TABLE 3.
Localized mRECIST, n (%) | mRECIST, n (%) | RECIST 1.1, n (%) | |
---|---|---|---|
ORR, confirmed response, n (%) [95% CI] | 117 (72.2%) [64.9%, 78.5%] | 111 (68.5%) [61.0%, 75.2%] | 75 (46.3%) [38.8%, 54.0%] |
ORR, best response, n (%) [95% CI] | 143 (88.3%) [82.4%, 92.4%] | 140 (86.4%) [80.3%, 90.9%] | 102 (63.0%) [55.3%, 70.0%] |
Best overall response | |||
CR | 136 (84%) | 133 (82.1%) | 13 (8.0%) |
PR | 7 (4.3%) | 7 (4.3%) | 89 (54.9%) |
Stable disease | 0 | 0 | 38 (23.5%) |
PD | 0 | 3 (1.9%) | 3 (1.9%) |
NE | 19 (11.7%) | 19 (11.7%) | 19 (11.7%) |
No imaging assessments after day 46 | 5 (3.1%) | 5 (3.1%) | 5 (3.1%) |
No imaging assessments after day 46 due to LT or resection | 9 (5.6%) | 9 (5.6%) | 9 (5.6%) |
Other reasons | 5 (3.1%) | 5 (3.1%) | 5 (3.1%) |
DoR* in months, mean (SD), median | 15.1 (11.2), 11.8 | 14.0 (10.5), 10.6 | 13.8 (10.4), 10.6 |
DoR* ≥ 6 months, n (%) [95% CI] | 89 (76.1%) [67.6%, 82.9%] | 83 (74.8%) [66.0%, 81.9%] | 54 (72%) [61.0%, 80.9%] |
DoR based the number of confirmed responders by BICR (n = 117 for localized mRECIST, n = 111 for mRECIST, and n = 75 for RECIST.