Table 2 Objective response and duration of response in total population
Squamous | Non-squamous | Cohorts 1-4 population (n = 60) | Cohort 5 population (n = 31) | |||
|---|---|---|---|---|---|---|
Cohort 1 (n = 17) | Cohort 2 (n = 11) | Cohort 3 (n = 12) | Cohort 4 (n = 20) | |||
Best overall response, n (%) | ||||||
CR | 0 | 0 | 0 | 0 | 0 | 0 |
PR | 10 (58.8) | 4 (36.4) | 5 (41.7) | 8 (40.0) | 27 (45.0) | 17 (54.8) |
SD | 6 (35.3) | 6 (54.5) | 6 (50.0) | 8 (40.0) | 26 (43.3) | 12 (38.7) |
PD | 1 (5.9) | 1 (9.1) | 1 (8.3) | 1 (9.1) | 4 (6.7) | 2 (6.5) |
Not evaluable | 0 | 0 | 0 | 0 | 0 | 0 |
Not able to be assesseda | 0 | 0 | 0 | 3 (15.0) | 3 (5.0) | 0 |
ORR, n (%) | 10 (58.8) | 4 (36.4) | 5 (41.7) | 8 (40.0) | 27 (45.0) | 17 (54.8) |
95% CI | (32.9, 81.6) | (10.9, 69.2) | (15.2, 72.3) | (19.1, 63.9) | (32.1, 58.4) | (36.0, 72.7) |
DCR, n (%) | 16 (94.1) | 10 (90.9) | 11 (91.7) | 16 (80.0) | 53 (88.3) | 29 (93.5) |
95% CI | (71.3, 99.9) | (58.7, 99.8) | (61.5, 99.8) | (56.3, 94.3) | (77.4, 95.2) | (78. 6, 99.2) |
Median DOR, months (95% CI) | NR | NR | NR | 9.9 (2.6-NE) | NR | 7.0 (4.2-NE) |
Patients with a response who had ongoing responses | ||||||
Rate (95% CI) at 3 months | 83.3% (48.2, 95.6) | 100% (100, 100) | 75.0% (12.8, 96.1) | 87.5% (38.7, 98.1) | 85.7% (66.2, 94.4) | 84.7% (59.7, 94.8) |
Rate (95% CI) at 6 months | 64.8% (31.0, 85.2) | 50.0% (5.8, 84.5) | 50.0% (5.8, 84.5) | 75.0% (31.5, 93.1) | 63.3% (42.5, 78.3) | 53.5% (27.4, 74.0) |
Rate (95% CI) at 9 months | 55.6% (23.7, 78.7) | NR | 50.0% (5.8, 84.5) | 62.5% (22.9, 86.1) | 55.9% (35.5, 72.1) | 44.6% (19.1, 67.4) |
