Table 2.
Anti-tumor activity in the ITT population
| Variable | Zolbetuximab plus CAPOX (n = 254) | Placebo plus CAPOX (n = 253) |
|---|---|---|
| ORRa | ||
| No. of patients | 108 | 102 |
| % (95% CI) | 42.5 (36.36–48.85) | 40.3 (34.22–46.64) |
| BOR, n (%) | 210 (82.7) | 226 (89.3) |
| CR | 9 (3.5) | 5 (2.0) |
| PR | 99 (39.0) | 97 (38.3) |
| SD | 46 (18.1) | 57 (22.5) |
| PD | 11 (4.3) | 28 (11.1) |
| Non-CR/Non-PD | 40 (15.7) | 33 (13.0) |
| NE | 1 (0.4) | 5 (2.0) |
| ND | 4 (1.6) | 1 (0.4) |
| Missingb | 44 | 27 |
| Median DORa,c, months (range) | 6.14 (5.03–8.08) | 6.08 (4.44–6.34) |
aPer RECIST version 1.1 by IRC.
bPatients with missing data had no post-baseline imaging assessment.
cDOR is reported among patients with an objective response.
BOR, best overall response; CR, complete response; ND, no disease; NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease.