Strong data for AstraZeneca's Faslodex

Anglo-Swedish drug major AstraZeneca says that the first results from the EFECT trial, presented at the annual San Antonio Breast Cancer Symposium, Texas, USA, confirm that Faslodex (fulvestrant) is a valuable treatment option for women with hormone-receptor positive advanced breast cancer. It is the first clinical trial to explore the use of the estrogen receptor antagonist, which is the first of a new type of endocrine therapy, in postmenopausal women who have progressed or recurred after treatment with non-steroidal aromatase inhibitor therapy.

At the time of analysis, 288 patients (82.1%) on Faslodex had progressed compared with 299 (87.4%) receiving Pfizer's Aromasin (exemestane) with a median time-to-progression of 3.7 months in both groups (p=0.6531).

Despite a majority of evaluable patients (67%) having visceral metastases - recognized by clinicians as a difficult-to-treat population - the clinical benefit rate, which includes both responding patients and those in whom the disease remains stable for at least six months, reached over 30% (Faslodex 32.2% vs exemestane 31.5%), making EFECT the first randomized Phase III trial to demonstrate that endocrine options show favorable clinical activity post NSAI, even in a certain proportion of patients with visceral involvement.