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AstraZeneca Announces Subgroup Analysis from FALCON Trial Comparing FASLODEX® (fulvestrant) to ARIMIDEX® (anastrozole)AstraZeneca today announced results from a pre-specified subgroup analysis of the positive Phase III FALCON trial suggesting that treatment effects in terms of progression-free survival (PFS) were largely consistent across the subgroups analyzed with some possible exceptions, including patients with non-visceral disease. The FALCON trial assessed FASLODEX® (fulvestrant) 500 mg compared to ARIMIDEX® (anastrozole) 1 mg in the 1st line endocrine treatment of postmenopausal women who were initially diagnosed with locally-advanced or metastatic breast cancer who had not had prior hormonal treatment for hormone receptor positive (HR+) breast cancer.1 The results, presented during a poster session at the 2016 San Antonio Breast Cancer Symposium (SABCS), showed a decreased risk of progression by 41% (Hazard ratio: 0.592; 95% confidence interval (CI): 0.419-0.837), in women whose disease has not spread to organs within the chest or abdomen (defined as non-visceral disease), when compared with ARIMIDEX.1,2 In this subgroup, median PFS was 22.3 months for FASLODEX vs 13.8 months for ARIMIDEX. In patients with visceral disease, the treatment effect for FASLODEX vs ARIMIDEX was comparable (Hazard ratio: 0.993; 95% CI: 0.740-1.331).1 Serious adverse events (SAEs) in the non-visceral disease subgroup occurred in 11.6% of patients with FASLODEX versus 16.8% of patients with ARIMIDEX. In the visceral disease subgroup, SAEs occurred in 14.3% of patients with FASLODEX vs 10.1% of patients with ARIMIDEX.1 Aromatase inhibitors, such as ARIMIDEX, are the current standard of care in 1st line treatment for postmenopausal women with HR+ advanced breast cancer. 3,4,5 Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "The findings from this subgroup analysis build upon the existing body of clinical evidence for FASLODEX. AstraZeneca is committed to investigating the potential of FASLODEX in the 1st line setting for women with advanced breast cancer alongside the development of new targeted medicines and immunotherapies for women with all types of early and advanced breast cancer." John Robertson, MD, Professor of Surgery, University of Nottingham, Royal Derby Hospital Centre, United Kingdom noted: "This subgroup analysis has identified a cohort of patients with non-visceral disease who may derive even longer disease control from fulvestrant over anastrozole when compared to patients with visceral disease. Data from the FIRST trial, a head-to-head Phase II trial that showed both improved disease control and a survival benefit in favor of fulvestrant corroborate the findings reported in the visceral and non-visceral subgroups in FALCON. Together, these findings indicate that fulvestrant may offer an important treatment option in advanced breast cancer for this population of patients." The FALCON trial met its primary endpoint and revealed a median PFS of 16.6 months in the FASLODEX arm compared to 13.8 months median PFS in the ARIMIDEX arm (Hazard ratio 0.797; 95% CI: 0.637-0.999; p=0.0486). The FALCON data was recently published online in The Lancet and was presented at the 2016 European Society for Medical Oncology meeting.6 The safety and tolerability profile was in line with current experience with FASLODEX and ARIMIDEX. The most commonly reported AEs in the FASLODEX and ARIMIDEX arms were arthralgia (17% vs 10%), hot flashes (11% vs 10%), and nausea (11% vs 10%), respectively.1,6 AstraZeneca is pursuing a label extension with US regulatory authorities to include the FALCON results in the FASLODEX label. FASLODEX is currently approved as a monotherapy in the US for the treatment of HR+ metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.7 ARIMIDEX is currently approved in the US for the first-line treatment of postmenopausal women with HR+ or hormone receptor unknown locally advanced or metastatic breast cancer. ARIMIDEX is also approved for the treatment advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.5 Important Safety Information About FASLODEX Contraindications
Risk of Bleeding
Hepatic Impairment
Injection Site Reaction
Embryo-Fetal Toxicity and Lactation
Immunoassay Measurement of Serum Estradiol
Adverse Reactions Monotherapy
Combination Therapy
Combination Therapy
Please see full Prescribing Information with Patient Information. Important Safety Information About ARIMIDEX
Approved Uses for ARIMIDEX ARIMIDEX is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer. ARIMIDEX is approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen. Patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX. For more information, see your doctor. Please see full Prescribing Information. NOTES TO EDITORS About FALCON The FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy Naive advanced breast cancer) study is a Phase III, randomized, double-blind, multicenter trial. The study compared the efficacy and tolerability profile of a 500 mg dose of FASLODEX plus placebo with a 1 mg dose of ARIMIDEX plus placebo, in postmenopausal women with hormone receptor-positive, locally advanced or metastatic breast cancer, who have not had prior hormonal therapy.8,9 The FALCON trial was designed, based on positive results from the Phase II FIRST trial, which demonstrated a greater median overall survival (nearly six months) with FASLODEX, when compared to ARIMIDEX.9 About Advanced Breast Cancer or Metastatic Breast Cancer (ABC/MBC) Advanced/metastatic breast cancer refers to Stages III and IV breast cancer. Stage III disease may be referred to as locally advanced breast cancer. MBC is the most advanced stage of breast cancer (stage IV), and occurs when cancer cells have spread beyond the initial tumor site to other parts of the body outside of the breast. Since there is no cure for metastatic breast cancer, the goal of current treatment is to delay disease progression.10,11,12 It is estimated that in 2016, there will be approximately 151,000 women in the US living with MBC, and this number is projected to increase to approximately 160,000 by the year 2020.13 About FASLODEX (fulvestrant) FASLODEX is approved for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy. On March 2, 2016, the US Food and Drug Administration (FDA) approved FASLODEX, in combination with palbociclib, for the treatment of US women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) advanced or metastatic breast cancer (MBC), whose cancer has progressed after endocrine therapy.7,14 FASLODEX represents a hormonal therapy approach that targets the estrogen receptor (ER). The ER is a key driver of disease progression. FASLODEX helps to slow tumor growth by blocking and degrading the ER.7,15 About ARIMIDEX (anastrozole) ARIMIDEX is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer. ARIMIDEX is approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen. Patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX.5 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 hematology. 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 personalized 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 commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter (News - Alert) @AstraZenecaUS. References
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