Table 2. BICR-assessed best overall response.
Responses | Margetuximab plus chemotherapy (n=55) | Trastuzumab plus chemotherapy (n=56) |
---|---|---|
Overall best response, n (%) | ||
Confirmed CR | 0 | 1 (1.8) |
Confirmed PR | 14 (25.5) | 6 (10.7) |
SD | 33 (60.0) | 29 (51.8) |
PD | 6 (10.9) | 17 (30.4) |
NE | 2 (3.6) | 3 (5.4) |
ORR, n (%) | 14 (25.5) | 7 (12.5) |
95% CI | 14.67, 39.00 | 5.18, 24.07 |
P value | 0.083 | |
CBR, n (%) | 18 (32.7) | 8 (14.3) |
95% CI | 20.68, 46.71 | 6.38, 26.22 |
P value | 0.025 | |
DoR (months), median | NR | 7.00 |
95% CI | 4.14, NE | 2.33, 7.20 |
BICR, blinded independent central review; CR, complete response; PR, partial response; SD, stable disease; PD, disease progression; NE, not evaluable; ORR, objective response rate; CI, confidence interval; CBR, clinical benefit rate; DoR, duration of remission; NR, not reached.