AstraZeneca to Present Key New Data for Hormone Receptor-Positive Metastatic Breast Cancer at the 35th CTRC-AACR Annual San

  AstraZeneca to Present Key New Data for Hormone Receptor-Positive Metastatic
  Breast Cancer at the 35th CTRC-AACR Annual San Antonio Breast Cancer
  Symposium

Business Wire

WILMINGTON, Del. -- December 04, 2012

AstraZeneca (NYSE: AZN) today announced the presentation of important new data
from studies of FASLODEX^® (fulvestrant) Injection at the 2012 CTRC-AACR San
Antonio Breast Cancer Symposium taking place from 4-8 December at the Henry B.
Gonzalez Convention Center, San Antonio, Texas. This will include final
analysis of overall survival from the Phase III CONFIRM trial (COmparisoN of
Faslodex In Recurrent or Metastatic breast cancer) comparing fulvestrant 500
mg vs 250 mg.

FASLODEX 500 mg is indicated for the treatment of hormone receptor-positive
metastatic breast cancer in postmenopausal women with disease progression
following antiestrogen therapy. FASLODEX is contraindicated in patients with
known hypersensitivity to the drug or to any of its components.
Hypersensitivity reactions, including urticaria and angioedema have been
reported in association with FASLODEX. Please see additional Important Safety
Information below.^1

“The study data and research findings that will be presented are a further
addition to AstraZeneca’s ongoing commitment to the continued study and
evaluation of treatment options for metastatic breast cancer. While some of
the data and research are investigational, it highlights AstraZeneca’s ongoing
pursuit to developing and optimizing breast cancer treatments for patients,”
said Yuri Rukazenkov, MD, Medical Science Director, AstraZeneca.

Highlighted study results to be presented:

  *Final overall survival analysis of CONFIRM, a Phase III, randomized,
    double-blind, parallel-group, multicenter trial comparing FASLODEX 500 mg
    (n=362) and 250 mg (n=374) in postmenopausal women with estrogen
    receptor-positive advanced breast cancer whose disease progressed or
    recurred following prior endocrine therapy, will be presented by Angelo Di
    Leo, MD, Head of the Sandro Pitigliani Medical Oncology Unit. Study
    results will also be featured in a SABCS press briefing.

Final analysis of overall survival for the Phase III CONFIRM trial:
fulvestrant 500 mg versus 250 mg. (Abstract #S1-4). SABSC press briefing,
Wednesday, December 5, 7:30 AM CDT. Oral presentation, General Session 1,
Wednesday, December 5, 9:15 AM CDT, Exhibit Hall D.

  *Data will be presented from a study on overcoming PTEN loss-related
    endocrine therapy resistance through strategic combinations with mTOR,
    AKT, or MEK inhibitors.

Overcoming endocrine therapy resistance related to PTEN loss by strategic
combinations with mTOR, AKT, or MEK inhibitors. (Abstract #PD01-01). Poster
Discussion 1, Endocrine Resistance, Wednesday, December 5, 5:00 – 7:00 PM CDT,
Ballroom A.

  *Results from a meta-analysis of the EFECT and SoFEA studies of fulvestrant
    and exemestane in metastatic breast cancer patients with acquired
    resistance to non-steroidal aromatase inhibitors. The SoFEA trial is a
    Phase III study evaluating safety and efficacy of fulvestrant plus
    concomitant anastrozole in postmenopausal women with advanced hormone
    receptor-positive breast cancer compared with fulvestrant or exemestane
    alone. Results of the EFECT trial, a randomized, double-blind,placebo
    controlled, multicenter phase III trial of fulvestrant versus exemestane
    in postmenopausal women with hormone receptor-positive advanced breast
    cancer progressing or recurring after nonsteroidal aromatase inhibitors,
    were published in 2008 in the Journal of Clinical Oncology.

