Table 3.
Confirmed systemic and intracranial objective response rate and best overall response
| Confirmed systemic objective response rate and best overall response | ||||||
|---|---|---|---|---|---|---|
| T-DXd |
T-DM1 |
|||||
| Overall population (n= 261) | Patients with BMs (n = 43) | Patients without BMs (n = 218) | Overall population (n = 263) | Patients with BMs (n = 39) | Patients without BMs (n = 224) | |
| Confirmed ORR,an [% (95% CI)] | 208 [79.7 (74.3-84.4)] | 29 [67.4 (51.5-80.9)] | 179 [82.1 (76.4-87.0)] | 90 [34.2 (28.5-40.3)] | 8 [20.5 (9.3-36.5)] | 82 [36.6 (30.3-43.3)] |
| CR | 42 (16.1) | 2 (4.7) | 40 (18.3) | 23 (8.7) | 0 | 23 (10.3) |
| PR | 166 (63.6) | 27 (62.8) | 139 (63.8) | 67 (25.5) | 8 (20.5) | 59 (26.3) |
| SD | 44 (16.9) | 11 (25.6) | 33 (15.1) | 112 (42.6) | 22 (56.4) | 90 (40.2) |
| PD | 3 (1.1) | 1 (2.3) | 2 (0.9) | 46 (17.5) | 7 (17.9) | 39 (17.4) |
| Not evaluable | 6 (2.3) | 2 (4.7) | 4 (1.8) | 15 (5.7) | 2 (5.1) | 13 (5.8) |
| CR + PR + SD (DCR) | 252 (96.6) | 40 (93.0) | 212 (97.2) | 202 (76.8) | 30 (76.9) | 172 (76.8) |
| mDOR (95% CI), months | Not evaluable (20.3-not evaluable) | 12.9 (8.5-not evaluable) | Not evaluable (20.3-not evaluable) | Not evaluable (12.6-not evaluable) | 7.2 (2.8-not evaluable) | Not evaluable (12.6-not evaluable) |
|
Intracranial response as per blinded independent central reviewb | ||||||
|---|---|---|---|---|---|---|
| T-DXd (n = 35) | T-DM1 (n = 35) | |||||
| Best overall response,an (%) | ||||||
| Patients with objective response of CR or PR, n | 23 | 12 | ||||
| CR | 10 (28.6) | 1 (2.9) | ||||
| PR | 13 (37.1) | 11 (31.4) | ||||
| Non-CR/non-PD | 6 (17.1) | 7 (20.0) | ||||
| SD | 4 (11.4) | 7 (20.0) | ||||
| PD | 0 | 7 (20.0) | ||||
| Not evaluable | 0 | 1 (2.9) | ||||
| Missing | 2 (5.7) | 1 (2.9) | ||||
BICR, blinded independent central review; BMs, brain metastases; CI, confidence interval; CR, complete response; DCR, disease control rate; mDOR, median duration of response; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan.
a
Based on BICR.
b
Table includes target and nontarget lesions.