Table 1.
Summary of published studies with T-DM1
| Trial name | Patients, n | Treatment groups | Results | Reference |
|---|---|---|---|---|
| Phase 1 | ||||
| TDM3569g | ||||
| Cohort 1 | 24 | Dose escalation, T-DM1 q3 weeks | ORR, 44%; CBR, 73% | 17 |
| Cohort 2 | 28 | Dose escalation, T-DM1 q1 week | ORR, 46.4% | 18 |
| Phase 2 | ||||
| TDM4258g | 112 | T-DM1: 3.6 mg/kg IV q3 weeks | PFS, 4.6 months; ORR, 26% | 20 |
| TDM4374g | 110 | T-DM1: 3.6 mg/kg IV q3 weeks | PFS, 7.3 months; ORR, 35%; CBR, 48% | 21 |
| TDM4450g | 137 | T-DM1: 3.6 mg/kg IV versus docetaxel + trastuzumab | PFS, 14.2 months; ORR, 64% | 22 |
| TDM4373g | 64 | T-DM1: 3.6 mg/kg IV + pertuzumab 840 mg loading dose followed by 420 mg IV q3 weeks | PFS, 6.6 months; ORR, 57% | 23 |
| Phase 3 | ||||
| EMILIA | 991 | T-DM1: 3.6 mg/kg IV q3 weeks versus capecitabine + lapatinib | OS, 30.9 months; PFS, 9.6 months; ORR, 44% | 24 |
| TH3RESA | 602 | T-DMI: 3 mg/kg IV q3 weeks versus physician choice | PFS, 6.2 months; ORR, 31% | 25 |
Abbreviations: T-DM1, trastuzumab emtansine; q1, weekly; q3; every 3 weeks; ORR, objective response rate; CBR, clinical benefit rate defined as objective response plus stable disease lasting at least 6 months; IV, intravenous; PFS, progression-free survival; OS, overall survival; EMILIA, An Open-label Study of Trastuzumab Emtansine (T-DM1) vs Capecitabine + Lapatinib in Patients With HER2-positive Locally Advanced or Metastatic Breast Cancer; TH3RESA, A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician’s Choice in Patients With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy; HER2, human growth factor receptor 2.