Newly published data from the MONALEESA-3 trial demonstrate that ribociclib is effective in patients with HR+/ HER2– breast cancer. In this trial, 726 postmenopausal women with disease relapse >12 months after completion of endocrine therapy were randomized in a 2:1 ratio to receive fulvestrant plus ribociclib or fulvestrant alone. Patients in the ribociclib plus fulvestrant group had a median progression-free survival (PFS) duration of 20.5 months versus 12.8 months (hazard ratio 0.59, 95% CI 0.48–0.73; P < 0.001). Improvements in PFS in the ribociclib group were accompanied by increased risks of several grade 3 adverse events including neutropenia (46.6% versus 0%) and leukopenia (13.5% versus 0%), in addition to grade 4 neutropenia (6.8% versus 0%). These findings demonstrate the superiority of the addition of ribociclib to fulvestrant monotherapy in this setting.
Slamon, D. J. et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J. Clin. Oncol. https://doi.org/10.1200/JCO.2018.78.9909 (2018)
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Sidaway, P. Ribociclib effective in HR+, HER2– breast cancer. Nat Rev Clin Oncol 15, 532 (2018). https://doi.org/10.1038/s41571-018-0059-2