MONALEESA-2: Ribociclib Shows 63.9 Month Median OS in Advanced BC

Theme

MONALEESA-2: Landmark Overall Survival Results

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 trial; NCT01958021)

First-Line Ribociclib + Letrozole in Advanced HR+/HER2- Breast Cancer

Median Overall Survival
63.9
Months
Longest reported median OS in this Phase 3 setting

Study Design

Population (N=668) Postmenopausal, HR+/HER2- Advanced Breast Cancer (First-line).
Arm A (n=334) Ribociclib + Letrozole
Arm B (n=334) Placebo + Letrozole
Median Follow-up: 80 months
Median Overall Survival (Months)
5-Year Survival Probability (%)
24%
Relative Risk Reduction
HR 0.76 (95% CI, 0.63–0.93)
P=0.008
+12.5
Months Absolute Gain
Median OS Extension vs Placebo
>5 Yr
Long-Term Durability
52.3% of Ribociclib patients alive at 60 months

Clinical Recommendation: Preferred First-Line Standard of Care

With a statistically significant 12+ month survival benefit and a consistent safety profile, Ribociclib + Letrozole is strongly validated for postmenopausal patients with HR+/HER2- advanced breast cancer to maximize upfront survival outcomes.

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.
  3. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med. 2019;381:307-16.
  4. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382:514-24.
  5. Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo... (PALOMA-3): final analysis. Lancet Oncol. 2016;17:425-39.
  6. Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35:3638-46.
  7. Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer... MONARCH 2. JAMA Oncol. 2020;6:116-24.
  8. Turner NC, Slamon DJ, Ro J, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med. 2018;379:1926-36.
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