Kisqali-Faslodex Combo Prolongs Survival of Postmenopausal Women with Advanced Breast Cancer, Phase 3 Trial Shows

Kisqali-Faslodex Combo Prolongs Survival of Postmenopausal Women with Advanced Breast Cancer, Phase 3 Trial Shows
Kisqali (ribociclib) in combination with Faslodex (fulvestrant) prolongs the survival of postmenopausal women with HR-positive, HER2-negative, advanced or metastatic breast cancer, interim analysis of a Phase 3 clinical trial shows. The findings were presented in a late-breaking presentation titled, “Overall survival (OS) results of the phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) advanced breast cancer (ABC) treated with fulvestrant (FUL) + ribociclib (rib),” at the European Society for Medical Oncology (ESMO) 2019 Congress, held Sept. 27–Oct. 1, in Barcelona, Spain. Kisqali is a targeted therapy marketed by Novartis. It works by interfering with the activity of cyclin-dependent kinases (CDK) 4/6, which are enzymes that regulate cell proliferation and growth, and often are overactive in breast cancer. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of women with HR-positive, HER2-negative metastatic breast cancer. Faslodex is a type of hormone therapy marketed by AstraZeneca. It was first approved by the FDA in 2002 to treat postmenopausal women whose disease progressed after being treated with anti-estrogen therapy (e.g., tamoxifen) and later for other types of breast cancer. The effects of Kisqali in combination with Faslodex as a first- or second-line therapy are currently being assessed in the randomized, double-blind, placebo-controlled, MONALEESA-3 Phase 3 trial (NCT02422615). The trial enrolled 726 postmenopausal women with HR-positive, HER2-negative, advanced or metastatic breast cancer who were assigned randomly to either the Kisqali-Faslodex combo, or a placebo in combination with Faslodex. The trial’
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