Efficacy outcomes by subgroup
| Efficacy outcome . | Tumors (<5 cm) (N = 68) . | Tumors (≥5 cm) (N = 43) . |
|---|---|---|
| ORR %, (95% CI) | 69% (56.7%, 79.8%) | 63% (46.7%, 77.0%) |
| CR %, (95% CI) | 27% (16.5%, 38.6%) | 16% (6.8%, 30.7%) |
| Median DOR (range), mo | NE (14.9, NE) | 16 (5.6, 22.6) |
| Median PFS (range), mo | 16.6 (8.3, 22.1) | 7.3 (5.2, 16.6) |
| Median OS (range), mo | NE (17.9, NE) | 15.6 (6.3, NE) |
| Efficacy outcome . | Tumors (<5 cm) (N = 68) . | Tumors (≥5 cm) (N = 43) . |
|---|---|---|
| ORR %, (95% CI) | 69% (56.7%, 79.8%) | 63% (46.7%, 77.0%) |
| CR %, (95% CI) | 27% (16.5%, 38.6%) | 16% (6.8%, 30.7%) |
| Median DOR (range), mo | NE (14.9, NE) | 16 (5.6, 22.6) |
| Median PFS (range), mo | 16.6 (8.3, 22.1) | 7.3 (5.2, 16.6) |
| Median OS (range), mo | NE (17.9, NE) | 15.6 (6.3, NE) |
| . | Bulky tumors (<10 cm) (N = 102) . | Bulky tumors (≥10 cm) (N = 9) . |
|---|---|---|
| ORR %, (95% CI) | 67% (56.6%, 75.7%) | 67% (29.9%, 92.5%) |
| CR %, (95% CI) | 24% (15.7%, 33.0%) | 11% (0.3%, 48.2%) |
| Median DOR (range), mo | 22.6 (14.9, NE) | 14.9 (3.0, 18.8) |
| Median PFS (range), mo | 13.9 (6.6, 17.5) | 7.4 (1.7, 19.2) |
| Median OS (range), mo | 22.8 (15.6, NE) | 13.7 (2.7, NE) |
| . | Bulky tumors (<10 cm) (N = 102) . | Bulky tumors (≥10 cm) (N = 9) . |
|---|---|---|
| ORR %, (95% CI) | 67% (56.6%, 75.7%) | 67% (29.9%, 92.5%) |
| CR %, (95% CI) | 24% (15.7%, 33.0%) | 11% (0.3%, 48.2%) |
| Median DOR (range), mo | 22.6 (14.9, NE) | 14.9 (3.0, 18.8) |
| Median PFS (range), mo | 13.9 (6.6, 17.5) | 7.4 (1.7, 19.2) |
| Median OS (range), mo | 22.8 (15.6, NE) | 13.7 (2.7, NE) |
| . | Prior treatments <2 (N = 22) . | Prior treatments ≥2 (N = 89) . |
|---|---|---|
| ORR %, (95% CI) | 82% (59.7%, 94.8%) | 63% (52.0%, 72.9%) |
| CR %, (95% CI) | 27% (10.7%, 50.2%) | 21% (13.4%, 31.3%) |
| Median DOR (range), mo | 16.5 (3.7, NE) | 17.5 (14.8, NE) |
| Median PFS (range), mo | 17.5 (4.9, NE) | 10.9 (6.0, 16.7) |
| Median OS (range), mo | 21.8 (10.0, NE) | 22.7 (13.0, NE) |
| . | Prior treatments <2 (N = 22) . | Prior treatments ≥2 (N = 89) . |
|---|---|---|
| ORR %, (95% CI) | 82% (59.7%, 94.8%) | 63% (52.0%, 72.9%) |
| CR %, (95% CI) | 27% (10.7%, 50.2%) | 21% (13.4%, 31.3%) |
| Median DOR (range), mo | 16.5 (3.7, NE) | 17.5 (14.8, NE) |
| Median PFS (range), mo | 17.5 (4.9, NE) | 10.9 (6.0, 16.7) |
| Median OS (range), mo | 21.8 (10.0, NE) | 22.7 (13.0, NE) |
| . | Nonrefractory (N = 29) . | Refractory (N = 35) . |
|---|---|---|
| Median DOR (range), mo | 18.8 (9.2, NE) | 15.8 (3.4, NE) |
| Median PFS (range), mo | 16.6 (6.0, 24.4) | 6.6 (3.5, 17.5) |
| Median OS (range), mo | NE (13.2, NE) | 13.0 (6.3, NE) |
| . | Nonrefractory (N = 29) . | Refractory (N = 35) . |
|---|---|---|
| Median DOR (range), mo | 18.8 (9.2, NE) | 15.8 (3.4, NE) |
| Median PFS (range), mo | 16.6 (6.0, 24.4) | 6.6 (3.5, 17.5) |
| Median OS (range), mo | NE (13.2, NE) | 13.0 (6.3, NE) |
CI, confidence interval; CR, complete response; DOR, duration of response; NE, nonevaluable; ORR, overall response rate; OS, overall survival; PFS, progression-free survival.