medwireNews: Exploratory analyses from the MONALEESA-3 trial after more than 5 years of follow-up show that first-line use of ribociclib alongside fulvestrant continues to offers a significant overall survival (OS) benefit versus fulvestrant alone in patients with hormone receptor-positive, HER2-negative advanced breast cancer.
After a median of 70.8 months of follow-up, median OS was 15.8 months longer in treatment-naive patients given the CDK4/6 inhibitor plus fulvestrant than those given the endocrine therapy alone, with a significant hazard ratio (HR) of 0.67, and 5-year OS rates of 56.5% and 42.1%, respectively.
This finding represents “the longest median OS observed for a first-line population in a phase III trial setting in advanced breast cancer as of today,” presenting author Patrick Neven (University Hospitals Leuven, Belgium) told delegates at the ESMO Breast Cancer Congress 2022 in Berlin, Germany.
First-line ribociclib plus fulvestrant was also associated with significantly longer durations of time to second progression or death after discontinuing the study drugs and beginning next-line therapy (HR=0.64) and time to first use of chemotherapy or death after randomization (HR=0.62).
Noting that there were no new safety signals, Neven concluded that the “impressive results” add support for the first-line use of ribociclib in this advanced breast cancer population.
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