Fulvestrant vs exemestane for treatment of metastatic breast cancer in
patients with acquired resistance to non-steroidal aromatase inhibitors – a
meta-analysis of EFECT and SoFEA (CRUKE/03/021 and CRUK/09/007). (Abstract
#P2-14-01). Poster Session 2, Treatment: Endocrine Therapy - Advanced Disease,
Thursday, December 6: 7:00 - 9:00 AM CDT: Exhibit Halls A – B.

  *First results from the UNICANCER CARMINA 02 French Trial, a randomized
    Phase II neoadjuvant trial evaluating anastrozole and fulvestrant in
    post-menopausal estrogen receptor-positive, HER2-negative breast cancer
    will be presented. The UNICANCER CARMINA study focuses on the neo-adjuvant
    treatment of operable breast cancer in postmenopausal women with stage II
    or stage III disease.

A randomized Phase II neoadjuvant trial evaluating anastrozole and fulvestrant
efficiency for post-menopausal ER-positive, HER2-negative Breast Cancer
patients: first results of the UNICANCER CARMINA 02 French trial. (Abstract
#PD07-04). Poster Discussion 7, Neoadjuvant Endocrine Therapy &
Bisphosphonates, Friday, December 7: 7:00 - 9:00 AM CDT: Ballroom A.

Important Safety Information About FASLODEX

  *FASLODEX is contraindicated in patients with known hypersensitivity to the
    drug or to any of its components. Hypersensitivity reactions, including
    urticaria and angioedema have been reported in association with FASLODEX
  *Because FASLODEX^® (fulvestrant) Injection is administered
    intramuscularly, it should be used with caution in patients with bleeding
    diatheses, thrombocytopenia, or in patients on anticoagulants
  *FASLODEX is metabolized primarily in the liver. A 250-mg dose is
    recommended in patients with moderate hepatic impairment. FASLODEX has not
    been evaluated in patients with severe hepatic impairment (Child-Pugh
    Class C)
  *Fetal harm can occur when administered to a pregnant woman. Women should
    be advised of the potential hazard to the fetus and to avoid becoming
    pregnant while receiving FASLODEX
  *The most common, clinically significant adverse reactions occurring in ≥5%
    of patients receiving FASLODEX were: injection site pain, nausea, bone
    pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot
    flash, vomiting, anorexia, asthenia, musculoskeletal pain, cough, dyspnea,
    and constipation
  *Increased hepatic enzymes (ALT, AST, ALP) occurred in >15% of FASLODEX
    users and were non dose-dependent

Indication for FASLODEX^® (fulvestrant) Injection

FASLODEX is indicated for the treatment of hormone receptor-positive
metastatic breast cancer in postmenopausal women with disease progression
following antiestrogen therapy.

Please see full Prescribing Information for FASLODEX.

