21MO Primary results of a China bridging, phase II randomized study of initial endocrine therapy (ET) ± ribociclib (RIB) in pre- & postmenopausal Chinese women with HR+/HER2– ABC

Abstract

MONALEESA (ML)-2 and -7 enrolled postmenopausal (postM) and premenopausal (preM) patients (pts) with HR+/HER2− ABC, respectively, to initial RIB + ET treatment. Both demonstrated a statistically significant PFS and OS benefit in the ITT populations, with similar trends in the Asian subgroups. Specifically, regarding PFS in the Asian subgroups, RIB + ET had an HR of 0.39 (0.17-0.91) in ML-2 (n=51; median follow-up 15.3 mo) and ET had an HR of 0.40 (0.26-0.63) in ML-7 (n=198; median follow-up 19.2 mo).