Tumour response to AMG 404 per modified RECIST V.1.1 in solid tumours by dose levels
| AMG 404 240 mg (n=3) | AMG 404 480 mg (n=144) | AMG 404 1050 mg (n=21) | All dose cohorts (n=168) | |
| Complete response (CR) | 0 | 4 (2.8) | 0 | 4 (2.4) |
| Partial response (PR) | 0 | 28 (19.4) | 1 (4.8) | 29 (17.3) |
| Stable disease (SD) | 2 (66.7) | 49 (34.0) | 8 (38.1) | 59 (35.1) |
| Progressive disease (PD) | 1 (33.3) | 50 (34.7) | 10 (47.6) | 61 (36.3) |
| Not evaluable (NE) | 0 | 2 (1.4) | 1 (4.8) | 3 (1.8) |
| Not done | 0 | 11 (7.6) | 1 (4.8) | 12 (7.1)* |
| Complete response (CR) rate | 0 | 4 (2.8) | 0 | 4 (2.4) |
| 80% CI† | (0, 53.6) | (1.2, 5.5) | (0, 10.4) | (1.0, 4.7) |
| ORR (CR/PR) | 0 | 32 (22.2) | 1 (4.8) | 33 (19.6) |
| 80% CI† | (0, 53.6) | (17.8, 27.3) | (0.5, 17.3) | (15.7, 24.1) |
| DCR (CR/PR/SD) | 2 (66.7) | 81 (56.3) | 9 (42.9) | 92 (54.8) |
| 80% CI† | (19.6, 96.6) | (50.6, 61.8) | (27.8, 59.1) | (49.5, 59.9) |
| PFS, median, months | 2.9 | 3.7 | 1.8 | 3.7 |
| 80% CI | (1.5, NE) | (3.5, 5.5) | (1.7, 4.5) | (3.5, 4.5) |
Data are presented as number (%) of patients, unless indicated otherwise.
One patient in the AMG 404 240 mg cohort had intrapatient dose escalation to 480 mg after cycle 4.
DCR was defined as the proportion of patients in whom objective response (CR or PR) or SD was determined as per modified RECIST V.1.1.
ORR was defined as a tumour response assessment of either CR or PR measured by PET/CT, CT or MRI and assessed per modified RECIST V.1.1.
PFS was defined as the time from the first dose until first documentation of radiological disease progression or death due to any cause, whichever occurred first in the absence of subsequent anticancer therapy. PFS was censored at the last evaluable postbaseline tumour assessment date before subsequent anticancer therapy or, otherwise, at the first dose of AMG 404.
The safety analysis set comprised all patients who received ≥1 dose of AMG 404.
*Twelve patients were considered NE in the BOR assessment as they had discontinued the study due to death (n=9) or consent withdrawal (n=3) prior to the first planned assessment.
†Binomial proportion with exact 80% CI.
‡Calculated using the Brookmeyer and Crowley method.
BOR, best overall response; DCR, disease control rate; ORR, objective response rate; PET, positron emission tomography; PFS, progression free survival; RECIST, Response Evaluation Criteria in Solid Tumours.