Table 2 The efficacy and survival among evaluable HER2-positive patients in the phase Ib and phase II studies
| Ā | GC | Other tumors | |||
|---|---|---|---|---|---|
| Ā | 1st-line treatment (nā=ā38) | ā„2nd-line treatment (nā=ā27) | CRC (nā=ā22) | Non-CRCa (nā=ā12) | Total (nā=ā34) |
Best overall response | |||||
āCR | 1 (2.6%) | 0 | 0 | 0 | 0 |
āPR | 29 (76.3%) | 12 (44.4%) | 10 (45.5%) | 8 (66.7%) | 18 (52.9%) |
āSD | 4 (10.5%) | 11 (40.7%) | 11 (50.0%) | 2 (16.7%) | 13 (38.2%) |
āPD | 3 (10.5%) | 4 (14.8%) | 1 (4.5%) | 2 (16.7%) | 3 (8.8%) |
Objective response rate (ORR, 95%CI) | 78.9% (62.7%, 90.4%) | 44.4% (25.5%, 64.7%) | 45.5% (24.4%,67.8%) | 66.7% (34.9%, 90.1%) | 52.9%(35.1%, 70.2%) |
Disease control rate (DCR, 95%CI) | 89.5% (75.2%, 97.1%) | 85.2% (66.3%, 95.8%) | 95.5% (77.2%, 99.9%) | 83.3% (51.6%, 97.6%) | 91.2% (76.3%, 98.1%) |
Clinical benefit rate (CBR, 95%CI) | 78.9% (62.7%, 90.4%) | 51.9% (31.9%, 71.3%) | 54.5 (32.2%, 75.6%) | 66.7% (34.9%, 90.1%) | 58.8% (40.7%, 75.4%) |
Duration of response (DoR, 95%CI) | 13.4 (8.3, NE) | 10.8 (4.0, NE) | 8.1 (3.2, NE) | NE (11.1, NE) | 5.0 (4.1, 15.2) |
Progression-free survival (PFS, 95%CI) | 11.0 (5.5, 16.5) | 5.3 (3.6, 12.6) | 5.6 (3.7, 16.6) | 25.0 (6.0, 50.5) | 5.6 (3.9, 8.2) |
Overall survival (OS, 95%CI) | NE (16.5, NE) | 17.9 (8.7, NE) | NE (19.2, NE) | 16.7 (2.7, 41.3) | NE (19.2, NE) |
6-month progression-free rate | 62.4% (44.8%, 75.7%) | 47.6% (27.1%, 65.6%) | 45.5% (23.2%, 65.3%) | 25.0% (6.0%, 50.5%) | 37.2% (20.8%, 53.7%) |
12-month progression-free rate | 46.4% (29.3%, 62.0%) | 30.3% (12.0%, 51.1%) | 39.7% (18.6, 60.2%) | 16.7% (2.7%, 41.3%) | 30.5% (15.5%, 46.9%) |
