FASLODEX® (fulvestrant) significantly improves overall survival for women with hormone-receptor positive breast cancer compared to ARIMIDEX® (anastrozole)

Friday, 12 December 2014

The latest findings presented today at the 2014 San Antonio Breast Cancer Symposium (SABCS) show that investigational first-line treatment with fulvestrant resulted in a significant improvement in overall survival (OS) of 5.7 months, compared with anastrozole in post- menopausal patients with hormone-receptor positive (HR+) locally advanced or metastatic breast cancer.1

These latest OS (a secondary endpoint) results from the Phase II randomized, open-label FIRST (Fulvestrant fIRst-line Study comparing endocrine Treatments) study at a median follow-up of 48.8 months, show an increase in median OS of 5.7 months for fulvestrant compared to anastrozole (54.1 months vs. 48.4 months respectively) and a 30% reduction in the risk of death (HR 0.70; 95% CI 0.50, 0.98; p=0.041). Furthermore, this OS treatment effect was generally consistent irrespective of patient age, progesterone-receptor status, presence of visceral disease or prior hormone or chemotherapy (pre-defined sub-groups).1

The safety and tolerability profile remained consistent with previous findings, with both treatment arms being well tolerated (SAEs; 23.8% for fulvestrant versus 21.4% for anastrozole).1 The most common AEs in the fulvestrant group following the primary analysis were bone pain (13.9%), nausea (10.9%), arthralgia (9.9%), constipation (9.9%), vomiting (8.9%), and dyspnea (8.9%).2

“Postmenopausal patients with advanced stages of hormone-receptor positive breast cancer continue to face an unmet need. An extension in overall survival of almost six months in the FIRST study represents a clinically meaningful benefit for this patient group,” said Professor John Robertson, lead investigator and Professor of Surgery at the University of Nottingham, UK.

These updated findings from the FIRST study provide evidence supporting the important role fulvestrant can potentially play in the future of treatment of postmenopausal women with advanced HR+ breast cancer. Previous data from the primary analysis of this study demonstrated that fulvestrant was as effective in terms of clinical benefit rate (CBR) as anastrozole2 while significantly delaying time to progression (TTP; 23.4 months vs. 13.1 months; HR 0.66; 95% CI 0.47, 0.92; p=0.010);3 no new safety concerns for fulvestrant were documented.

“These new findings are encouraging and we look forward to the results of the ongoing Phase III FALCON study, which is investigating the use of fulvestrant compared to anastrozole in hormone therapy naïve, advanced breast cancer patients,” said Antoine Yver, Head Oncology, Global Medicines Development at AstraZeneca. “Fulvestrant is just one example of how, for more than 40 years, we have been developing drugs that have significantly increased treatment options for cancer patients around the world. It is a legacy we are building on within our portfolio, which we believe has the potential to redefine the treatment paradigm for cancer.”

NOTES TO EDITORS

About Fulvestrant (FASLODEX 500mg)

The main goals of metastatic breast cancer treatment are to delay disease progression and extend survival.4 FASLODEX is approved for the treatment of postmenopausal women with estrogen receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.5 FASLODEX represents a hormonal therapy approach that targets the ER. FASLODEX blocks and degrades estrogen receptors, leading to downregulation. Consequently, ER signaling leading to tumor growth is disrupted.5,6,7,8

About the FIRST study1,3

The FIRST (Fulvestrant fIRst-line Study comparing endocrine Treatments) study is a Phase II, randomized, open-label study that compared the use of fulvestrant (delivered by intra- muscular injection on days 0,14, 28 and every 28 days thereafter) with anastrozole 1 mg (taken orally once daily). Patients had not received any prior endocrine therapy for advanced disease. The primary endpoint was clinical benefit rate (CBR), defined as the proportion of patients experiencing an objective response or stable disease for ≥ 24 weeks. Secondary endpoints included objective response rate (ORR), time to progression (TTP), duration of response, and duration of clinical benefit. The study included 205 patients from 62 centers across 9 countries.

The most common AEs in the fulvestrant group following the primary analysis were bone pain (13.9%), nausea (10.9%), arthralgia (9.9%), constipation (9.9%), vomiting (8.9%), and dyspnea (8.9%).8

Important Safety Information About FASLODEX® (fulvestrant) Injection

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 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

The full Prescribing Information for FASLODEX is available here.

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 cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. 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.

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1 Robertson JF, et al. Fulvestrant 500 mg versus anastrozole as first-line treatment for advanced breast cancer: overall survival from the Phase II ‘FIRST’ study. Presented at the San Antonio Breast Cancer Symposium (SABCS), San Antonio, Texas; 9-13 December 2014.
2 Robertson JF, et al. Activity of fulvestrant 500 mg versus anastrozole 1 mg as first-line treatment for advanced breast cancer: results from the FIRST study. J Clin Oncol. 2009 Sep 20;27(27):4530-5.
3 Robertson JF, et al. Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of advanced breast cancer: follow-up analysis from the randomized 'FIRST' study. Breast Cancer Res Treat. 2012 Nov;136(2):503-11
4 National Cancer Institute. Metastatic Cancer: Questions and Answers. Available online. Last accessed October 2014.
5 FASLODEX full Prescribing Information. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
6 Howell A. Is fulvestrant (“Faslodex”) just another selective estrogen receptor modulator? Int J Gynecol Cancer. 2006;16(2):521-523.
7 Carlson RW. The history and mechanism of action of fulvestrant. Clin Breast Cancer. 2005;6(suppl 1):S5-S8.
8 Wakeling AE. Similarities and distinctions in the mode of action of different classes of antioestrogens. Endocr Relat Cancer. 2000;7(1):17-28.

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