MONALEESA-2
Trial question
What is the role of ribociclib plus letrozole in patients with HR+ HER2- advanced breast cancer?
Study design
Multi-center
Double blinded
RCT
Population
668 female patients.
Inclusion criteria: postmenopausal women with HR+/HER2- advanced breast cancer.
Key exclusion criteria: receipt of CDK4/6 inhibitor therapy; receipt of prior systemic anti-cancer therapy for advanced breast cancer; concurrent use of other anti-cancer therapy; concurrent malignancy or malignancy within 3 years of randomization; active cardiac disease or a history of cardiac dysfunction.
Interventions
N=334 ribociclib plus letrozole (ribociclib 600 mg PO daily for 21 consecutive days, followed by 7 days off, for a complete cycle of 28 days plus letrozole 2.5 mg/day).
N=334 placebo plus letrozole (matching placebo plus letrozole 2.5 mg/day).
Primary outcome
Median progression free survival
25.3 months
16 months
25.3 months
19.0 months
12.7 months
6.3 months
0.0 months
Ribociclib plus
letrozole
Placebo plus
letrozole
Significant
increase ▲
Significant increase in median progression free survival (25.3 months vs. 16 months; HR 1.76, 95% CI 1.42 to 2.19).
Secondary outcomes
Significant increase in median overall survival (63.9 months vs. 51.4 months; HR 1.32, 95% CI 1.08 to 1.59).
Borderline significant increase in objective response rate (42.5% vs. 28.7%; AD 13.8%, 95% CI -0.02 to 27.62).
Significantly longer median time to first subsequent chemotherapy (50.6 months vs. 38.9 months; HR 1.35, 95% CI 1.1 to 1.64).
Safety outcomes
Significant difference in grade 3 or 4 neutropenia (63.8% vs. 1.2%).
Conclusion
In postmenopausal women with HR+/HER2- advanced breast cancer, ribociclib plus letrozole was superior to placebo plus letrozole with respect to median progression free survival.
Reference
G N Hortobagyi, S M Stemmer, H A Burris 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 Jul 1;29(7):1541-1547.
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