AstraZeneca's Fulvestrant Met Its Primary Endpoint as First-Line Treatment in a Phase III Trial for HR+ Advanced Breast Cancer
May 27 2016 - 7:00AM
Business Wire
AstraZeneca today announced positive results from the Phase III
FALCON trial comparing fulvestrant 500mg to anastrozole 1mg for the
treatment of locally-advanced or metastatic breast cancer, in
postmenopausal women who have not had prior hormonal treatment for
hormone receptor positive (HR+) breast cancer.1
Fulvestrant 500mg demonstrated superiority compared with
anastrozole 1mg in FALCON, and met its primary endpoint of extended
progression-free-survival. The trial showed an adverse event
profile generally consistent with current knowledge of the safety
profile of the medicines.1
Sean Bohen, Executive Vice President, Global Medicines
Development and Chief Medical Officer at AstraZeneca, said: “The
FALCON results bring us closer to offering more and earlier
treatment options to postmenopausal women with HR+ locally-advanced
or metastatic breast cancer; the potential to delay disease
progression is important for these patients as there is currently
no cure. Fulvestrant has over 10 years of clinical evidence and we
are committed to exploring its potential along with the rest of our
outstanding oncology portfolio.”
A full evaluation of the data is ongoing and the results are
expected to be presented at a medical congress in 2016.
Aromatase inhibitors (such as anastrozole) are a standard of
care in first-line treatment for postmenopausal women with advanced
HR+ positive breast cancer.3,4,5
NOTES TO EDITORS
About FALCON
The FALCON (Fulvestrant
and AnastrozoLe COmpared in hormonal
therapy Naïve advanced breast cancer) study is a Phase
III, randomized, double-blind, multicenter trial. The study
compared the anti-tumor effects and tolerability profile of a 500mg
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 been treated previously with any hormonal therapy.1
About Metastatic Breast Cancer (MBC)
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.6,7 Since there is
no cure for metastatic breast cancer, the goal of current treatment
is to delay disease progression.6,8
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
2020.9
About Fulvestrant
Fulvestrant is approved for the treatment of postmenopausal
women with HR+ MBC whose cancer has progressed following
antiestrogen therapy. On 2 March 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.2,10
Fulvestrant represents a hormonal therapy approach that targets
the estrogen receptor (ER). The ER is a key driver of disease
progression.11 Fulvestrant helps to slow tumor growth by blocking
and degrading the ER.2
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
Oncology is a therapeutic area in which AstraZeneca has
deep-rooted heritage. It will be potentially transformational for
the company’s future, becoming the sixth growth platform. Our
vision is to help patients by redefining the cancer treatment
paradigm and one-day eliminate cancer as cause of death. By 2020,
we are aiming to bring six new cancer medicines to patients.
Our broad pipeline of next-generation medicines is focused on
four main disease areas - ovarian, lung, breast, and hematological
cancers. These are being targeted through four key platforms –
immuno-oncology, the genetic drivers of cancer and resistance, DNA
damage repair and antibody drug conjugates.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialization of prescription medicines, primarily for the
treatment of diseases in three main therapy areas - respiratory,
inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology – as well as in infection and
neuroscience. 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.
________________________
References1 In House Data, AstraZeneca Pharmaceuticals
LP. FALCON Clinical Study Protocol. 000-580-937. January 14, 20132
FASLODEX (fulvestrant) Prescribing Information. AstraZeneca
Pharmaceuticals LP, Wilmington, DE3 Rugo H. The breast cancer
continuum in hormone-receptor-positive breast cancer in
postmenopausal women: evolving management options focusing on
aromatase inhibitors. Annals of Oncology. 2007;10.1093:1-12.4
National Cancer Institute. Breast Cancer Treatment (PDQ®)
Healthcare Professionals version. Available Online. Last Updated
February 2, 2016. Last accessed May 18, 2016.5 ARIMIDEX
(anastrozole) Prescribing Information. AstraZeneca Pharmaceuticals
LP, Wilmington, DE6 American Cancer Society. What Is Advanced
Cancer? Atlanta: American Cancer Society; 2014. Available Online.
Last accessed May 2016.7 American Cancer Society. Bone Metastasis.
Atlanta: American Cancer Society; 2014. Available Online. Last
accessed May 2016.8 National Cancer Institute. Breast Cancer
Treatment (PDQ®). Available Online. Last Updated September 25,
2014. Last accessed October 2014.9 CancerMPact.Khapps.com:
ONC-Prevalence of Metastatic Breast Cancer in Women 2014-2020.
Available Online. Last accessed May 18, 2016.10 FDA Approval
Letter. U.S. Food and Drug Administration, Silver Spring, MD11
Osborne et al. Mechanisms of Endocrine Resistance in Breast Cancer.
Annu Rev Med. 2011; 62: 233–247.
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