AstraZeneca has revealed positive data from its FALCON Phase 3 clinical trial for metastatic breast cancer.
More specicically, the trial evaluated Faslodex (fulvestrant) versus Arimidex (anastrozole) as a treatment option for metastatic or locally-advanced breast cancer, in post-menopausal women who had not been previously treated with hormonal treatment for hormone-receptor-positive (HR+) breast cancer.
Compared to Arimidex, Faslodex showed clinical superiority.
The Phase 3 FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy Naïve advanced breast cancer) trial met the study’s primary goal of prolonged progression-free survival. Results from the clinical study demonstrated adverse side effects expected, and consistent with knowlege that already existed about the drugs.
According to a press release, Sean Bohen, executive vice president of 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. Faslodex has over 10 years of clinical evidence and we are committed to exploring its potential along with the rest of our outstanding oncology portfolio.”
Aromatase inhibitors like Arimidex are currently the first-line gold standard of care for postmenopausal women with a diagnosis of advanced HR+ breast cancer – which usually refers to metastatic breast cancer, or Stage 4 breast cancer, because the cancer has spread to other organs of the body.
Stage 3 breast cancer refers to locally advanced breast cancer that is spread only in the area of the breast, but not to distant organs and tissues.
Faslodex is a drug agent approved as treatment for postmenopausal women who have a diagnosis of oestrogen-receptor (ER)-positive locally-advanced or metastatic breast cancer whose cancer has progressed following anti-oestrogen therapy.
In March, the US Food and Drug Administration (FDA) approved Faslodex combined with palbociclib, as a treatment option for patients with hormone-receptor-positive, human-epidermal-growth-factor-receptor 2-negative (HER2-) advanced or metastatic breast cancer, whose disease has progressed following endocrine therapy.
A comprehensive analysis of FALCON is ongoing. AstraZeneca expects to present the results later this year.