47MO - Efficacy and quality of life (QOL) in premenopausal Asian patients (pts) with hormone receptor–positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC) treated in the MONALEESA (ML)-7 study

Background

In the phase III ML-7 trial, ribociclib (RIB) + endocrine therapy (ET) prolonged progression-free survival (PFS) and overall survival (OS) vs placebo (PBO) + ET in premenopausal pts with HR+, HER2− ABC. The RIB benefit was observed irrespective of ET partner (nonsteroidal aromatase inhibitor [NSAI] or tamoxifen [TAM]). Here we report outcomes in Asian pts enrolled in the ML-7 trial receiving an NSAI + RIB or PBO.

Methods

Pre/perimenopausal pts (≤ 1 line of prior chemotherapy; no prior ET for ABC) who received RIB or PBO + NSAI (letrozole or anastrozole) were included in this analysis. The primary end point was PFS, with a prespecified subset analysis in Asian pts. OS, overall response rate (ORR), clinical benefit rate (CBR), QOL, and safety were secondary end points.

Results

166 pts (34% of the total NSAI cohort) were included (RIB, n=82; PBO, n=84); 31% of pts had de novo metastatic disease, and 4% and 66% had a DFI ≤ 12 mo and > 12 mo, respectively. As of 30 Nov 2018, 33 and 16 pts in the RIB and PBO arms, respectively, were still receiving treatment; the primary cause of discontinuation was disease progression (50% for RIB vs 70% for PBO). A consistent PFS and OS benefit with RIB vs PBO was observed in Asian pts vs the intention-to-treat population (Table). ORR and CBR favored RIB + NSAI vs PBO + NSAI in Asian pts with measurable disease at baseline. The EORTC QLQ-C30 global health score was generally maintained throughout RIB treatment. The only grade 3/4 adverse event occurring in > 20% of pts in either arm was neutropenia (78% for RIB vs 4% for PBO).

Conclusions

These findings indicate that treatment with RIB + NSAI improved PFS nearly 3-fold and prolonged OS with a relative reduction in risk of death of 56% vs PBO + NSAI in Asian pts with HR+/HER2− ABC. Safety findings in Asian pts were consistent with the overall population, and QOL was maintained during RIB + NSAI treatment. Table: 47MO

^a ORR = CR+PR in pts with measurable disease (RIB, n = 65; PBO, n = 76) ^b CBR = CR+PR or SD or non-CR/non-PD ≥ 24 weeks in pts with measurable disease.

Clinical trial identification

NCT02278120.

Editorial acknowledgement

Medical editorial assistance was provided by Casey Nielsen of MediTech Media, Ltd.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

Y-S. Lu: Research grant/Funding (self), Clinical trial study fee: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Research grant/Funding (institution), Grant for clinical study for ESR1 mutation detected by cell free DNA; Advisory board consultation fee; Speaker fee: Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Consultation fee; Contracted research: Pfizer; Honoraria (self), Advisory/Consultancy, Consultation fee: Boehringer Ingelheim; Research grant/Funding (institution), Contracted research: Roche; Research grant/Funding (institution), Contracted research: Merck Sharp & Dohme; Honoraria (self), Speaker Bureau/Expert testimony, Speaker Fee: Eisai. J. Sohn: Research grant/Funding (institution): MSD; Roche; Novartis; AstraZeneca; Lilly; Pfizer; Bayer; GlaxoSmithKline; Contessa; Daiichi Sankyo. K.S. Lee: Honoraria (self), Advisory/Consultancy, Consulting or advisory role: Eli Lilly; Novartis; Pfizer; Roche; Research grant/Funding (institution), Research Funding: Dong-A Socio. K.H. Jung: Honoraria (self): Novartis. M-C. Liu: Honoraria (self), Advisory/Consultancy, Advisory Board: Pfizer; Honoraria (self), Advisory/Consultancy, Advisory Board: Roche; Honoraria (self), Advisory/Consultancy, Advisory Board: Novartis; Travel/Accommodation/Expenses, Travel Fee: Itnl Congress on Clinical Trials Hemo-Oncology. Y.S. Yap: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Honoraria, consultancy, research support: Novartis; Honoraria (self), Advisory/Consultancy, Consulting or advisory role: Pfizer; Travel/Accommodation/Expenses: Eisai; Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Consulting or advisory role: Roche. A. Gaur: Full/Part-time employment: Novartis. Y. Wang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis. M. Gao: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis. S-A. Im: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Research grant, advisory board role: AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, Advisory Board Role, travel support: Novartis; Honoraria (self), Advisory/Consultancy, Advisory Board role: Hanmi; Honoraria (self), Advisory/Consultancy, Advisory Board role: Pfizer; Honoraria (self), Advisory/Consultancy, Participation in advisory meetings: Eisai; Honoraria (self), Advisory/Consultancy, Participation in advisory meetings: Amgen; Honoraria (self), Advisory/Consultancy, Participation in advisory meetings: MediPacto; Honoraria (self), Advisory/Consultancy, Participation in advisory meetings: Roche; Honoraria (self), Advisory/Consultancy, Participation in advisory meetings: Lilly. All other authors have declared no conflicts of interest.