TABLE 2.
Tumor Responses as Assessed by the BIRC
| End Point | RC48-C005 (n = 43) | RC48-C009 (n = 64) | Overall (n = 107) |
|---|---|---|---|
| Confirmed objective response rate, % (95% CI) | 51.2 (35.5 to 66.7) | 50.0 (37.2 to 62.8) | 50.5 (40.6 to 60.3) |
| IHC2+ and FISH+ or IHC3+ | 60.0 (36.1 to 80.9) | 64.0 (42.5 to 82.0) | 62.2 (46.5 to 76.2)a |
| IHC2+ and FISH– | 40.0 (19.1 to 63.9) | 39.4 (22.9 to 57.9) | 39.6 (26.5 to 54.0)a |
| IHC2+ and FISH unknown | 66.7 (9.4 to 99.2) | 50.0 (11.8 to 88.2) | 55.6 (21.2 to 86.3)a |
| Best overall response, No. (%) (95% CI) | |||
| Complete response | 0 (0.0) (0.2 to 6.6) | 2 (3.1) (0.4 to 10.8) | 2 (1.9) (0.2 to 6.6) |
| Partial response | 22 (51.2) (38.8 to 58.5) | 30 (46.9) (34.3 to 59.8) | 52 (48.6) (38.8 to 58.5) |
| Stable disease | 17 (39.5) (23.1 to 41.5) | 17 (26.6) (16.3 to 39.1) | 34 (31.8) (23.1 to 41.5) |
| Progressive disease | 3 (7.0) (8.1 to 22.1) | 12 (18.8) (10.1 to 30.5) | 15 (14.0) (8.1 to 22.1) |
| Not evaluable | 1 (2.3) (1.0 to 9.3) | 3 (4.7) (1.0 to 13.1) | 4 (3.7) (1.0 to 9.3) |
| DCR, No. (%) (95% CI) | 39 (90.7) (77.9 to 97.4) | 49 (76.6) (64.3 to 86.2) | 88 (82.2) (73.7 to 89.0) |
| Duration of response, months (95% CI) | 7.0 (4.7 to 12.4) | 8.3 (4.3 to 12.6) | 7.3 (5.7 to 10.8) |
| PFS | |||
| Median, months (95% CI) | 6.9 (5.4 to 9.0) | 5.3 (4.0 to 7.2) | 5.9 (4.3 to 7.2) |
| 12-month rate, % (95% CI) | 23.6 (11.5 to 38.1) | 25.3 (15.0 to 36.9) | 24.7 (16.5 to 33.7) |
| OS | |||
| Median, months (95% CI) | 13.9 (9.1 to NE) | 14.8 (8.7 to 18.6) | 14.2 (9.7 to 18.8) |
| 18-month rate, % (95% CI) | 46.3 (30.9 to 60.3) | 39.6 (27.2 to 51.6) | 42.2 (32.5 to 51.5) |
| OS follow-up, months, median | 19.6 | 23.4 | 20.5 |
Abbreviations: BIRC, blinded independent review committee; DCR, disease control rate; FISH, fluorescence in situ hybridization; IHC, immunohistochemistry; NE, not estimable; OS, overall survival; PFS, progression-free survival.
a
There is no statistical difference among the three subgroups for C005, C009, and overall with P = .4441, P = .1649, and P = .0798, respectively.