Table 3.
Efficacy responses (modified full analysis set, N = 47).
| Efficacy outcome | Patients, n (%) unless stated |
|---|---|
| BOR | |
| CR | 2 (4.3) |
| PR | 9 (19.1) |
| SD | 18 (38.3) |
| PD | 14 (29.8) |
| Not evaluable | 4 (8.5) |
| ORR, N (%), (90% CI) | 11 (23.4) (13.7, 35.8) |
| DCR, N (%), (90% CI) | 29 (61.7) (48.7, 73.6) |
| Median PFS (months), (90% CI) | 4.0 (2.8, 6.0) |
| Median OS (months), (90% CI) | 12.4 (7.8, 14.5) |
| Median DOR (months), (90% CI) | 6.0 (5.1, nd) |
DCR was defined as the proportion of patients with disease control, defined as a BOR of CR, PR, or SD.
BOR best overall response, CI confidence interval, CR complete response, DCR disease control rate, DOR duration of response, nd not defined, ORR overall response rate, OS overall survival, PD progressive disease, PFS progression-free survival, PR partial response, SD stable disease.