Table 2 Best overall response in the premenopausal population of the MONARCH 2 trial
Overall population | Abemaciclib + fulvestrant N = 72 | Placebo + fulvestrant N = 42 | P value | ||
|---|---|---|---|---|---|
n (%) | 95% CI | n (%) | 95% CI | ||
CR | 2 (2.8) | − 1.0, 6.6 | 0 (0) | – | |
PR | 29 (40.3) | 28.9, 51.6 | 8 (19.0) | 7.2, 30.9 | |
SD | 30 (41.7) | 30.3, 53.1 | 27 (64.3) | 49.8, 78.8 | |
≥ 6 months | 25 (34.7) | 23.7, 45.7 | 21 (50.0) | 34.9, 65.1 | |
Progressive disease | 8 (11.1) | 3.9, 18.4 | 6 (14.3) | 3.7, 24.9 | |
Not evaluable | 3 (4.2) | − 0.4, 8.8 | 1 (2.4) | − 2.2, 7.0 | |
Overall response rate (CR + PR) | 31 (43.1) | 31.6, 54.5 | 8 (19.0) | 7.2, 30.9 | .009 |
Disease control rate (CR + PR + SD) | 61 (84.7) | 76.4, 93.0 | 35 (83.3) | 72.1, 94.6 | .845 |
Clinical benefit rate (CR + PR + SD ≥ 6 months) | 56 (77.8) | 68.2, 87.4 | 29 (69.0) | 55.1, 83.0 | .304 |
Measurable disease population | Abemaciclib + fulvestrant N = 51 | Placebo + fulvestrant N = 28 | P value | ||
|---|---|---|---|---|---|
n (%) | 95% CI | n (%) | 95% CI | ||
CR | 2 (3.9) | − 1.4, 9.2 | 0 (0.0) | – | |
PR | 29 (56.9) | 43.3, 70.5 | 8 (28.6) | 11.8, 45.3 | |
SD | 11 (21.6) | 10.3, 32.9 | 16 (57.1) | 38.8, 75.5 | |
≥ 6 months | 7 (13.7) | 4.3, 23.2 | 12 (42.9) | 24.5, 61.2 | |
Progressive disease | 7(13.7) | 4.3, 23.2 | 4 (14.3) | 1.3, 27.2 | |
Not evaluable | 2 (3.9) | − 1.4, 9.2 | 0 (0.0) | – | |
Overall response rate (CR + PR) | 31 (60.8) | 47.4, 74.2 | 8 (28.6) | 11.8, 45.3 | .006 |
Disease control rate (CR + PR + SD) | 42 (82.4) | 71.9, 92.8 | 24 (85.7) | 72.8, 98.7 | .702 |
Clinical benefit rate (CR + PR + SD ≥ 6 months) | 38 (74.5) | 62.5, 86.5 | 20 (71.4) | 54.7, 88.2 | .768 |