Key clinical point: Ribociclib plus letrozole vs. letrozole alone prolonged overall survival (OS) by 12.5 months in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.
Major finding: After a median follow-up of 80 months, ribociclib+letrozole showed significant survival benefit over placebo+letrozole (median overall survival 63.9 vs. 51.4 months; hazard ratio for death 0.76; 2-sided P = .008). No new safety signals were identified.
Study details: Findings are from the phase 3 MONALEESA-2 trial including 668 postmenopausal women with HR+/HER2- recurrent or metastatic breast cancer who had not received prior systemic therapy for advanced disease and were randomly assigned to receive first-line ribociclib or placebo, both with letrozole.
Disclosures: This study was funded by Novartis. Five authors declared being employees or stockholders of Novartis and others reported ties with various sources, including Novartis.
Source: Hortobagyi GN et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med. 2022;386:942-950 (Mar 10). Doi: 10.1056/NEJMoa2114663