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Abemaciclib roughly doubled the time to progression when added to an aromatase inhibitor; the survival gain of about 13 months narrowly missed statistical significance.
MONARCH 3, trial NCT02246621 sponsored by Eli Lilly and reported in 2017, showed that abemaciclib roughly doubled the time to progression when added to a non-steroidal aromatase inhibitor as first-line treatment for postmenopausal HR-positive, HER2-negative advanced breast cancer. It randomised 493 women and met its primary progression-free survival endpoint, and the final overall survival analysis showed a numerical gain of about thirteen months that narrowly missed statistical significance at the prespecified threshold. OnCo links it to CDK4/6 as a target, abemaciclib, aromatase inhibitors, Matthew P. Goetz and the bottleneck of wrong doses, and MONARCH 2, which tested abemaciclib with fulvestrant after endocrine progression, did show a significant survival benefit. Whether a large numerical survival gain that misses significance should count is the question the trial leaves open.
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.
493 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Abemaciclib + NSAI | 328 | 28.2 months | 0.54 (0.42 to 0.7) | - | link |
| Placebo + NSAI | 165 | 14.8 months | ||||
| Overall survival | Abemaciclib + NSAI | - | 66.8 months | 0.8 (0.62 to 1.03) | 0.066 | link |
| Placebo + NSAI | - | 53.7 months |
Shares Abemaciclib, CDK4/6, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Eli Lilly (incl. Loxo).
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.
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 Abemaciclib, Eli Lilly (incl. Loxo), CDK4/6 inhibitors.
Shares Abemaciclib, Eli Lilly (incl. Loxo), CDK4/6 inhibitors.
Shares Abemaciclib, Eli Lilly (incl. Loxo), 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 Abemaciclib, Eli Lilly (incl. Loxo), CDK4/6 inhibitors.