Table 2.
Confirmed overall response by dose levels and by prior lines of therapy
| 250 mg | 300 mg | 350 mg | All | |
|---|---|---|---|---|
| All patients | ||||
| Number of evaluable patients | n = 2 | n = 21 | n = 50 | n = 73 |
| Complete response, n (%) | 0 | 0 | 0 | 0 |
| Partial response, n (%) | 0 | 0 | 10 (20.0) | 10 (13.7) |
| Stable diseasea, n (%) | 0 | 12 (57.1) | 22 (44.0) | 34 (46.6) |
| Progressive disease, n (%) | 2 (100) | 7 (33.3) | 16 (32.0) | 25 (34.2) |
| Not evaluable, n (%) | 0 | 2 (9.5) | 2 (4.0) | 4 (5.5) |
| ORR, %(95% CI) | 0 (0–84.2) | 0 (0–16.1) | 20.0 (10.0, 33.7) | 13.7 (6.8, 23.8) |
| DCR, %(95% CI) | 0 (0–84.2) | 57.1 (34.0–78.2) | 64.0 (49.2–77.1) | 60.3 (48.1–71.6) |
| Patients with 2 or more prior lines of systemic therapy | ||||
| Number of evaluable patients | n = 0 | n = 9 | n = 35 | n = 44 |
| Complete response, n (%) | NA | 0 | 0 | 0 |
| Partial response, n (%) | NA | 0 | 5 (14.3) | 5 (11.4) |
| Stable diseasea, n (%) | NA | 4 (44.4) | 15 (42.9) | 19 (43.2) |
| Progressive disease, n (%) | NA | 4 (44.4) | 13 (37.1) | 17 (38.6) |
| Not evaluable, n (%) | NA | 1 (11.1) | 2(5.7) | 3 (6.8) |
| ORR, % (95% CI) | NA | 0 (0.0–33.6) | 14.3 (4.8–30.3) | 11.4 (3.8–24.6) |
| DCR, % (95% CI) | NA | 44.4 (13.7–78.8) | 57.1 (39.4–73.7) | 54.5 (38.9–69.6) |
aStable disease ≥ 6 weeks