WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced data from the Phase III FALCON trial demonstrating superior median progression-free survival (PFS) for fulvestrant 500mg compared to anastrozole 1mg in the 1st line treatment of postmenopausal women with locally-advanced or metastatic breast cancer, who have not had prior hormonal treatment for hormone receptor positive (HR+) breast cancer.1 The primary endpoint was PFS and the FALCON trial enrolled 462 patients.
The results, announced at the 2016 European Society for Medical Oncology (ESMO) Congress, show that the median PFS was 2.8 months longer with fulvestrant than anastrozole (Hazard ratio 0.797; 95% confidence interval: 0.637-0.999; p=0.0486). The median PFS was 16.6 months in the fulvestrant arm, compared with 13.8 months in the anastrozole arm.1 Aromatase inhibitors, such as anastrozole, are the current standard of care in 1st line treatment for postmenopausal women with hormone-receptor positive (HR+) advanced breast cancer. 2,3,4
Professor Matthew Ellis, Principal Investigator of the FALCON trial, said: “These data document a benefit for fulvestrant in delaying disease progression as a 1st line therapy, an important goal for women with metastatic breast cancer. The results are supported by a previous trial, which also showed an advantage for fulvestrant over anastrozole. The results are clinically meaningful and suggest that fulvestrant could be used as 1st line therapy for women with advanced breast cancer.”
The safety and tolerability profile was in line with current experience with fulvestrant and anastrozole. The most commonly reported adverse events in the fulvestrant and anastrozole arms were arthralgia (16.7% vs 10.3%), hot flashes (11.4% vs 10.3%), and nausea (10.5% vs 10.3%), respectively.1
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Fulvestrant has over 10 years of clinical evidence to support its use, and we are continuing to evaluate its full potential in advanced breast cancer, where we believe patient need is currently the greatest. AstraZeneca has a long, rich heritage in breast cancer research, and we remain committed to investigating innovative potential medicines for the treatment of women with all types of advanced disease.”
Given the FALCON trial results, AstraZeneca is now in discussions with US regulatory authorities about a planned regulatory submission for a potential label extension.
NOTES TO EDITORS
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 fulvestrant plus placebo with a 1 mg dose of anastrozole plus placebo, in postmenopausal women with hormone receptor-positive, locally advanced or metastatic breast cancer, who have not had prior hormonal therapy.5,6
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 fulvestrant, when compared to anastrozole.6
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.7,8,9
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 2020.10
Fulvestrant 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 fulvestrant, 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. 11,12
Fulvestrant represents a hormonal therapy approach that targets the estrogen receptor (ER). The ER is a key driver of disease progression. Fulvestrant helps to slow tumor growth by blocking and degrading the ER. 11,13
Anastrozole is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer. Anastrozole 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 anastrozole.4
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.
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 therapy areas – Respiratory and Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The company is also active in inflammation, infection and neuroscience through numerous collaborations. 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
- Ellis M J, Bondarenko I M, Trishkina E, et al. FALCON: A phase III randomised trial of fulvestrant 500 mg vs anastrozole for hormone receptor-positive advanced breast cancer. Late Breaking Abstract_LBA14_PR [Oral Presentation]. Presented at the European Society for Medical Oncology (ESMO) Congress, 7-11 October 2016. Copenhagen, Denmark.
- Rugo H. The breast cancer continuum in hormone-receptor-positive breast cancer in postmenopausal women: evolving management options focusing on aromatase inhibitors. Ann Oncol. 2007;10.1093:1-12. Accessed September 2016.
- National Cancer Institute. Breast Cancer Treatment (PDQ®) Healthcare Professionals version. Available Online. Last Updated February 2, 2016. Accessed September 2016.
- ARIMIDEX (anastrozole) Prescribing Information. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
- A Global Study to Compare the Effects of Fulvestrant and Anastrozole in a Subset of Patients With Breast Cancer. (FALCON) ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Available Online NLM Identifier: NCT01602380 Accessed September 2016.
- Ellis MJ, Llombart-Cussac A, Feltl D, et al. Fulvestrant 500 mg Versus Anastrozole 1 mg for the First-Line Treatment of Advanced Breast Cancer: Overall Survival Analysis From the Phase II FIRST Study. J Clin Oncol. 2015 Nov 10;33(32):3781-7. Accessed September 2016.
- Cleveland Clinic. Diseases and Conditions: Breast Cancer. Available Online. Last Updated September 5, 2013. Accessed September 2016.
- Mayo Clinic. Breast Cancer Diagnosis. Available Online. Last Updated August 16, 2016. Accessed September 2016.
- American Cancer Society. What Is Advanced Cancer? Atlanta: American Cancer Society; 2014. Available online. Accessed September 2016.
- CancerMPact.Khapps.com: ONC-Prevalence of Metastatic Breast Cancer in Women 2014-2020. Last accessed September 2016.
- FASLODEX full Prescribing Information. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
- FDA Approval Letter. U.S. Food and Drug Administration, Silver Spring, MD.
- Mehta RS, Barlow WE, Albain KS, et al. Combination anastrozole and fulvestrant in metastatic breast cancer. N Engl J Med. 2012 Aug 2;367(5):435-44.