MONALEESA-2

Source

Source: Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med. 2022;386:942-50. MONALEESA-2 (NCT01958021).

First-Line Ribociclib Breaks the 5-Year Survival Barrier in HR+/HER2- Advanced Breast Cancer

Absolute OS Improvement

12.5

Months

Study Architecture

Population (N=668)
Postmenopausal Women, HR+/HER2- Advanced Breast Cancer
Intervention (n=334)
Ribociclib + Letrozole
Control (n=334)
Placebo + Letrozole
Follow-up
Median 80 months (6.6 years)

Median Overall Survival

● Ribociclib vs ● Placebo

24%

Reduction in
Risk of Death

HR 0.76

44.2%

Alive at
6 Years

vs 32.0%

+1 Yr

Delayed
Chemotherapy

Median 50.6 vs 38.9

Clinical Recommendation: Standard of Care

Ribociclib plus Letrozole should be prioritized for postmenopausal women with HR+/HER2- advanced breast cancer. This regimen offers unprecedented survival benefits (>5 years median OS) and delays the need for cytotoxic chemotherapy.

AbbreviationsQuick

CDK4/6, cyclin-dependent kinases 4 and 6; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; ER, estrogen receptor; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; PgR, progesterone receptor.

Bibliography8

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