Table 1.
Summary of Clinical Trial Data for CDK4/6 Inhibitors for HR+/HER2− Advanced Breast Cancer
| Study | Phase | Arms | Description | Median PFS HR (95% CI) |
ORR | Median OS HR (95% CI) |
|
|---|---|---|---|---|---|---|---|
| First-line | PALOMA-1/ TRIO-18 | II | 2 | Palbociclib/letrozole vs letrozole | 20.2 vs 10.2 mo 0.488 (0.319–0.748) | 55.0% vs 39.0% | 37.5 vs 34.5 mo 0.897 (0.623–1.294) |
| PALOMA-2 | III | 2 | Palbociclib/letrozole vs placebo/letrozole | 24.8 vs 14.5 mo 0.58 (0.46–0.72) | 55.3% vs 44.4% | Pending | |
| MONALEESA-2 | III | 2 | Ribociclib/letrozole vs placebo/letrozole | 25.3 vs 16.0 mo 0.568 (0.457–0.704) | 52.7% vs 37.1% | Pending | |
| MONALEESA-7 | III | 2 | Ribociclib/OFS/AI or tamoxifen vs placebo/OFS/AI or tamoxifen | 23.8 vs 13.0 mo 0.553 (0.441–0.694) | 51.0% vs 36.0% | Pending | |
| MONARCH-3 | III | 2 | Abemaciclib/AI vs placebo/AI | NR vs 14.7 mo 0.543 (0.409–0.723) | 59.0% vs 44.0% | Pending | |
| Second-line | PALOMA-3 | III | 2 | Palbociclib/fulvestrant vs placebo/fulvestrant | 9.5 vs 4.6 mo 0.46 (0.36–0.59) | 24.6% vs 15.0% | Unknown |
| MONARCH-2 | III | 2 | Abemaciclib/fulvestrant vs placebo/fulvestrant | 16.4 vs 9.3 0.553 mo (0.449–0.681) | 48.1% vs 21.3% | Pending | |
| Later-line | MONARCH-1 | II | 1 | Abemaciclib | 6.0 mo | 19.7% | 17.7 mo |
AI = aromatase inhibitor; HR = hazard ratio; OFS = ovarian function suppression; ORR = objective response rate; OS = overall survival; PFS = progression-free survival.