Theme

MONALEESA-2: Overall Survival Analysis

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. This publication reports results from the MONALEESA-2 trial (NCT01958021).

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

Population
668 Patients
Postmenopausal, HR+/HER2-
Design
Phase 3 RCT
Double-blind, Placebo-controlled
Follow-Up
80 Months
Median duration (6.6 Years)
Median Overall Survival
63.9 Months
First CDK4/6i combination to exceed 5 years in this setting.
Hazard Ratio
0.76
24% Relative Risk Reduction
(P=0.008)
Absolute Benefit
+12.5
Months survival advantage over Placebo
5-Year Survival Rate
Ribociclib Arm 52.3%
Placebo Arm 43.9%

Median Overall Survival (Months)

Overall Survival Probability Over Time

Clinical Recommendation

Adopt Ribociclib + Letrozole as a preferred first-line standard of care. The data confirms that PFS benefit translates into a statistically significant and clinically robust extension of overall life (>5 years), delaying the need for chemotherapy with a manageable safety profile.

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. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016;375:1738-48.
  2. 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.
  3. Cardoso F, Paluch-Shimon S, Senkus E, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol 2020;31:1623-49.
  4. National Comprehensive Cancer Network. Metastatic breast cancer. 2020. (link)
  5. 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.
  6. 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.
  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 that progressed on endocrine therapy — MONARCH 2: a randomized clinical trial. JAMA Oncol 2020; 6:116-24.
  8. 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.