MedicalResearch.com Interview with:
Gabriel N. Hortobagyi, MD, FACP
Professor of Medicine, Department of Breast Medical Oncology,
Division of Cancer Medicine, UTMDACC,
Nellie B. Connally Chair in Breast Cancer, Department of Breast Medical Oncology, Division of Cancer Medicine
Program Director, Department of Breast Medical Oncology
Susan G. Komen Interdisciplinary Breast Fellowship Program
The University of Texas MD Anderson Cancer Center
MedicalResearch.com: What is the background for this study?
Response: The MONALEESA-2 trial is a double-blind, randomized, Phase III trial that evaluated efficacy and safety of Kisqali plus letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who had not previously been treated for their advanced disease.
MedicalResearch.com: What are the main findings?
o Updated findings from the Phase III MONALEESA-2 trial confirm the efficacy and safety of Kisqali® (ribociclib) plus letrozole as a treatment option for HR+/HER2- advanced or metastatic breast cancer:
• After nearly one year of additional follow-up, Kisqali plus letrozole demonstrated median progression-free survival (PFS) of 25.3 months (95% CI: 23.0-30.3) compared to 16.0 months (95% CI: 13.4-18.2) for letrozole alone.
• The progression-free survival rate at two years was 54.7% in the Kisqali plus letrozole arm compared to 35.9% in patients treated with letrozole alone.
• In women with measurable disease, 55% of patients saw their tumor size shrink by at least 30% (overall response rate (ORR)) compared to 39% of patients with letrozole plus placebo.
• Treatment benefit remained consistent across all patient subgroups regardless of demographics or disease characteristics, including women with visceral disease and those diagnosed de novo.
o The safety profile of Kisqali plus letrozole remained consistent and the incidence of laboratory and electrocardiogram (ECG) irregularities were similar to that observed at the first interim analysis.
• The most common grade 3/4 laboratory abnormalities for Kisqali plus letrozole compared to letrozole alone were decreased neutrophils (62.6% vs 1.5%), decreased leukocytes (36.8% vs 1.5%), decreased lymphocytes (16.2% vs 3.9%) and elevated alanine aminotransferase (11.4% vs 1.2%).