Verzenio-Faslodex Combo Prolongs Survival in Advanced Breast Cancer, Interim Phase 3 Data Show

Verzenio-Faslodex Combo Prolongs Survival in Advanced Breast Cancer, Interim Phase 3 Data Show
Verzenio (abemaciclib) in combination with Faslodex (fulvestrant) prolongs the survival of women with HR-positive, HER2-negative advanced or metastatic breast cancer who had been previously treated with endocrine therapy, interim analysis of a Phase 3 trial shows. Verzenio is a cancer medication marketed by Eli Lilly. It is a strong inhibitor of cyclin-dependent kinases (CDK)4/6, which are enzymes that regulate cell proliferation and growth, and are often overactive in breast cancer. In 2017, Verzenio was approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain types of advanced or metastatic breast cancers. Faslodex is a form of hormone therapy marketed by AstraZeneca. It was approved by the FDA in 2002 for the treatment of 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 Verzenio in combination with Faslodex are currently being assessed in the randomized, double-blind, placebo-controlled MONARCH 2 Phase 3 trial (NCT02107703). The trial enrolled 669 pre-, peri-, and postmenopausal women with HR-positive, HER2-negative metastatic breast cancer whose disease progressed following endocrine therapy. All patients were randomly assigned to receive either the Verzenio-Faslodex combo, or a placebo in combination with Faslodex. Treatment lasted until disease progression or unacceptable toxicity. The trial's primary endpoint was to determine patients' progression-free survival (the time patients live without their disease worsening). Secondary endpoints included assessing patients' overall survival, objective response, and duration of response to treatment. Previous findings from MONARCH 2 demonstrated the stu
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