On June 1, 2019, it was announced that the international, randomized phase III MONALEESA-7 clinical trial has found that adding the Novartis drug ribociclib (Kisqali®) to standard-of-care endocrine therapy significantly improved overall survival for pre-menopausal women with advanced hormone receptor (HR)-positive/HER2-negative breast cancer compared with endocrine therapy alone. After 42 months of follow-up, the survival rate was 70% for women who took the combination therapy compared with 46% for women who received endocrine therapy only. Advanced breast cancer is the leading cause of cancer death in women 20 to 59 years of age. The MONALEESA-7 study results were presented on June 1, 2019 at the American Society of Clinical Oncology (ASCO) Annual Meeting (https://meetings.asco.org/am/learn-engage )in Chicago, Illinois, and were featured in a June 1 ASCO press briefing. The ASCO abstract (LBA 1008) is titled “Phase III MONALEESA-7 trial of Premenopausal Patients with HR+/HER2- Advanced Breast Cancer (ABC) Treated with Endocrine Therapy ± Ribociclib: Overall Survival (OS) Results.” “This is the first study to show improved survival for any targeted therapy when used with endocrine therapy as a first-line treatment for advanced breast cancer,” said the study’s lead author Sara A. Hurvitz (photo), MD, Director of the Breast Cancer Clinical Research Program at the UCLA Jonsson Comprehensive Cancer Center in Los Angeles, CA. “The use of ribociclib as a front-line therapy significantly prolonged overall survival, which is good news for women with this terrible disease. Overall survival benefit is considered the 'gold standard' in cancer trials, but is challenging to achieve in HR+/HER2- metastatic breast cancer. MONALEESA-7 reached this important endpoint earlier than anticipated.
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