MONALEESA-2: Ribociclib + Letrozole PFS 25.3 Months

Theme

MONALEESA-2 Update

Source
Source: Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018;29(7):1541-1547.

Ribociclib + Letrozole Sustains Dominant 25.3-Month PFS in First-Line Advanced Breast Cancer

Median PFS

25.3 months
vs. 16.0 months (Placebo)
+9.3 Months Gain

Study Architecture

  • N=668 Postmenopausal, HR+/HER2-
  • Phase III, Randomized (1:1)
  • Intervention: Ribociclib + Letrozole
  • Control: Placebo + Letrozole
  • Follow-up: 26.4 months median

Efficacy

Hazard Ratio: 0.568
43% Risk Reduction

Safety

Grade 3/4 Neutropenia
52.4%
vs. 1.2% (Placebo)
Manageable: Only 8.1% permanent discontinuation rate.

Standard First-Line Therapy

With a 9.3-month PFS advantage, Ribociclib + Letrozole is a priority regimen. Implement standard monitoring (CBC, ECG) to manage toxicity.

AbbreviationsQuick
AE, adverse event; AI, aromatase inhibitor; CI, confidence interval; ctDNA, circulating tumor DNA; ECG, electrocardiogram; ECOG PS, Eastern Cooperative Oncology Group performance status; HER2–, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; LFT, liver function test; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; QTcF, QT interval corrected by Fridericia’s formula; RECIST, Response Evaluation Criteria in Solid Tumors; RTK, receptor tyrosine kinase; TAM, tamoxifen.
Bibliography1
  1. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018;29(7):1541-1547. (DOI: 10.1093/annonc/mdy155)
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