Table 2.
Summary of best overall response in the Japanese subpopulation of MONARCH 3
| Best overall responsea | All patients | Patients with measurable disease | ||||||
|---|---|---|---|---|---|---|---|---|
| Abemaciclib + NSAI (n = 38) | Placebo + NSAI (n = 15) | Abemaciclib + NSAI (n = 29) | Placebo + NSAI (n = 12) | |||||
| n (%) | 95% CIb | n (%) | 95% CIb | n (%) | 95% CIb | n (%) | 95% CIb | |
| Complete response (CR) | 0 (0.0) | NA | 0 (0.0) | NA | 0 (0.0) | NA | 0 (0.0) | NA |
| Partial response (PR) | 18 (47.4) | 31.5, 63.2 | 6 (40.0) | 15.2, 64.8 | 18 (62.1) | 44.4, 79.7 | 6 (50.0) | 21.7, 78.3 |
| Stable disease (SD) | 17 (44.7) | 28.9, 60.5 | 8 (53.3) | 28.1, 78.6 | 8 (27.6) | 11.3, 43.9 | 5 (41.7) | 13.8, 69.6 |
| SD persistent for ≥ 6 months | 15 (39.5) | 23.9, 55.0 | 7 (46.7) | 21.4, 71.9 | 7 (24.1) | 8.6, 39.7 | 4 (33.3) | 6.7, 60.0 |
| Progressive disease (PD) | 0 (0.0) | NA | 1 (6.7) | − 6.0, 19.3 | 0 (0.0) | NA | 1 (8.3) | − 7.3, 24.0 |
| Objective PD | 0 (0.0) | NA | 1 (6.7) | − 6.0, 19.3 | 0 (0.0) | NA | 1 (8.3) | − 7.3, 24.0 |
| Not evaluable | 3 (7.9) | − 0.7, 16.5 | 0 (0.0) | NA | 3 (10.3) | − 0.7, 21.4 | 0 (0.0) | NA |
| Objective response rate (CR + PR) | 18 (47.4) | 31.5, 63.2 | 6 (40.0) | 15.2, 64.8 | 18 (62.1) | 44.4, 79.7 | 6 (50.0) | 21.7, 78.3 |
| Disease control rate (CR + PR + SD) | 35 (92.1) | 83.5, 100.7 | 14 (93.3) | 80.7, 106.0 | 26 (89.7) | 78.6, 100.7 | 11 (91.7) | 76.0, 107.3 |
| Clinical benefit rate (CR + PR + SD ≥ 6 months) | 33 (86.8) | 76.1, 97.6 | 13 (86.7) | 69.5, 103.9 | 25 (86.2) | 73.7, 98.8 | 10 (83.3) | 62.2, 104.4 |
Data cut-off date: November 3, 2017
CI, confidence interval; n, number of patients in category or group; NA, not applicable; NSAI, nonsteroidal aromatase inhibitor; RECIST, Response Evaluation Criteria in Solid Tumors
aResponse was determined by investigators using RECIST version 1.1
bCIs were based on normal approximation