Updated OS results with ribociclib or placebo added to endocrine therapy for HR+/HER2- ABC in pre-or perimenopausal patients

The multinational phase 3 MONALEESA-7 study randomized pre- and perimenopausal women with HR-positive/HER2-negative advanced breast cancer to ribociclib plus endocrine therapy or placebo plus endocrine therapy. In the protocol-specified final analysis the median overall survival was not met in the ribociclib arm. Exploratory analysis with extende follow-up (median, 53,5 months) found found significantly longer OS with ribociclib than with placebo (58.7 versus 48.0 months; HR 0.76; 95% CI 0.61-0.96), including in patients younger than 40 years.