Table 2.
Efficacy outcomes in mITT population.
| Arm B (N = 24) | Arm C (N = 13) | Arm D (N = 30) | |
|---|---|---|---|
| 6-month PFSa, % (95% CI) | 10.0 (2.7–35.4) | 7.7 (1.2–50.6) | 17.2 (7.8–38.3) |
| Progression free at 6 months, n (%) | 2 (8.3) | 1 (7.7) | 5 (16.7) |
| Median PFS, months (95% CI) | 1.6 (1.2–3.2) | 1.9 (1.8–14.9) | 1.9 (1.8–3.0) |
| Median OS, months (95% CI) | 10.5 (4.9–17.0) | 8.5 (7.3–NE) | 10.2 (7.0–15.4) |
| BOR, n (%) | 2 (8.3) | 1 (7.7) | 3 (10.0) |
| 95% CI | (1.0–27.0) | (0.2–36.0) | (2.1–26.5) |
| CR, n (%) | 0 (0) | 0 (0) | 1 (3.3) |
| 95% CI | NE | NE | (0.1–17.2) |
| PR, n (%) | 2 (8.3) | 1 (7.7) | 2 (6.7) |
| 95% CI | (1.0–27.0) | (0.2–36) | (0.8–22.1) |
| SD, n (%) | 6 (25.0) | 4 (30.8) | 7 (23.3) |
| 95% CI | (9.8–46.7) | (9.1–61.4) | (9.9–42.3) |
| PD, n (%) | 15 (62.5) | 8 (61.5) | 17 (56.7) |
| 95% CI | (40.6–81.2) | (31.6–86.1) | (37.4–74.5) |
Abbreviation: NE, not evaluable.
aSurvival rate point estimates are presented for 6-month PFS using the Kaplan–Meier method. One patient from Arm C who did not undergo efficacy evaluation is not included in the efficacy analyses.