Theme

MONALEESA-2: Landmark Survival Data

Ribociclib + Letrozole demonstrates statistically significant overall survival benefit in first-line HR+/HER2- advanced breast cancer.

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. doi:10.1056/NEJMoa2114663.
Design
Phase 3, N=668
1:1 Randomized
Population
Postmenopausal
HR+/HER2- Advanced
Follow-Up
Median 6.6 Years
(80 Months)
Median Overall Survival
63.9 Months
Longest reported mOS in this setting (>5 years)
Absolute Benefit
+12.5 Mo
vs. Placebo (51.4)
Hazard Ratio
0.76
24% Risk Reduction

Survival Outcomes

Recommendation: Preferred Standard of Care

Ribociclib plus letrozole is recommended for postmenopausal patients with HR+/HER2- advanced breast cancer. The regimen offers a substantial survival advantage with a well-characterized safety profile.

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; NE, not estimable; PgR, progesterone receptor.
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