3596 - Updated overall survival (OS) and quality of life (QoL) in premenopausal patients (pts) with advanced breast cancer (ABC) who received ribociclib (RIB) or placebo (PBO) plus goserelin and a nonsteroidal aromatase inhibitor (NSAI) in the MONALEESA-7 (ML-7) trial

Background

RIB plus an NSAI is indicated for premenopausal pts with hormone-receptor–positive (HR+), HER2− ABC based on data from the ML-7 trial (NCT02278120), including progression-free survival (PFS), which was longer with RIB vs PBO (median 23.8 vs 13.0 months; HR 0.55; P < 0.0001). It is important to understand how PFS data translate to pt benefit in terms of OS and QoL. Maintenance of functioning, work productivity and activity, and pain reduction have been reported for the overall population. We present updated OS and QoL data (cutoff: 30 November 2018) for pts who received an NSAI.

Methods

Pre/perimenopausal pts with HR+/HER2− ABC, ≤ 1 line of prior chemotherapy, and no prior endocrine therapy for ABC were randomized 1:1 to receive RIB or PBO plus goserelin with either an NSAI (letrozole or anastrozole) or tamoxifen. The primary endpoint was PFS. OS, the key secondary endpoint, was evaluated by stratified log-rank test in the overall population and summarized using Kaplan-Meier methods. Time to 10% deterioration (TTD) was estimated using the EORTC QLQ-C30 patient questionnaire and a stratified log-rank test.

Results

The NSAI cohort included 248 pts in the RIB arm and 247 in the PBO arm. As of the data cutoff, 37.1% of patients in the RIB arm and 18.6% of pts in the PBO arm remained on treatment. Of the pts who discontinued study treatment, 69.2% in the RIB arm and 73.1% in the PBO arm started subsequent therapy. Median OS was not reached in the RIB arm vs 40.7 months in the PBO arm (hazard ratio, 0.699 [95% CI, 0.501-0.976]), and the benefit of adding RIB was generally consistent across pt subgroups within this cohort. Median TTD in global QoL was 34.2 months in the RIB arm vs 23.3 months in the PBO arm (hazard ratio, 0.69 [95% CI, 0.52-0.91]). Analyses of key QoL domains will be presented at the meeting. Updated analyses of adverse events revealed no unexpected safety signals.

Conclusions

RIB plus an NSAI prolonged OS and improved QoL vs PBO plus an NSAI in premenopausal pts with HR+, HER2– ABC. Additional follow-up did not reveal any new safety signals in this subgroup.

Clinical trial identification

NCT02278120.

Editorial acknowledgement

John McGuire, PhD, of MediTech Media, LLC funded by Novartis Pharmaceuticals Corporation.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

Y. Lu: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Clinical trial study fee, grant, advisory board, speaker: Novartis; Advisory / Consultancy, Consultation fee: Pfizer; Advisory / Consultancy: Boehringer Ingelheim; Research grant / Funding (self): Roche; Research grant / Funding (self): Merck Sharp & Dohme; Research grant / Funding (self): Pfizer; Research grant / Funding (self): GlaxoSmithKline. A. Bardia: Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Genentech; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck; Research grant / Funding (institution): Sanofi; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Radius Health; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Immunomedics; Research grant / Funding (institution): Mersana; Research grant / Funding (institution): Innocrin; Advisory / Consultancy: Biothernostics Inc.; Advisory / Consultancy, Travel / Accommodation / Expenses: Spectrum Pharma; Advisory / Consultancy, Travel / Accommodation / Expenses: Taiho; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy: Daiichi Pharma. R.V. Vázquez: Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Roche. M.A. Colleoni: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Pfizer; Honoraria (self): Novartis; Advisory / Consultancy: OBI Pharma; Advisory / Consultancy: Puma Biotechnology; Advisory / Consultancy: Celldex. D. Tripathy: Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Pfizer. B.R. Lanoue: Shareholder / Stockholder / Stock options, Full / Part-time employment: Novartis. D. Chandiwana: Shareholder / Stockholder / Stock options, Full / Part-time employment: Novartis. A. Ridolfi: Shareholder / Stockholder / Stock options, Full / Part-time employment: Novartis. G. Hughes: Shareholder / Stockholder / Stock options, Full / Part-time employment: Novartis. J.P. Zarate: Shareholder / Stockholder / Stock options, Full / Part-time employment: Novartis. I. Gounaris: Non-remunerated activity/ies: PharmaMar; Shareholder / Stockholder / Stock options, Full / Part-time employment: Novartis. N. Harbeck: Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer. All other authors have declared no conflicts of interest.