The MONALEESA (Mammary Oncology Assessment of LEE011’s 55Efficacy and Safety) clinical trial program includes the MONALEESA-2, MONALEESA-3, and MONALEESA-7 trials. These trials are investigating the clinical activity and safety of ribociclib across a diverse population of patients. The initial US FDA approval of ribociclib was based on the results of the Phase III MONALEESA-2 trial, which evaluated the combination of ribociclib with letrozole as first-line therapy in postmenopausal women with advanced breast cancer.
The latest Clinical Trial Evaluation published in Future Oncology reviews the rationale, design and available results from the MONALEESA clinical program.
Ribociclib has received approval in the pre/peri- and postmenopausal disease settings on the basis of the MONALEESA trials. MONALEESA-2 demonstrated that ribociclib plus letrozole significantly improved progression-free survival (PFS) compared with placebo plus letrozole as first-line therapy in postmenopausal patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer (ABC). Subsequently, ongoing trials reported significant PFS improvements with ribociclib in combination with either fulvestrant in postmenopausal patients with ABC who were either treatment naive or received ≤1 line of prior endocrine therapy in the advanced disease setting (MONALEESA-3) or tamoxifen/nonsteroidal aromatase inhibitor with ovarian function suppression in pre/perimenopausal women (MONALEESA-7). This review summarizes the MONALEESA clinical program.
ClinicalTrials.gov identifiers: NCT01958021 (MONALEESA-2), NCT02422615 (MONALEESA-3), NCT02278120 (MONALEESA-7).