Phase III MONALEESA-7 trial of premenopausal patients with HR+/HER2− advanced breast cancer (ABC) treated with endocrine therapy ± ribociclib: Overall survival (OS) results.

• DOI: 10.1200/jco.2019.37.18_suppl.lba1008
• Publication Date: 2019-06-05T19:00:57Z
• Authors: Sara A. Hurvitz; Seock-Ah Im; Yen-Shen Lu; Marco Colleoni; Fabio Andre Franke; Aditya Bardia; Nadia Harbeck; Louis Chow; Joohyuk Sohn; Keun Seok Lee; Saul Campos Gomez; Rafael Villanueva; Kyung Hae Jung; Arunava Chakravartty; Gareth Hughes; Ioannis Gounaris; Karen Rodriguez-L...; Tetiana Taran; Debu Tripathy
• Keywords: Letrozole; Goserelin; Anastrozole; Clinical endpoint

LBA1008 Background: The phase III MONALEESA-7 study (NCT02278120) is the first dedicated trial of endocrine therapy (ET) ± a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor in premenopausal patients (pts) with hormone receptor–positive (HR+)/HER2− ABC. met its primary endpoint significantly longer progression-free survival (PFS) ribociclib (RIB; CDK4/6 inhibitor) + ET vs placebo (PBO) (median, 23.8 13.0 mo; HR, 0.55; P < 0.0001; Tripathy D, et al. Lancet Oncol. 2018). Methods: Premenopausal pts (N=672) HR+/HER2− ABC were treated RIB or PBO goserelin and either nonsteroidal aromatase (NSAI; letrozole anastrozole) tamoxifen. This 2nd 3 protocol-specified OS analyses (scheduled to occur after ≈ 189 deaths [75% planned total events]). was evaluated by Kaplan-Meier methods, statistical comparison made 1-sided stratified log-rank test, protocol-defined Lan-DeMets (O’Brien-Fleming) stopping boundary p 0.01018 for superior efficacy. Results: data cutoff this prespecified interim analysis Nov 30, 2018, median follow-up 34.6 mo (min, 28.0 mo). At cutoff, 173 continuing treatment (RIB, n=116; PBO, n=57), 192 n=83; n=109). demonstrated than not reached 40.9 [95% CI, 37.80 mo-not evaluable]; 0.712 0.54-0.95]; = 0.00973). result crossed Estimated rates at 42 70.2% 46.0%, respectively. In who received an NSAI (n=495), consistent improvement (HR, 0.699 0.50-0.98]). Posttreatment use balanced between arms 68.9%; 73.2%). Conclusions: clinically statistically significant alone time that any targeted agent has as initial endocrine-based therapy. Clinical information: NCT02278120.