Premenopausal OS | 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 54 months

Nearly 5 years median overall survival for first-line premenopausal patients^1,2

1140_Lightboxed_Global_L09_M7_120_OS_Digital-01

Hazard ratios are based on stratified Cox model.

See OS in postmenopausal patients with an AI >

See OS in postmenopausal patients with fulvestrant >

At a median follow-up of 35 months

Superiority was established for overall survival in the first-line intent to treat (ITT) population
P=0.00973 (HR=0.71 [95% CI: 0.54-0.95])³

In the subgroup of patients who received tamoxifen, an increased risk for QT prolongation was observed. KISQALI is not indicated for concomitant use with tamoxifen⁴
mPFS (primary analysis): 23.8 months (95% CI: 19.2-NR) for KISQALI + ET vs 13.0 months for placebo + ET (95% CI: 11.0-16.4); HR=0.55 (95% CI: 0.44-0.69); P<0.0001⁴
Goserelin was used for ovarian suppression⁵

See Trial Design >

See OS & QoL Congress Data for KISQALI >

Yen-Shen Lu, MD
National Taiwan University Hospital
Taipei, Taiwan
Dr Lu provides an expert perspective on the updated ad hoc exploratory analysis for MONALEESA-7.

Michelino De Laurentiis, MD, PhD
National Cancer Institute
Naples, Italy
Hear Dr De Laurentiis discuss results from the updated ad hoc exploratory OS analysis.

AI, aromatase inhibitor; 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.

References: 1. Tripathy D, Im S-A, Colleoni M, et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/ HER2–) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Presented at: San Antonio Breast Cancer Symposium; December 8-12, 2020; San Antonio, TX. Poster PD2-04. 2. Data on file. Novartis Pharma AG. 3. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med. 2019;381(4):307-316. 4. KISQALI [Summary of Product Characteristics]. Novartis Pharma AG; 2019. 5. Tripathy D, Im S-A, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018;19(7):904-915.