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%).
MedicalResearch.com: What should readers take away from your report?
Response: This new look at the MONALEESA-2 data, after nearly an additional year of follow-up, demonstrates the continued efficacy of ribociclib plus letrozole. And, with more than two years of follow-up, the PFS data confirm the inclusion of ribociclib plus an aromatase inhibitor as a strong option among first-line treatments for HR-positive, HER2-negative advanced breast cancer.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
o I look forward to seeing safety and efficacy results of additional studies of Kisqali in multiple combinations across a broad range of patients and in the adjuvant setting.
• The MONALEESA clinical trial program includes two additional Phase III trials, MONALEESA-3 and MONALEESA-7, which are evaluating the efficacy and safety of Kisqali in combination with other endocrine therapies.
• A study is enrolling to further evaluate Kisqali in men and premenopausal women (CompLEEment-1). Additionally, Phase III trials evaluating Kisqali in the adjuvant therapy setting (EarLEE-1 and EarLEE-2) are initiating.
o There are currently no biomarkers to determine which patients with HR+ advanced breast cancer will respond best to Kisqali. Additional research to better understand predictors of response is ongoing.
MedicalResearch.com: Is there anything else you would like to add?
o Kisqali was approved by the U.S. Food and Drug Administration (FDA) on March 13, 2017, as a first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor.
o A marketing authorization application for ribociclib plus letrozole is under review by the European Medicines Agency (EMA).
o Disclosures include: receiving consulting fees from Eli Lilly and Pfizer.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Citation: ASCO 2017 abstract
Updated results from MONALEESA-2, a phase 3 trial of first-line ribociclib + letrozole in hormone receptor-positive (HR+), HER2-negative (HER2–), advanced breast cancer (ABC).
J Clin Oncol 35, 2017 (suppl; abstr 1038)
Author(s): Gabriel N. Hortobagyi, Salomon M. Stemmer, Howard A. Burris, Yoon Sim Yap, Gabe S. Sonke, Shani Paluch-Shimon, Mario Campone, Katarina Petrakova, Kimberly L. Blackwell, Eric P. Winer, Wolfgang Janni, Sunil Verma, Pier Franco Conte, Carlos L. Arteaga, David A. Cameron, Fengjuan Xuan, Michelle Kristine Miller, Caroline Germa, Samit Hirawat, Joyce O’Shaughnessy; The University of Texas MD Anderson Cancer Center, Houston, TX; Davidoff Cancer Center, Tel Aviv, Israel; Sarah Cannon Research Institute, Nashville, TN; National Cancer Centre Singapore, Singapore, Singapore; Netherlands Cancer Institute, Amsterdam, Netherlands; Sheba Medical Center, Tel HaShomer, Ramat Gan, Israel; Institut de Cancérologie de l’Ouest – René Gauducheau, Saint-Herblain, France; Masaryk Memorial Cancer Institute, Brno, Czech Republic; Duke University Medical Center, Durham, NC; Dana-Farber Cancer Institute, Boston, MA; University of Ulm, Ulm, Germany; Tom Baker Cancer Centre, Calgary, AB, Canada; University of Padova and Istituto Oncologico Veneto IRCCS, Padua, Italy; Vanderbilt University Ingram Cancer Center, Nashville, TN; Edinburg Cancer Research Centre, Edinburgh, United Kingdom; Novartis Pharmaceuticals Corporation, East Hanover, NJ; Baylor University Medical Center, Dallas, TX
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