Phase 2 objective response rates
| Cohorts (n) | Tumor types | Best overall response, n (%) | ORR* n (%) 95% CI | DCR n (%) 95% CI | ||||
| CR | PR | SD | PD | NE | ||||
| 3 (n=20) | CRC | 0 | 1 (5.0)† | 4 (20.0) | 14 (70.0) | 1 (5.0) | 1 (5.0) (0.1 to 24.9) | 3 (15.0) (3.2 to 37.9) |
| 4 (n=17) | Ovarian | 0 | 2 (11.8) | 6 (35.3) | 4 (23.5) | 5 (29.4) | 2 (11.8) (1.5 to 36.4) | 8 (47.1) (23 to 72.2) |
| 4A (n=19) | 0 | 3 (15.8) | 4 (21.1) | 9 (47.4) | 3 (15.8) | 3 (15.8) (3.4 to 39.6) | 6 (31.6) (12.6 to 56.6) | |
| 4B (n=20) | 0 | 2 (10.0) | 6 (30.0) | 11 (55.0) | 1 (5.0) | 2 (10.0) (1.2 to 31.7) | 4 (20.0) (5.7 to 43.7) | |
| Total (n=56) | 0 | 7 (12.5) | 16 (28.6) | 24 (42.9) | 9 (16.1) | 7 (12.5) (5.2 to 24.1) | 18 (32.1) (20.3 to 46) | |
| 5 (n=6) | SCCHN | 0 | 1 (16.7) | 2 (33.3) | 2 (33.3) | 1 (16.7) | 1 (16.7) (0.4 to 64.1) | 3 (50.0) (11.8 to 88.2) |
| 5A (n=1) | 0 | 0 | 0 | 1 (100) | 0 | 0 (0.0) (0 to 97.5) | 0 (0.0) (0 to 97.5) | |
| 5B (n=17) | 1 (5.0) | 1 (5.0) | 6 (35.3) | 5 (29.4) | 4 (23.5) | 2 (11.8) (1.5 to 36.4) | 5 (29.4) (10.3 to 56) | |
| Total (n=24) | 1 (4.2) | 2 (8.3) | 8 (33.3) | 8 (33.3) | 5 (20.8) | 3 (12.5) (2.7 to 32.4) | 8 (33.3) (15.6 to 55.3) | |
| 6 (n=20) | GBM | 0 | 2 (10.0) | 4 (20.0) | 13 (65.0) | 1 (5.0) | 2 (10.0) (1.2 to 31.7) | 6 (30.0) (11.9 to 54.3) |
| 7 (n=13) | RCC | 0 | 0 | 5 (38.5) | 7 (53.8) | 1 (7.7) | 0 (0.0) (0 to 24.7) | 4 (30.8) (9.1 to 61.4) |
*Only confirmed responses are included.
†The patient was determined to have microsatellite instability-high tumor prior to enrolling in the study.
CR, complete response; CRC, colorectal cancer; DCR, disease control rate; GBM, glioblastoma; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; RCC, renal cell carcinoma; SCCHN, squamous cell carcinoma of the head and neck; SD, stable disease.