TABLE 2.
Summary of Response by Investigator Assessment
| Parameter/Variable | Patients (N = 46) |
|---|---|
| Confirmed ORR,a No. (%) | 11 (23.9) |
| 95% CIb | 12.6 to 38.8 |
| Confirmed DCR,c No. (%) | 26 (56.5) |
| 95% CIb | 41.1 to 71.1 |
| Best overall response, No. (%) | |
| Confirmed CR | 1 (2.2) |
| Confirmed PR | 10 (21.7) |
| SD | 15 (32.6) |
| PD | 10 (21.7) |
| Not evaluabled | 10 (21.7) |
Abbreviations: CR, complete response; DCR, disease control rate; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.
Patients whose best overall response was confirmed CR or PR according to RECIST version 1.1.
Using exact method on the basis of binomial distribution (Clopper-Pearson).
Patients with best overall response of confirmed CR, confirmed PR, or SD (≥7 weeks).
Seven patients were considered not evaluable because of study discontinuation before postbaseline response assessment was performed, and three patients were considered not evaluable because of having only one postbaseline tumor assessment, which was completed before the protocol-specified minimum time of 49 days after the first dose.