Table II.
Efficacy results of registration studies of targeted therapies
| Class | Agent | Trial | Progression Free Survival | Objective Response | ||||
|---|---|---|---|---|---|---|---|---|
| N | Number of events (%) |
Median in months, (95% CI) |
N | Objective Response Rate (%) |
CI (%) | |||
| CDK 4/6 Inhibitor | Abemaciclib | MONARCH-1 [53] | 132 | NR | 6.0, (4.2-7.5) 5.9, (3.7-8.1) |
132 | 26 (19.7) 23 (17.4) |
13.3-27.5 11.4-25.0 |
| MONARCH-2 [48] | 446 | 222 (49.8) | 16.4, (14.4-19.3) | 318 | 153 (48.1) | 42.6-53.6 | ||
| MONARCH-3 [44] | 328 | 108 (32.9)* | NR | 267 | 158 (59.2) | 53.3-65.1 | ||
| Palbociclib | PALOMA-1 [96] | 84 | 41 (48.8) | 10.2, (5.7-12.6) | 65 | 36 (55.4) | 43.0-68.0 | |
| PALOMA-2 [41] | 444 | 194 (43.7) | 24.8, (22.1-NE) | 338 | 55.3 (49.9) | 49.9-60.7 | ||
| PALOMA-3 [46] | 347 | 145 (41.8) | 9.5, (9.2-11.0) | 268 | 66 (24.6) | 19.6-30.2 | ||
| Ribociclib | MONALEESA-2 [39] | 334 | 93 (27.8) | NR, (19.3-NR) | 256 | 52.7 (20.6) | 46.6-58.9 | |
| MONALEESA-3 [47] | 484 | 210 (43) | 20.5, (18.5-23.5) | 379 | 155 (40.9) | 35.9-45.8 | ||
| PI3K Inhibitor | Alpelisib | SOLAR-1 [62] | 169 | 103 (61) | 11.0, (7.5-14.5) | 126 | 45.0 (35.7) | 27.4-44.7 |
| mTOR Inhibitor | Everolimus | BOLERO-2 [71] | 485 | NR | 7.8, (6.9, 8.5) 11.0, (9.7, 15.0) |
485 | 61.1 (12.6) | 9.8-15.9 |
NR = Not Reported
NE = Not Estimable
*
Number of patients with an event