Theme

Breakthrough in First-Line Care

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 ClinicalTrials.gov number, NCT01958021.

Ribociclib + Letrozole extends Median Overall Survival to >5 Years in Advanced HR+/HER2- Breast Cancer.

Median Overall Survival
63.9 Months
+12.5 Months vs Placebo
Risk Reduction
24% Relative Reduction
HR: 0.76 (95% CI: 0.63–0.93)
P=0.008

MONALEESA-2 Protocol

  • N=668 Postmenopausal, HR+/HER2-, no prior systemic tx.
  • Intervention: Ribociclib (600mg) + Letrozole.
  • Control: Placebo + Letrozole.
  • Follow-up: Median 80 months.

Efficacy Milestones (Median Months)

Comparison of Overall Survival (OS) and Time to First Chemotherapy.

Long-Term Survival (6 Years)

Percentage of patients alive at the 72-month benchmark.

Recommendation: Standard of Care

Ribociclib plus Letrozole should be adopted as the preferred first-line standard of care. The data demonstrates a clinically meaningful extension of life exceeding five years—a milestone previously unreached in this setting—with a significant delay in the need for chemotherapy (median 50.6 months).

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
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