Postmenopausal OS with fulvestrant | KISQALI® (ribociclib) Professional Site

For Healthcare Professionals Outside the US
KISQALI is indicated for the treatment of women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)—negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist.

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Long-term follow-up: Ad hoc exploratory analysis with a median follow-up of 71 months

Over 5.5 years median overall survival for first-line postmenopausal patients with fulvestrant^1,2

1140_Lightboxed_L02_M3_GLOBAL_OS_125_DKT_MOB_M3_1L_OS_desktop.png

Hazard ratios are based on stratified Cox model.

See OS in premenopausal patients with ET >

See OS in postmenopausal patients with an AI >

At a median follow-up of 39 months

Statistically significant improvement in overall survival in the ITT population:

mOS with KISQALI + fulvestrant not reached (95% CI: 42.5-NR) vs 40.0 months with placebo + fulvestrant (95% CI: 37.0-NR); P=0.00455 (HR=0.72 [95% CI: 0.57-0.92])³
mPFS was 20.5 months (95% CI: 18.5-23.5) with KISQALI + fulvestrant vs 12.8 months (95% CI: 10.9-16.3) with placebo + fulvestrant (HR=0.593 [95% CI: 0.480-0.732]; P<0.001)^4,5

The first-line patient group comprised late-relapse (patients whose disease relapsed >12 months after completion of [neo]adjuvant ET with no subsequent treatment) and de novo (those with de novo disease and no prior ET) patients.¹

See trial design >

See OS in liver metastases >

See OS in ET resistance >

Dennis Slamon, MD, PhD
University of California, Los Angeles
Los Angeles, CA
Dr Dennis Slamon summarizes the importance of the MONALEESA-3 results for first-line
patients and quality of life

Stephen Chia, MD, FRCPC
British Columbia Cancer Center
Vancouver, Canada
Watch Dr Stephen Chia discuss the significance of the overall survival results from MONALEESA-3 in a historically challenging-to-treat patient population

Patrick Neven, MD
University Hospitals Leuven, Campus Gasthuisberg
Leuven, Belgium
Watch Dr Patrick Neven describe the robust and clinically significant impact of the MONALEESA-3 results

Stephen Chia, MD
British Columbia Cancer Agency, Vancouver
Vancouver, Canada
See Dr Stephen Chia discuss how the updated MONALEESA-3 results bring optimism for first-line patients and clinicians

Peter Fasching, MD
Universitätsklinikum Erlangen
Erlangen, Germany
Dr Peter Fasching explains the significance
of the treatment benefit of combination
therapy in MONALEESA-3 for first-line patients

Michelino De Laurentiis, MD
National Cancer Institute
Naples, Italy
Dr Michelino De Laurentiis describes how MONALEESA-3 is unique in the landscape of CDK4/6 inhibitor trials and describes the unprecedented efficacy of the 71-month follow-up

AI, aromatase inhibitor; CDK, cyclin-dependent kinase; CI, confidence interval; ET, endocrine therapy; HR, hazard ratio; ITT, intent to treat; mOS, median overall survival; mPFS, median progression-free survival; NR, not reached; OS, overall survival.

References: 1. Slamon DJ, Neven P, Chia S, et al. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol. 2021;32(8):1015-1024. doi:10.1016/j.annonc.2021.05.353 2. Data on file. Novartis Pharma AG. 3. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382(6):514-524. doi:10.1056/NEJMoa1911149 4. KISQALI [Summary of Product Characteristics]. Novartis Pharma AG; 2019. 5. Slamon DJ, Neven P, Chia S, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: MONALEESA-3. J Clin Oncol. 2018;36(24):2465-2472. doi:10.1200/JCO.2018.78.9909