Table 3.
Best response per RECIST v1.1 (intent-to-treat population).
| Response, n (%) | ACY-241 180 mg (n = 4) |
ACY-241 360 mg (n = 5) |
ACY-241 480 mg (n = 9) |
Total (N = 18) |
|---|---|---|---|---|
| Best response | ||||
| Complete response | 1 (25) | 0 | 0 | 1 (6) |
| Partial response | 2 (50) a | 3 (60) a | 0 | 5 (28) |
| Stable disease | 0 | 1 (20) c | 1 (11) | 2 (11) |
| Progressive disease | 0 | 1 (20) | 3 (33) | 4 (22) |
| Not evaluable | 1 (25) b | 0 | 5 (56) b | 6 (33) |
| Overall response rate | 3 (75) | 3 (60) a | 0 | 6 (33) |
PD-L1, programmed death ligand 1; RECIST, Response Evaluation Criteria in Solid Tumors.
a
One patient with known PD-L1 status was PD-L1 negative.
b
Patient discontinued before tumor assessment or did not reach first postbaseline tumor assessment. One patient withdrew consent, 2 patients had progressive disease before nivolumab treatment, 2 patients discontinued due to adverse events, and 1 patient died before the first tumor assessment.
c
One patient had an unconfirmed partial response before progression.