Theme

First-Line Ribociclib + Letrozole

Source
Source: Hortobagyi GN, et al. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med. 2022;386:942-50. DOI: 10.1056/NEJMoa2114663.

MONALEESA-2 Phase 3 Results: Median Overall Survival in HR+/HER2- Advanced Breast Cancer

ABS. OS IMPROVEMENT
12.5
MONTHS

Ribociclib vs. Placebo

0.76
HAZARD RATIO

95% CI: 0.63–0.93
P=0.008

Study Architecture

  • N=668 (Postmenopausal)
  • 1:1 Randomization
  • Arm A: Ribociclib + Let.
  • Arm B: Placebo + Let.

Median Overall Survival

Ribociclib arm exceeded 5 years median survival.

6-Year Survival Rate

Estimated probability at 72 months.

Safety Profile

MEDIAN EXPOSURE
20.2 Months
(Ribociclib)
LONG-TERM SAFETY
No New Signals
Consistent profile

Clinical Implication

Ribociclib + Letrozole supports its role as a standard-of-care 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. 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): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol 2016; 17:425-39.
  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. 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.
  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.
  5. 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.
  6. 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 that progressed on endocrine therapy — MONARCH 2: a randomized clinical trial. JAMA Oncol 2020; 6:116-24.
  7. 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.
  8. ClinicalTrials.gov. MONALEESA-2 ClinicalTrials.gov number, NCT01958021.