On October 8, 2016 AstraZeneca reported data from the Phase III FALCON trial demonstrating superior median progression-free survival (PFS) for Faslodex (fulvestrant) 500mg compared to Arimidex (anastrozole) 1mg in the 1st line treatment of postmenopausal women with locally-advanced or metastatic breast cancer (Press release, AstraZeneca, OCT 8, 2016, View Source [SID:SID1234515667]). The primary endpoint was PFS, and the FALCON trial enrolled 462 patients.1

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The results, announced at the 2016 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, show that 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 a 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 (AEs) in the fulvestrant and anastrozole arms were arthralgia (16.7% vs. 10.3%), hot flush (11.4% vs. 10.3%), and nausea (10.5% vs. 10.3%), respectively.

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."

About FALCON

The FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy Naïve advanced breast cancer) trial is a Phase III, randomised, double-blind, multicentre trial. It compared the antitumour effects and tolerability profile of a 500mg dose of fulvestrant plus placebo with a 1mg dose of anastrozole plus placebo, in postmenopausal women with HR+, locally-advanced or metastatic breast cancer who had not been treated previously with any hormonal therapy.

The FALCON trial was designed on the basis of positive results from the Phase II FIRST trial, which demonstrated a median overall survival nearly six months longer with fulvestrant compared to anastrozole.4

About Advanced Breast Cancer

Advanced/metastatic breast cancer refers to Stages III and IV breast cancer. Stage III disease may be referred to as locally-advanced breast cancer. Metastatic breast cancer is the most advanced stage of breast cancer (Stage IV), and occurs when cancer cells have spread beyond the initial tumour site to other parts of the body outside the breast. Since there is no cure for the disease, the goal of current treatment is to delay disease progression.5

About Fulvestrant

Fulvestrant is indicated for the treatment of postmenopausal women with oestrogen receptor-positive (ER+), locally-advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen.2

In the US, fulvestrant is also approved, in combination with palbociclib, for the treatment of women with HR+, HER2- advanced or metastatic breast cancer, whose cancer has progressed after endocrine therapy.3 Fulvestrant represents a hormonal therapy approach that helps to slow tumour growth by blocking and degrading the oestrogen receptor – a key driver of disease progression.3,6