Theme

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

Study Design

Phase 3, Randomized, Double-blind, Placebo-controlled.

Population

N=668 Postmenopausal women. HR+/HER2- Advanced Breast Cancer.

Follow-Up

Long-term analysis. Median: 6.6 years (80 months).

Median Overall Survival (OS)

63.9 Mos
Ribociclib + Letrozole

+12.5 Months improvement vs. Placebo (51.4 mos).
Longest reported survival in this setting.

Survival Benefit

HR: 0.76
24%
Relative Reduction in Risk of Death
(P=0.008)

6-Year Survival Rate

Time to Chemo

50.6 Mos
Ribociclib Arm
38.9 Mos
Placebo Arm
Significant delay in need for cytotoxic treatment.

Clinical Recommendation

Adopt Ribociclib + Letrozole as a standard-of-care first-line regimen. This combination demonstrates a fundamental extension of life expectancy beyond 5 years with a manageable safety profile, fulfilling the primary goal of advanced cancer therapy.

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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