Dennis J. Slamon, MD, Director of Clinical/Translational Research, University of California, Los Angeles Jonsson Comprehensive Cancer Center. In this video, he speaks about the New Novartis data demonstrate only Kisqali® offers more life in the first-line setting for postmenopausal HR+/HER2- advanced breast cancer patients.
Novartis today announced updated median overall survival (OS) results for Kisqali® (ribociclib) in combination with fulvestrant in the first-line subgroup of postmenopausal women with advanced or metastatic breast cancer that is hormone receptor-positive but not human epidermal growth factor receptor-2 negative (HR+/HER2-). The examination of patients treated in first-line with Kisqali + fulvestrant revealed an approximately 16-month OS benefit when compared to those treated with fulvestrant alone. This updated exploratory OS analysis from the Phase III MONALEESA-3 project will be given as a late-breaker mini-oral session at the ESMO Breast Cancer Congress in 2022 (Abstract #LBA4).
Patients in this MONALEESA-3 exploratory investigation were assessed for a median of 71 months, more than two and a half years after the final major secondary endpoint OS analysis, which was reported at the ESMO Congress 2019 and published in the New England Journal of Medicine. The final OS analysis revealed a statistically significant OS benefit for Kisqali in combination with fulvestrant, as well as a 28% reduction in the risk of death compared to fulvestrant alone in the entire population (HR=0.72; 95 percent CI: 0.568-0.924; p=0.00455).
Kisqali plus fulvestrant (n=237) obtained 67.6 months median OS compared to 51.8 months for those treated with fulvestrant alone (n=128) in the first-line context, according to this new updated data with a median follow-up of five years. (HR=0.673; 95% confidence interval: 0.504-0.899) 1. Patients treated with Kisqali with fulvestrant in the first-line context reported an additional one-and-a-half years of delay to subsequent chemotherapy treatment (49.2 months versus 29.0 months, respectively; HR=0.624; 95 percent CI: 0.481-0.810).
With this extended follow-up, the estimated five-year survival rate for women who got Kisqali in conjunction with fulvestrant in first-line was 56.5 percent (95 percent CI: 49.5-62.9), compared to 42.1 percent (95 percent CI: 33.2-50.7) for women who received fulvestrant alone1. Furthermore, at this lengthier follow-up, 16.5 percent of patients in the Kisqali plus fulvestrant arm (n=39) and 8.6 percent of those in the fulvestrant only arm (n=11) were still on therapy1. There were no new adverse events observed.