An exploratory analysis of 2 phase 3 trials evaluating ribociclib (Kisqali, Novartis) plus endocrine therapy in advanced breast cancer showed positive results.
Results from an exploratory analysis of 2 phase 3 trials demonstrated significant overall survival (OS) benefit of Novartis’ ribociclib (Kisqali) in hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer with visceral metastases.1
The findings, which resulted from a subgroup analysis of the phase 3 MONALEESA-3 and MONALEESA-7 trials, were presented during the ASCO20 Virtual Scientific Program.1
According to the analysis, the presence of visceral metastases in this patient population generally signifies poor prognosis, with a particularly poor survival in patients with CNS and liver metastases. Additionally, patients with CNS metastases are typically excluded from pivotal clinical trials, but were allowed to enroll in MONALEESA-3 if their metastatic lesions in the CNS were stable without steroids or enzyme-inducing antiepileptic medications, the study investigators noted.1
The MONALEESA trials evaluated ribociclib in premenopausal women in combination with nonsteroidal aromatase inhibitor (NSAI) plus goserlin (MONALEESA-7) and in postmenopausal women in combination with fulvestrant (MONALEESA-3). Approximately 60% of the study participants had visceral metastases, excluding visceral crises. Among these patients, treatment with ribociclib in combination with endocrine therapy demonstrated a 30% reduction in the risk of death in MONALEESA-7 (median OS of not evaluable [NE] versus 39 months with NSAI plus goserelin; HR=0.698 [95% CI: 0.462-1.054]) and a 20% reduction in the risk of death in MONALEESA-3 (median OS of 41.0 versus 39.4 months with fulvestrant; HR=0.804 [95% CI: 0.596-1.083)].1
Additionally, in patients with liver metastases, a group with especially poor prognosis, the findings showed that ribociclib combination therapy resulted in a 47% reduction in the risk of death in MONALEESA-7 (median OS of NE versus 33.6 months with NSAI plus goserelin; HR=0.629 [95% CI: 0.421-0.942]). No new safety signals were observed.1
Overall, the study investigators noted that the OS data in these patients are consistent with the benefit observed with ribociclib in the overall population.1
“The analysis, looking across 2 phase 3 trials, supports the use of Kisqali in the first-line setting regardless of menopausal status or metastatic location,” principal investigator Denise Yardley, MD, Sarah Cannon Research Institute, said in a statement.2 “Patients with visceral metastases generally face worse prognosis and a higher risk for treatment resistance, so the consistent overall survival results with Kisqali combination therapy for these patients is compelling.”
1. Yardley DA., Nusch A, Yap Y, et al. Overall survival in patients with advanced breast cancer with visceral metastases, including those with liver metastases treated with ribociclib plus endocrine therapy in MONALEESA-3 and -7 trials. Presented at: 2020 ASCO Virtual Scientific Program; May 29-31, 2020; online.
2. Novartis Kisqali® shows overall survival benefit in HR+/HER2- advanced breast cancer with consistent findings in patients with more aggressive disease. News Release. Novartis; May 27, 2020. Accessed June 10, 2020. https://www.novartis.com/news/media-releases/novartis-kisqali-shows-overall-survival-benefit-hrher2-advanced-breast-cancer-consistent-findings-patients-more-aggressive-disease