Important Safety Information About ARIMIDEX

  *ARIMIDEX is only for postmenopausal women. ARIMIDEX can cause fetal harm
    when administered to a pregnant woman. Before starting treatment with
    ARIMIDEX, pregnancy must be excluded. ARIMIDEX is contraindicated in
    patients with demonstrated hypersensitivity to ARIMIDEX or any of its
    excipients. Observed reactions include anaphylaxis, angioedema, and
    urticaria. (see CONTRAINDICATIONS section of full Prescribing Information)
  *In women with preexisting ischemic heart disease 465/6186 (7.5%), an
    increased incidence of ischemic cardiovascular events occurred with
    ARIMIDEX (17%) vs tamoxifen (10%). In this patient population, angina
    pectoris was reported in 25/216 (11.6%) vs 13/249 (5.2%) and myocardial
    infarction was reported in 2/216 (0.9%) vs 8/249 (3.2%) in patients
    receiving ARIMIDEX and tamoxifen, respectively
  *Compared to baseline, ARIMIDEX showed a mean decrease in both lumbar spine
    and total hip bone mineral density. Tamoxifen showed a mean increase in
    these measurements. Nine percent of patients receiving ARIMIDEX had an
    elevated serum cholesterol vs 3.5% of patients receiving tamoxifen
  *Common side effects seen with ARIMIDEX vs tamoxifen in the early breast
    cancer trial after 5 years of treatment include hot flashes (36% vs 41%),
    joint disorders (including arthritis, arthrosis, arthralgia) (36% vs 29%),
    asthenia (19% vs 18%), mood disturbances (19% vs 18%), pain (17% vs 16%),
    pharyngitis (14% vs 14%), nausea and vomiting (13% vs 12%), rash (11% vs
    13%), depression (13% vs 12%), hypertension (13% vs 11%), osteoporosis
    (11% vs 7%), peripheral edema (10% vs 11%), lymphedema (10% vs 11%), back
    pain (10% vs 10%), insomnia (10% vs 9%), and headache (10% vs 8%).
    Fractures, including fractures of the spine, hip, and wrist, occurred more
    often with ARIMIDEX vs tamoxifen (10% vs 7%)
  *In the advanced breast cancer studies, the most common (occurring with an
    incidence of >10%) side effects occurring in women taking ARIMIDEX
    included hot flashes, nausea, asthenia, pain, headache, back pain, bone
    pain, increased cough, dyspnea, pharyngitis, and peripheral edema. Joint
    pain/stiffness has been reported in association with the use of ARIMIDEX
  *Clinical and pharmacokinetic results suggest that tamoxifen should not be
    administered with ARIMIDEX. Estrogen-containing therapies should not be
    used with ARIMIDEX as they may diminish its pharmacologic action

Indications for ARIMIDEX^® (anastrozole) Tablets

ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with
hormone receptor-positive early breast cancer.

ARIMIDEX is indicated for the first-line treatment of postmenopausal women
with hormone receptor-positive or hormone receptor-unknown locally advanced or
metastatic breast cancer and for the treatment of advanced breast cancer in
postmenopausal women with disease progression following tamoxifen therapy.
Patients with estrogen receptor-negative disease and patients who did not
respond to previous tamoxifen therapy rarely responded to ARIMIDEX.

Please see full Prescribing Information for ARIMIDEX.

NOTES TO EDITORS

About Metastatic Breast Cancer

Metastatic breast cancer occurs when cancer cells spread beyond the initial
tumor site to other parts of the breast or body; it is the most advanced stage
of breast cancer (stage four).^2,3 Metastatic breast cancer may be diagnosed
as an initial diagnosis, as a distant recurrence after treatment of early
breast cancer, or as a progression of earlier stage disease.^4,5 There is no
cure for metastatic breast cancer; the goal of treatment is to delay the
progression of the cancer.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a
primary focus on the discovery, development and commercialization of
prescription medicines for gastrointestinal, cardiovascular, neuroscience,
respiratory and inflammation, oncology and infectious disease. AstraZeneca
operates in over 100 countries and its innovative medicines are used by
millions of patients worldwide.

For more information about AstraZeneca in the United States or our AZ&Me™
Prescription Savings programs, please visit: www.astrazeneca-us.com or call
1-800-AZandMe (292-6363).

^1 Prescribing Information for FASLODEX. AstraZeneca Pharmaceutical LP,
Wilmington, DE.
^2 National Cancer Institute. Treatment Option Overview, Patient Version.
Available online. Last accessed July 26, 2012.
^3 National Cancer Institute. Metastatic Cancer: Questions and Answers.
Available online. Last accessed July 26, 2012.
^4 Dawood S, Broglio K, Ensor J, Hortobagyi GN, Giordano SH. Survival
differences among women with de novo stage IV and relapsed breast cancer.
Annals Oncol. 2010;21:2169-2174.
^5 American Cancer Society. Treatment of invasive breast cancer, by stage.
Last revised: August 23, 2012. Available Online. Last accessed September 17,
2012.

2231105
Last Updated 12/12

Contact:

AstraZeneca
Media Inquiries US
Rachelle Benson +1 302 885 5853 mob: +1 302 559 5861
 
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