrointestinal, cardiovascular, neuroscience, respiratory,
oncology and infection products. AstraZeneca is listed in the Dow
Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For further information, please visit our website
www.astrazenecapressoffice.com or contact:

References

1. Gradishar W, Chia S, Piccart M, on behalf of the EFECT writing
committee et al. Fulvestrant versus exemestane following prior
non-steroidal aromatase inhibitor therapy: first results from EFECT,
a randomized, phase III trial in postmenopausal women with advanced
breast cancer. Oral presentation 12 at SABCS, 15 December 2006.

2. Robertson JFR, Williams MR, Todd J et al. Factors predicting
the response of patients with advanced breast cancer to endocrine
(Megace) therapy. Eur J Cancer Clin Oncol 1989; 23 (1): 469-475.

3. Howell A, Mackintosh J, Jones M et al. The definition of the
'no change' category in patients treated with endocrine therapy and
chemotherapy for advanced carcinoma of the breast. Eur J Cancer &
Clin Oncol 1988; 24 (10): 1567-1572.

4. Robertson JFR, Osborne CK, Howell A et al. Fulvestrant versus
anastrozole for the treatment of advanced breast carcinoma for
postmenopausal women: A prospective combined analysis of two
multicenter trials. Cancer 2003; 98 (2): 229-238.

5. Mauriac L, Pippen JE, Quaresma Albano J, et al. Fulvestrant
(Faslodex(TM)) versus anastrozole for the second-line treatment of
advanced breast cancer in subgroups of postmenopausal women with
visceral and non-visceral metastases: combined results from two
multicentre trials. European Journal of Cancer 2003;39:1228-33.

6. Fallowfield L, Atkins L, Catt S et al. Patients' preference for
administration of endocrine treatments by injection or tablets:
Results from a study of women with breast cancer. Ann Oncol
2006;17:205-10.

7. Cameron DA, Camidge DR, Gait CF, Hirsch MW. Fulvestrant in the
treatment of hormone receptor-positive advanced breast cancer - a
cost-effective addition to the treatment sequence. Poster
presentation at SABCS, 16 December 2006.

8. Ferlay J, Bray F, Pisani P, et al. GLOBOCAN 2002: Cancer
Incidence, Mortality and Prevalence Worldwide IARC CancerBase No. 5.
version 2.0, IARCPress, Lyon, 2004.

9. National Institute for Clinical Excellence (NICE). Guidance on
cancer services. Improving outcomes in breast cancer. Manual update
(www.nice.org.uk ).

Rückfragehinweis:
Lynn Grant, Global PR Director, Breast Cancer, AstraZeneca, Mob:
+44-(0)-7715-484-917, Email: [email protected], Fiona
Robertson, Account Director, Shire Health, Mob: +44-(0)-781-241-4434,
Email: [email protected]

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