Table 3.
Summary of efficacy
| Variable | All Patients (N = 67) | Ovarian Cancer (N = 31) | ||||
|---|---|---|---|---|---|---|
| All | QD | BID | All | QD | BID | |
| N = 67 | n = 18 | n = 49 | N = 31 | n = 7 | n = 24 | |
| Response rate, n (%)a | 13 (19.4) | 6 (33.3) | 7 (14.3) | 10 (32.3) | 4 (57.1) | 6 (25.0) |
| 95 % CIb | 10.8 to 30.9 | 13.3 to 59.0 | 5.9 to 27.2 | 16.7 to 51.4 | 18.4 to 90.1 | 9.8 to 46.7 |
| Best overall response, n (%) | ||||||
| Complete response | 6 (9.0) | 5 (27.8) | 1 (2.0) | 4 (12.9) | 3 (42.9) | 1 (4.2) |
| Partial response | 7 (10.4) | 1 (5.6) | 6 (12.2) | 6 (19.4) | 1 (14.3) | 5 (20.8) |
| Stable disease | 29 (43.3) | 5 (27.8) | 24 (49.0) | 14 (45.2) | 1 (14.3) | 13 (54.2) |
| Progressive disease | 13 (19.4) | 7 (38.9) | 6 (12.2) | 3 (9.7) | 2 (28.6) | 1 (4.2) |
| Not assessed | 12 (17.9) | 0.0 (0.0) | 12 (24.5) | 4 (12.9) | 0.0 (0.0) | 4 (16.7) |
| Median duration of response (range), moc | 6.7 (1.9 to 29.6) | 10.2 (1.9 to 29.6) | 5.6 (2.8 to 25.2) | 6.1 (1.9 to 29.6) | 7.4 (1.9 to 29.6) | 5.2 (2.8 to 25.2) |
| Median duration of stable disease (95 % CI), mod | 3.7 (2.8 to 4.1) | 2.8 – | 3.7 (2.8 to 4.1) | 3.9 (3.7 to 5.5) | – | 4.0 (3.7 to 11.3) |
| 6-month rate of duration (95 % CI) | 27.3 (11.2 to 43.4) | – | 24.2 (7.3 to 41.1) | 23.4 (3.4 to 43.4) | – | 25.2 (3.8 to 46.6) |
| Median time to disease progression or death (95 % CI), moe | 3.7 (2.7 to 5.5) | 2.8 (1.9 to 7.0) | 3.7 (2.7 to 5.5) | 8.3 (3.7 to 11.1) | 5.5 – | 8.3 (3.7 to 11.3) |
| 6-month TTP rate (95 % CI) | 35.9 (23.9 to 47.9) | 38.9 (17.9 to 59.9) | 34.4 (20.3 to 48.5) | 50.4 (32.4 to 68.4) | – | 52.6 (32.0 to 73.2) |
CI confidence interval; CR complete response; PD progressive disease; PR partial response; RECIST Response Evaluation Criteria in Solid Tumors; SD stable disease
aDefined as the proportion of patients achieving a CR plus PR using RECIST version 1.0
b95 % CI based on exact binomial probabilities
cMeasured from the date that measurement criteria are met for CR or PR until the first date of documented PD. Duration of response was censored at the date of the last assessment visit for responders with no evidence of PD
dMeasured from the date of the first dose until the first date of PD. Duration of SD was censored at the date of the last assessment visit for patients with SD with no evidence of PD
eDefined as the time from the date of the first enzastaurin or bevacizumab dose to the first date of PD. Time to disease progression was censored at the date of the last assessment visit for patients with no evidence of PD. Estimated using the Kaplan-Meier method