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The first CDK4/6 inhibitor trial to show that adding the pill to hormone therapy makes women live longer, by about a year.
PFS 25.3 vs 16.0 months (HR 0.57); final OS 63.9 vs 51.4 months (HR 0.76, P=0.004), the first OS benefit for a CDK4/6 inhibitor in first-line postmenopausal disease and the longest median OS reported in this setting at the time. With MONALEESA-3 and -7 it established ribociclib as the CDK4/6 inhibitor with the most consistent survival data.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
668 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Ribociclib + letrozole | 334 | 25.3 months | 0.57 (0.46 to 0.7) | - | link |
| Placebo + letrozole | 334 | 16 months | ||||
| Overall survival | Ribociclib + letrozole | 334 | 63.9 months | 0.76 (0.63 to 0.93) | 0.004 | link |
| Placebo + letrozole | 334 | 51.4 months |
A second publication from the MONALEESA-2 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT01958021 with the most citations, so it is the natural first reading for anyone following the MONALEESA-2 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares Gabriel N. Hortobagyi, Ribociclib, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors.
Shares Letrozole (and other aromatase inhibitors), CDK4/6, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors.
Shares Ribociclib, CDK4/6, Estrogen receptor (ERα), HR-positive / HER2-negative breast cancer.
Shares Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer, Ribociclib, CDK4/6, HR-positive / HER2-negative breast cancer.
Shares Gabriel N. Hortobagyi, Ribociclib, CDK4/6, Estrogen receptor (ERα).
Shares Letrozole (and other aromatase inhibitors), CDK4/6, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors.
Shares Ribociclib, CDK4/6 inhibitors, Novartis, HR-positive / HER2-negative breast cancer.
Shares CDK4/6, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.