Table 3 Best overall anti-tumor response
Overall response (All patients) | Onatasertib 15 mg + Toripalimab 240 mg (n = 15) | Onatasertib 20 mg + Toripalimab 240 mg (n = 17) | Onatasertib 30 mg + Toripalimab 240 mg (n = 14) | All enrolled patients (n = 46) |
|---|---|---|---|---|
Complete response | 1 (6.7) | 0 | 0 | 1 (2.2) |
Partial response | 5 (33.3) | 4 (23.5) | 2 (14.3) | 11 (23.9) |
Stable disease | 8 (53.3) | 9 (52.9) | 5 (35.7) | 22 (47.8) |
Progressive disease | 1 (6.7) | 3 (17.6) | 4 (28.6) | 8 (17.4) |
Not evaluated | 0 | 1 (5.9) | 3 (21.4) | 4 (8.7) |
Objective response† (95% CI) | 40.0 (16.3,67.7) | 23.5 (6.8,49.9) | 14.3 (1.8,42.8) | 26.1 (14.3,41.1) |
Disease control‡ (95% CI) | 93.3 (68.1,99.8) | 76.5 (50.1, 93.2) | 50 (23,77.0) | 73.9 (58.9,85.7) |
Progression-free survival, months Median (95% CI) | 5.8 (3.3,9.6) | 4.1 (3.1, NE) | 3.1 (1.3,4.3) | 4.3 (3.5,7.2) |
Overall survival, months Median (95% CI) | 17.7 (4.6, NE) | 19.9 (8.3, NE) | 10.2 (5.5,16.4) | 15.7 (12.1,19.9) |
Overall response (Cervical cancer cohort) | (n = 10) | (n = 8) | (n = 3) | (n = 21) |
Complete response | 1 (10.0) | 0 | 0 | 1 (4.8) |
Partial response | 5 (50.0) | 3 (37.5) | 2 (66.7) | 10 (47.6) |
Stable disease | 4 (40.0) | 4 (50.0) | 0 | 8 (38.1) |
Progressive disease | 0 | 0 | 1 (33.3) | 1 (4.8) |
Not evaluated | 0 | 1 (12.5) | 0 | 1 (4.8) |
Objective response† (95% CI) | 60 (26.2,87.8) | 37.5 (8.5,75.5) | 66.7 (9.4,99.2) | 52.4 (29.8,74.3) |
Disease control‡ (95% CI) | 100 (69.2,100) | 87.5 (47.3,99.7) | 66.7 (9.4,99.2) | 90.5 (69.6,98.8) |
Progression-free survival, months Median (95% CI) | 7.8 (3.3, NE) | 4.1 (3.7, NE) | 5.5 (1.4, NE) | 5.8 (4.1,13.7) |
Overall survival, months Median (95% CI) | NE (4.6, NE) | NE (4.1, NE) | 18.4 (15.1, NE) | 18.4 (14.4, NE) |
