MONALEESA-2: Ribociclib Extends OS to Over 5 Years

Theme

MONALEESA-2: Final Overall Survival

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. Data derived from the MONALEESA-2 Clinical Trial (NCT01958021).

First-Line Ribociclib + Letrozole extends median overall survival beyond 5 years in postmenopausal HR+/HER2- Advanced Breast Cancer.

Population (N)
668
Postmenopausal HR+/HER2-
Follow-Up
80 mo
Median Duration
Study Design
Phase 3
RCT, Placebo-Controlled

Median Overall Survival

63.9 Months
Ribociclib Arm

+12.5 Month absolute survival gain vs. Placebo (51.4 mo).

Risk Reduction

24% Relative Reduction
in Risk of Death
Hazard Ratio: 0.76 (95% CI, 0.63–0.93)
P=0.008

Time to Chemotherapy

Delayed need for subsequent chemotherapy by nearly 1 year (11.7 months).

HR 0.74 (95% CI, 0.61–0.91)

Recommendation: Standard of Care

With the longest reported median overall survival in this setting, Ribociclib + Letrozole is a preferred first-line treatment for postmenopausal patients with HR+/HER2- advanced breast cancer.

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, could not be estimated; PgR, progesterone receptor.
Bibliography8
  1. 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)
  2. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016;375:1738-48.
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