39OPooled analysis of efficacy and safety in Asian patients (pts) in the MONALEESA-2, MONALEESA-3, and MONALEESA-7 trials of ribociclib (RIB) plus endocrine therapy (ET)

Abstract Background We performed a pooled analysis of Asian pts in the phase III MONALEESA (ML) trials, which tested ET ± RIB in pts with hormone receptor–positive/human epidermal growth factor receptor-2–negative advanced breast cancer. Methods ML-2 and ML-3 enrolled postmenopausal pts; ML-7 enrolled pre/perimenopausal pts. To pool a homogenous population and reflect health authority recommended treatment, this analysis included all pts from ML-2, first-line pts from ML-3 and pts treated with a nonsteroidal aromatase inhibitor from ML-7. Results Pts were assigned to ET + PBO (118 Asian; 562 non-Asian) or ET + RIB (136 Asian; 651 non-Asian). In Asian pts, median PFS was 12.7 mo (95% CI, 9.1-15.6) with PBO vs not reached (NR; 95% CI, 16.6-NR) with RIB (hazard ratio [HR], 0.49 [95% CI, 0.34-0.70]). In non-Asian pts, median PFS was 16.5 mo (95% CI, 14.5-18.2) with PBO vs 25.3 mo (95% CI, 23.8-27.7) with RIB (HR, 0.59 [95% CI, 0.50-0.69]). In 182 Asian pts with visceral mets, median PFS was 12.7 mo (95% CI, 8.8-16.0) with PBO vs 23.9 mo (95% CI, 14.8-NR) with RIB (HR, 0.54 [95% CI, 0.36-0.82]). In 687 non-Asian pts with visceral mets, median PFS was 13.0 mo (95% CI, 11.1-14.9) with PBO vs 23.9 mo (95% CI, 19.9-29.6) with RIB (HR, 0.55; 95% CI, 0.44-0.68). In Asian pts, overall response rate (ORR) was 33.1% (95% CI, 24.6-41.5) with PBO vs 49.3% (95% CI, 40.9-57.7) with RIB (P = 0.005). In non-Asian pts, ORR was 27.8% (95% CI, 24.1-31.5) with PBO vs 38.2% (95% CI, 34.5-42.0) with RIB (P  Conclusions Significant improvements in PFS and ORR were observed in Asian pts with RIB vs PBO. Discontinuation rates due to AEs were lower in Asian pts. Clinical trial identification NCT01958021; NCT02422615; NCT02278120. Legal entity responsible for the study Novartis Pharmaceutical Corporation. Funding Novartis Pharmaceutical Corporation. Disclosure S-A. Im: Research grant / Funding (self): AstraZeneca; Advisory / Consultancy: Novartis; Advisory / Consultancy: Hanmi; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Eisai. Y-S. Yap: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Novartis; Advisory / Consultancy: Pfizer; Travel / Accommodation / Expenses: Eisai; Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy: Roche. K.S. Lee: Advisory / Consultancy: Lily; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Roche; Research grant / Funding (self): Dong-A Socio. L.M. Tseng: Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Research grant / Funding (self), Travel / Accommodation / Expenses: Roche Pharma AG; Research grant / Funding (self): MSD; Travel / Accommodation / Expenses: GlaxoSmithKline. S.C. Lee: Honoraria (self): ACT Genomics; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Eisai; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Pfizer; Research grant / Funding (self): Taiho Pharmaceutical; Travel / Accommodation / Expenses: Amgen. Y.H. Park: Honoraria (self), Travel / Accommodation / Expenses: Merck; Honoraria (self), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy: Pfizer; Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): Eisai. I. Gounaris: Non-remunerated activity/ies: PharmaMar; Shareholder / Stockholder / Stock options, Full / Part-time employment: Novartis. M. Sondhi: Shareholder / Stockholder / Stock options, Full / Part-time employment: Novartis. A. Ridolfi: Shareholder / Stockholder / Stock options, Full / Part-time employment: Novartis. J.P. Zarate: Shareholder / Stockholder / Stock options, Full / Part-time employment: Novartis. Y-S. Lu: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Clinical trial study fee; Grant for clinical study for ESR1 mutation detected by cell free DNA;: Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Pfizer; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Research grant / Funding (self): Roche; Research grant / Funding (self): Merck Sharp & Dohme; Research grant / Funding (self): GlaxoSmithKline. All other authors have declared no conflicts of interest.