Postmenopausal OS with AI | 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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At a median follow-up of 80 months

Over 5 years median overall survival for first-line postmenopausal patients with an AI¹

Overall survival improved with a 24% reduction in risk of death¹

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See OS in premenopausal patients with ET >

See OS in postmenopausal patients with fulvestrant >

KISQALI is the only CDK4/6 inhibitor with statistically significant overall survival proven in postmenopausal patients with an AI^1-3

MONALEESA-2: N=668, 1:1 randomization. As 1L in advanced disease. KISQALI 600 mg or placebo once daily (3 weeks on/1 week off) + letrozole 2.5 mg. Statistical significance was established in the first interim analysis (HR=0.56 [95% CI: 0.43-0.72]; P<0.0001). In an updated analysis, mPFS (primary end point) was 25.3 months for KISQALI + letrozole vs 16.0 months for placebo + letrozole (HR=0.57 [95% CI: 0.46-0.70]; P<0.0001)^4-6

See improved QoL across 3 phase III clinical trials >

Hear the latest from your peers >

Wolfgang Janni, MD
University of Ulm
Ulm, Germany
Dr Wolfgang Janni talks about how KISQALI^® (ribociclib) sets a new treatment standard with the latest MONALEESA-2 OS data.

David A. Cameron, MD
Edinburgh Cancer Research Centre
Edinburgh, UK
Dr David Cameron discusses what the latest OS data from the KISQALI^® (ribociclib) MONALEESA-2 trial can mean for your patients.

Gabriel Hortobagyi, MD
MD Anderson Cancer Center
Houston, TX
Dr Gabriel Hortobagyi discusses how the latest OS data with KISQALI from MONALEESA-2 has the potential to be practice changing.

1L, first line; aBC, advanced breast cancer; AI, aromatase inhibitor; CDK, cyclin-dependent kinase; CI, confidence interval; HR, hazard ratio; LET, letrozole; mPFS, median progression-free survival; OS, overall survival; QoL, quality of life.

References: 1. Data on file. Novartis Pharma AG; 2021. 2. Rugo HS, Finn RS, Dieras V, et al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat. 2019;174:719-729. 3. Johnston S, Martin M, Di Leo A, et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. npj Breast Cancer. 2019;5(5). doi:10.1038/s41523-018-0097-z 4. KISQALI [Summary of Product Characteristics]. Novartis Pharma AG; 2019. 5. Hortobagyi G, Stemmer S, Burris H, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375:1738-1748. doi: 10.1056/NEJMoa1609709 6. Hortobagyi G, Stemmer S, Burris H, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018;29:1541-1547. doi:10.1093/annonc/mdy155