Theme

Clinical Data Summary • MONALEESA-2

MONALEESA-2: First-Line Ribociclib OS Benefit in HR+/HER2- Breast Cancer

Source
Source: Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer (MONALEESA-2). N Engl J Med. 2022;386:942-50.
Population
N=668 Postmenopausal
Experimental Arm
Ribociclib + Letrozole
Follow-Up
Median 80 Months
Median Overall Survival
63.9 Months
+12.5 Months vs. Placebo (51.4 mo)
Mortality Risk HR 0.76
24% Reduction
(95% CI, 0.63–0.93; P=0.008)

Clinical Benefit Duration

Chemo delayed by approx. 1 year

6-Year Survival Rate

44.2% of patients alive at 6 years

Standard of Care Recommendation

Based on the significant OS benefit exceeding 5 years and a consistent safety profile, Ribociclib + Letrozole is recommended as a preferred first-line regimen to maximize longevity and delay cytotoxic chemotherapy.

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. MONALEESA-2 ClinicalTrials.gov number, NCT01958021. (link)
  3. 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.
  4. 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.
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  7. Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3). Lancet Oncol 2016;17:425-39.
  8. 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.