Fulvestrant reduced risk of progression by
20% and extended median progression-free survival beyond
anastrozole
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
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
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
About Fulvestrant
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
About Anastrozole
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.
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 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
References
- 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161008005003/en/
AstraZenecaMichele Meixell, +1 302-885-2677orAbigail Bozarth, +1
302-885-2677
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Aug 2024 to Sep 2024
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Sep 2023 to Sep 2024