Table 3.
Response to adavosertib treatment
| Cohort | Adavosertib dose (schedule) |
ORR, CP + PR/n (%) |
DCR, CP + PR + SD/n (%)d |
SDe | Median PFS, months (95% CI) |
|||
|---|---|---|---|---|---|---|---|---|
| ≥ 7 or 8 weeksf |
> 12 weeks | < 12 weeks | 12 weeks, not confirmed |
|||||
| bid 1 (n = 6) | 125 mg bid (5/9) | 0a | 4 (66.7) | 4 (66.7) | 3 (50.0) | 0 | 1 (16.7) | 3.7 (1.5–5.5) |
| bid 2 (n = 6) | 150 mg bid (5/9) | 1/5 (20.0)b | 2 (33.3) | 1 (16.7) | 1 (16.7) | 0 | 0 | 1.9 (1.0–NC) |
| qd 1.1 (n = 5) | 200 mg qd (5/9) | 0 | 2 (40.0) | 2 (40.0) | 2 (40.0) | 0 | 0 | 2.0 (0.6–NC) |
| qd 1.2 (n = 6) | 200 mg qd (5/2) | 1/5 (20.0)b | 2 (33.3) | 1 (16.7) | 1 (16.7) | 0 | 0 | 2.7 (1.2–9.0) |
| qd 2.1 (n = 4) | 250 mg qd (5/9) | 0 | 1 (25.0) | 1 (25.0) | 1 (25.0) | 0 | 0 | 1.9 (1.8–4.1) |
| qd 2.2 (n = 3) | 250 mg qd (5/2) | 0 | 2 (66.7) | 2 (66.7) | 2 (66.7) | 0 | 0 | 3.7 (1.2–11.0) |
| qd 2.3 (n = 10) | 250 mg qd (5/2 weekly) | 0 | 3 (30.0) | 3 (30.0) | 2 (20.0) | 0 | 1 (10.0) | 2.1 (0.6–4.1) |
| qd 3.1 (n = 4) | 300 mg qd (5/9) | 0 | 3 (75.0) | 3 (75.0) | 2 (50.0) | 0 | 1 (25.0) | 7.6 (2.7–9.3) |
| qd 3.2 (n = 16) | 300 mg qd (5/2) | 0 | 11 (68.8) | 11 (68.8) | 7 (43.8) | 1 (6.3) | 3 (18.8) | 3.2 (2.1–5.0) |
| qd 3.3 (n = 2) | 300 mg (5/2 weekly) | 0 | 0 | 0 | 0 | 0 | 0 | 2.6 (NC–NC) |
| Total (N = 62) | 2/58c (3.4) | 30/62 (48.4) | 28/62 (45.2) | 21/62 (33.9) | 1/62 (1.6) | 6/62 (9.7) | 2.7 (2.0–3.8) | |
None of the patients had a complete response. aOne patient in the bid 1 cohort had a partial response in the target lesion but progressive disease in non-target lesions; bPatients with a partial response had anal cancer (qd 1.2) and a thymoma (bid 2); cNumber of patients with measurable disease at baseline. Four patients in the bid 2, qd 1.2, qd 2.3 and qd 3.2 cohorts did not have measurable target lesions at baseline; dDCR was defined as the proportion of patients with a confirmed (after 4 weeks) BOR of CR or PR; or a BOR of SD for at least 8 weeks for qd 5/2 schedules, or at least 7 weeks for other schedules; eSD > 12 weeks indicates confirmed SD for more than 12 weeks; SD < 12 weeks means that SD was achieved as per protocol definition, but the disease progressed on or before week 12; 12 weeks not confirmed indicates that SD (BOR) was achieved as per protocol definition, but it is unknown if it lasted for 12 weeks or more; fSD for at least 8 weeks for qd 5/2 schedules, or at least 7 weeks for other schedules). BOR, best objective response; CR, complete response; NC, not calculable; PR, partial response; SD, stable disease