Table 2.
Best overall response: phase II part
| Xe1000+Ev10+Ex25 (n = 70) | Ev10+Ex25 (n = 70) | |
|---|---|---|
| Best overall response | ||
| CR | 1 (1.4) | 0 |
| PR | 4 (5.7) | 7 (10.0) |
| Non-CR/non-PD, n (%) | 10 (14.3) | 8 (11.4) |
| Non-CR/non-PD ≥ 24 weeks | 4 (5.7) | 3 (4.3) |
| SD, n (%) | 28 (40.0) | 32 (45.7) |
| SD ≥ 24 weeks | 4 (5.7) | 7 (10.0) |
| PD, n (%) | 16 (22.9) | 14 (20.0) |
| Not evaluable, n (%) | 11 (15.7) | 9 (12.9) |
| OR, n (%) | 5 (7.1) | 7 (10.0) |
| Odds ratio (95% CI) [P value]† | 0.70 (0.20–2.32) [P = 0.5598] | |
| Median time to OR, months (range) | 3.7 (1.8–5.3) | 1.8 (1.6–7.2) |
| Median duration of OR,‡ months (95% CI) | 5.6 (NC–NC) | NC (1.8–NC) |
| Disease control, n (%) | 13 (18.6) | 17 (24.3) |
| Odds ratio (95% CI) [P value]† | 0.70 (0.31–1.59) [P = 0.4008] | |
| Median duration of disease control,‡ months (95% CI) | NC (9.2–NC) | 9.3 (9.0–NC) |
CI confidence interval, CR complete response, NC not calculable, OR objective response, PD progressive disease, PR partial response, SD stable disease
†Odds ratio and P value are obtained from logistic regression model adjusted for visceral involvement at screening. An odds ratio > 1 favours Xe1000+Ev10+Ex25
‡Kaplan–Meier estimates