Table 4. Summary of best response to treatment (N = 23).
| Disease control | RECIST v1.1 by investigator assessment(n) | ConfirmedRECIST v1.1 by central radiology (n) | Duration of disease control, range (days) |
|---|---|---|---|
| CR | 0 | 0 | -- |
| PR | 4a | 2a | 21-151b |
| SD | 7 | 3c | 81-256 |
| PD | 5 | NA | NA |
| NE | 7 | NA | NA |
CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease; NE = not evaluable; NA = not applicable (progression was not required to be confirmed by central radiology assessment).
aTwo subjects (001 and 023) had a confirmed PR in at least two assessments that was confirmed by independent radiologic review. Two remaining subjects (002 and 004) did not meet the primary study endpoint of objective response (RECIST v1.1 criteria).
bCalculation based on investigator assessment (n=4).
cThree subjects (008, 009, 012) had confirmed SDs in at least two assessments, but no independent radiologic review was performed.