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.
- Data will be presented from a study on overcoming PTEN loss-related endocrine therapy resistance through strategic combinations with mTOR, AKT, or MEK inhibitors.
- 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.
- 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.
- 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
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
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. 2231105Last Updated 12/12