New data from AstraZeneca's FASLODEX studies on breast cancer to be presented at SABSC

AstraZenecaDec 5 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.

"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>

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.